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令和 2年10月27日作成
一般的名称及び販売名
一般的名称： 汎用血液ガス分析装置 販売名 ： ABL800 FLEX システム
対象ロット、数量及び出荷時期
対象 ：1082台 出荷時期：平成17年3月24日〜令和2年10月22日 製造番号： 754R0010N003 754R0041N010 754R0042N001 754R0042N003 754R0065N005 754R0066N009 754R0069N003 754R0074N004 754R0076N007 754R0084N003 754R0084N004 754R0084N006 754R0089N003 754R0099N010 754R0104N001 754R0110N001 754R0117N005 754R0122N010 754R0125N007 754R0144N010 754R0148N008 754R0151N002 754R0151N010 754R0152N001 754R0152N003 754R0152N009 754R0161N003 754R0168N004 754R0197N001 754R0198N007 754R0205N001 754R0214N002 754R0214N007 754R0215N002 754R0216N001 754R0218N007 754R0243N011 754R0249N010 754R0249N012 754R0255N004 754R0260N007 754R0264N001 754R0264N009 754R0268N002 754R0268N003 754R0271N009 754R0272N008 754R0305N001 754R0316N009 754R0319N003 754R0319N004 754R0326N004 754R0326N011 754R0333N012 754R0342N011 754R0345N005 754R0346N003 754R0346N005 754R0346N009 754R0363N002 754R0363N007 754R0363N011 754R0364N001 754R0365N004 754R0367N010 754R0368N009 754R0369N008 754R0373N010 754R0373N012 754R0375N012 754R0377N011 754R0377N012 754R0379N012 754R0388N007 754R0396N008 754R0400N008 754R0402N010 754R0404N008 754R0410N012 754R0414N003 754R0419N003 754R0423N004 754R0437N009 754R0437N010 754R0437N012 754R0438N001 754R0446N003 754R0463N004 754R0464N007 754R0466N004 754R0501N004 754R0513N006 754R0517N001 754R0517N002 754R0517N012 754R0518N006 754R0527N009 754R0528N009 754R0540N007 754R0543N007 754R0545N006 754R0550N002 754R0572N004 754R0572N007 754R0572N009 754R0585N006 754R0591N008 754R0594N005 754R0594N010 754R0595N002 754R0595N005 754R0595N006 754R0595N007 754R0595N009 754R0596N007 754R0615N001 754R0615N008 754R0615N009 754R0631N003 754R0637N006 754R0645N003 754R0648N005 754R0659N004 754R0660N001 754R0660N003 754R0662N005 754R0662N006 754R0662N007 754R0663N001 754R0676N006 754R0676N008 754R0685N001 754R0689N003 754R0691N004 754R0691N005 754R0692N001 754R0692N003 754R0737N002 754R0748N003 754R0753N001 754R0757N002 754R0764N002 754R0766N003 754R0772N003 754R0776N005 754R0794N007 754R0795N002 754R0795N006 754R0806N002 754R0806N006 754R0812N008 754R0813N007 754R0814N001 754R0816N007 754R0816N008 754R0825N001 754R0833N001 754R0833N002 754R0847N004 754R0847N005 754R0855N001 754R0855N007 754R0858N007 754R0862N007 754R0872N001 754R0872N002 754R0872N006 754R0872N007 754R0873N002 754R0888N002 754R0888N003 754R0894N003 754R0899N003 754R0900N009 754R0901N001 754R0907N006 754R0907N007 754R0908N002 754R0911N002 754R0913N007 754R0914N003 754R0914N005 754R0918N002 754R0928N005 754R0942N009 754R0943N004 754R0943N005 754R0943N006 754R0945N001 754R0953N007 754R0957N006 754R0957N008 754R0959N004 754R0959N007 754R0962N002 754R0974N009 754R0975N001 754R0978N005 754R0978N009 754R0979N005 754R0979N006 754R0991N002 754R0991N007 754R0992N009 754R0996N004 754R0996N006 754R0996N008 754R0997N004 754R0998N003 754R0998N004 754R0998N005 754R1004N005 754R1004N007 754R1004N009 754R1005N007 754R1013N005 754R1018N003 754R1022N007 754R1031N006 754R1031N007 754R1032N001 754R1032N003 754R1041N002 754R1041N003 754R1042N003 754R1042N004 754R1042N005 754R1044N004 754R1044N008 754R1045N001 754R1045N003 754R1045N004 754R1045N005 754R1045N006 754R1045N008 754R1046N004 754R1046N007 754R1046N008 754R1047N003 754R1049N002 754R1060N004 754R1060N006 754R1063N007 754R1065N001 754R1065N002 754R1065N003 754R1065N007 754R1066N002 754R1066N006 754R1069N003 754R1069N004 754R1069N006 754R1071N005 754R1089N005 754R1100N007 754R1110N002 754R1113N002 754R1113N003 754R1113N005 754R1123N007 754R1125N002 754R1125N004 754R1125N006 754R1142N004 754R1142N005 754R1142N007 754R1154N002 754R1156N001 754R1156N002 754R1172N004 754R1173N007 754R1175N003 754R1176N002 754R1179N004 754R1183N001 754R1198N008 754R1201N007 754R1202N004 754R1202N007 754R1207N004 754R1208N007 754R1208N008 754R1214N001 754R1217N002 754R1217N003 754R1219N009 754R1220N001 754R1223N003 754R1223N005 754R1232N007 754R1234N009 754R1258N002 754R1258N004 754R1263N007 754R1267N005 754R1267N006 754R1271N001 754R1271N004 754R1271N007 754R1272N004 754R1273N006 754R1276N001 754R1276N006 754R1282N004 754R1282N005 754R1282N006 754R1282N007 754R1287N007 754R1288N001 754R1288N007 754R1291N004 754R1291N006 754R1293N003 754R1293N006 754R1293N007 754R1294N001 754R1295N002 754R1300N007 754R1323N006 754R1324N007 754R1326N003 754R1326N007 754R1331N001 754R1331N007 754R1336N003 754R1342N007 754R1346N004 754R1346N005 754R1347N007 754R1349N001 754R1349N003 754R1349N004 754R1358N004 754R1359N005 754R1359N008 754R1359N009 754R1366N002 754R1369N002 754R1369N003 754R1369N004 754R1374N001 754R1375N002 754R1375N005 754R1376N006 754R1376N007 754R1377N001 754R1385N003 754R1386N004 754R1392N005 754R1393N001 754R1397N009 754R1399N003 754R1399N004 754R1399N006 754R1400N002 754R1400N003 754R1400N004 754R1405N004 754R1405N005 754R1405N007 754R1406N007 754R1413N001 754R1414N003 754R1414N004 754R1414N005 754R1415N002 754R1415N003 754R1415N005 754R1416N005 754R1416N007 754R1431N002 754R1432N003 754R1433N002 754R1440N006 754R1444N003 754R1444N004 754R1444N005 754R1445N004 754R1445N005 754R1446N002 754R1447N001 754R1448N001 754R1448N003 754R1449N002 754R1449N007 754R1452N001 754R1456N006 754R1457N002 754R1457N004 754R1457N006 754R1458N006 754R1458N007 754R1459N001 754R1459N002 754R1461N005 754R1463N001 754R1463N002 754R1465N001 754R1465N007 754R1467N006 754R1469N008 754R1471N001 754R1471N003 754R1472N002 754R1472N004 754R1472N007 754R1489N006 754R1490N001 754R1490N005 754R1490N006 754R1490N007 754R1493N002 754R1493N003 754R1493N005 754R1493N007 754R1494N007 754R1497N002 754R1497N004 754R1498N001 754R1498N002 754R1498N003 754R1499N005 754R1508N003 754R1520N006 754R1522N002 754R1522N004 754R1522N005 754R1523N002 754R1523N003 754R1523N004 754R1523N005 754R1524N002 754R1524N008 754R1525N007 754R1525N008 754R1527N001 754R1527N002 754R1527N003 754R1527N008 754R1528N001 754R1528N002 754R1528N004 754R1529N005 754R1531N001 754R1534N001 754R1536N002 754R1536N004 754R1538N001 754R1538N002 754R1538N003 754R1538N004 754R1543N005 754R1543N006 754R1545N006 754R1546N002 754R1546N004 754R1546N005 754R1553N003 754R1556N001 754R1556N005 754R1556N007 754R1558N004 754R1558N005 754R1560N003 754R1560N004 754R1563N007 754R1569N001 754R1569N002 754R1572N001 754R1572N002 754R1572N003 754R1572N005 754R1572N007 754R1574N001 754R1574N003 754R1574N004 754R1575N002 754R1579N004 754R1586N006 754R1588N004 754R1589N003 754R1590N003 754R1590N004 754R1594N002 754R1600N001 754R1601N003 754R1601N005 754R1601N006 754R1602N001 754R1603N001 754R1608N004 754R1613N003 754R1613N004 754R1614N003 754R1615N002 754R1619N004 754R1622N001 754R1622N003 754R1622N004 754R1624N001 754R1638N001 754R1638N006 754R1639N005 754R1639N007 754R1639N008 754R1644N001 754R1644N005 754R1644N006 754R1649N006 754R1657N005 754R1657N008 754R1660N004 754R1660N005 754R1660N007 754R1661N001 754R1665N005 754R1670N006 754R1670N008 754R1671N003 754R1671N004 754R1671N007 754R1671N008 754R1682N007 754R1685N006 754R1685N008 754R1687N007 754R1691N002 754R1691N005 754R1691N006 754R1691N007 754R1696N007 754R1697N008 754R1698N003 754R1706N004 754R1707N005 754R1707N006 754R1707N007 754R1707N009 754R1708N001 754R1708N003 754R1721N003 754R1721N004 754R1721N005 754R1722N004 754R1726N004 754R1730N003 754R1730N004 754R1731N003 754R1731N004 754R1731N005 754R1731N007 754R1732N004 754R1732N005 754R1736N003 754R1736N004 754R1736N005 754R1736N006 754R1736N007 754R1737N004 754R1737N005 754R1737N006 754R1741N006 754R1742N002 754R1742N003 754R1742N004 754R1742N007 754R1743N001 754R1743N002 754R1746N006 754R1746N007 754R1747N001 754R1747N003 754R1747N007 754R1749N001 754R1751N003 754R1751N005 754R1751N006 754R1751N007 754R1754N003 754R1754N005 754R1754N006 754R1754N007 754R1755N004 754R1755N006 754R1755N007 754R1755N008 754R1756N008 754R1758N002 754R1761N002 754R1761N005 754R1762N001 754R1762N003 754R1763N001 754R1763N004 754R1768N004 754R1768N006 754R1779N004 754R1779N005 754R1780N001 754R1780N005 754R1804N006 754R1805N001 754R1807N003 754R1807N004 754R1807N005 754R1808N007 754R1828N007 754R1829N009 754R1854N002 754R1856N002 754R1857N003 754R1858N001 754R1858N006 754R1859N005 754R1859N008 754R1865N001 754R1865N002 754R1865N005 754R1865N006 754R1868N001 754R1868N002 754R1868N003 754R1869N002 754R1869N003 754R1869N006 754R1869N008 754R1870N002 754R1870N007 754R1871N002 754R1871N003 754R1872N002 754R1872N003 754R1872N006 754R1872N008 754R1874N003 754R1874N004 754R1874N005 754R1877N001 754R1881N002 754R1881N007 754R1881N008 754R1888N006 754R1888N007 754R1889N001 754R1889N002 754R1890N003 754R1890N004 754R1894N005 754R1894N006 754R1903N001 754R1903N003 754R1903N007 754R1906N006 754R1906N007 754R1907N005 754R1907N007 754R1907N008 754R1908N002 754R1908N007 754R1913N005 754R1915N007 754R1916N001 754R1916N004 754R1942N002 754R1942N003 754R1942N004 754R1942N005 754R1942N006 754R1945N003 754R1946N004 754R1948N003 754R1948N004 754R1953N001 754R1959N005 754R1961N001 754R1962N001 754R1974N005 754R1975N001 754R1975N003 754R1978N001 754R1978N002 754R1978N003 754R1981N002 754R1981N004 754R1982N002 754R1982N004 754R1982N005 754R1984N002 754R1985N001 754R1990N006 754R1999N001 754R2019N006 754R2024N005 754R2026N001 754R2026N003 754R2026N004 754R2028N001 754R2028N003 754R2031N002 754R2032N005 754R2032N007 754R2034N005 754R2034N007 754R2034N008 754R2040N005 754R2040N006 754R2041N001 754R2041N003 754R2041N004 754R2041N005 754R2041N007 754R2049N001 754R2054N001 754R2054N007 ]754R2058N007 754R2059N002 754R2059N003 754R2059N006 754R2060N002 754R2062N004 754R2062N006 754R2062N007 754R2064N001 754R2072N003 754R2073N001 754R2073N002 754R2073N003 754R2084N001 754R2084N002 754R2087N001 754R2087N002 754R2087N004 754R2089N003 754R2090N001 754R2091N005 754R2099N005 754R2100N002 754R2104N002 754R2104N006 754R2105N003 754R2106N001 754R2122N004 754R2122N006 754R2122N007 754R2123N001 754R2123N002 754R2123N003 754R2123N004 754R2123N005 754R2131N004 754R2131N006 754R2145N004 754R2147N003 754R2153N001 754R2153N002 754R2153N004 754R2153N005 754R2153N006 754R2155N001 754R2155N005 754R2174N006 754R2175N002 754R2185N006 754R2186N001 754R2186N003 754R2194N007 754R2195N005 754R2195N007 754R2196N001 754R2213N004 754R2213N005 754R2213N006 754R2215N005 754R2240N001 754R2240N002 754R2250N003 754R2259N001 754R2259N002 754R2260N004 754R2260N005 754R2260N006 754R2261N003 754R2261N006 754R2266N006 754R2266N007 754R2269N004 754R2270N002 754R2270N003 754R2270N004 754R2270N005 754R2277N004 754R2281N002 754R2284N001 754R2285N005 754R2285N006 754R2286N006 754R2289N002 754R2303N001 754R2311N002 754R2312N002 754R2312N004 754R2313N001 754R2313N003 754R2313N004 754R2317N003 754R2317N004 754R2318N001 754R2318N002 754R2326N008 754R2326N009 754R2328N007 754R2328N011 754R2335N005 754R2340N003 754R2342N005 754R2343N004 754R2346N002 754R2346N003 754R2346N004 754R2352N006 754R2352N007 754R2362N006 754R2362N007 754R2363N002 754R2364N001 754R2364N004 754R2364N006 754R2365N004 754R2407N003 754R2409N001 754R2409N002 754R2409N003 754R2409N005 754R2409N011 754R2409N012 754R2410N003 754R2411N003 754R2411N006 754R2414N002 754R2415N001 754R2415N002 754R2428N002 754R2428N004 754R2429N010 754R2442N007 754R2443N006 754R2444N004 754R2444N010 754R2445N001 754R2445N002 754R2452N002 754R2452N003 754R2453N002 754R2457N007 754R2457N008 754R2460N003 754R2461N004 754R2461N005 754R2461N006 754R2461N007 754R2461N008 754R2461N011 754R2461N016 754R2461N017 754R2462N009 754R2462N012 754R2465N001 754R2472N005 754R2472N006 754R2472N007 754R2474N001 754R2474N002 754R2474N004 754R2474N005 754R2474N007 754R2477N002 754R2477N003 754R2477N004 754R2483N003 754R2483N004 754R2484N002 754R2488N001 754R2489N001 754R2489N003 754R2492N005 754R2492N006 754R2492N007 754R2495N009 754R2495N010 754R2495N011 754R2495N012 754R2496N003 754R2496N005 754R2496N007 754R2503N001 754R2505N016 754R2505N017 754R2506N001 754R2506N015 754R2506N016 754R2506N017 754R2507N002 754R2507N003 754R2507N004 754R2507N005 754R2507N007 754R2507N008 754R2507N010 754R2509N002 754R2511N003 754R2512N002 754R2512N006 754R2514N001 754R2514N004 754R2515N011 754R2515N012 754R2516N005 754R2516N007 754R2519N004 754R2519N009 754R2519N012 754R2521N001 754R2521N020 754R2523N004 754R2523N006 754R2523N007 754R2523N014 754R2526N006 754R2526N007 754R2527N012 754R2529N013 754R2530N002 754R2531N006 754R2532N001 754R2532N003 754R2532N005 754R2532N006 754R2534N006 754R2534N007 754R2534N010 754R2535N005 754R2535N013 754R2538N006 754R2538N007 754R2538N011 754R2547N001 754R2547N007 754R2549N001 754R2549N002 754R2551N011 754R2552N008 754R2552N009 754R2555N001 754R2555N008 754R2556N013 754R2556N015 754R2563N005 754R2564N005 754R2564N008 754R2566N006 754R2571N003 754R2571N007 754R2571N009 754R2572N001 754R2574N010 754R2574N011 754R2574N014 754R2574N015 754R2577N004 754R2578N004 754R2578N006 754R2578N008 754R2583N005 754R2604N010 754R2605N004 754R2611N005 754R2612N001 754R2612N005 754R2614N006 754R2617N006 754R2617N007 754R2618N002 754R2618N007 754R2619N007 754R2620N002 754R2620N006 754R2621N001 754R2621N002 754R2621N003 754R2621N004 754R2625N003 754R2627N001 754R2627N002 754R2627N003 754R2627N004 754R2632N004 754R2632N005 754R2633N002 754R2634N001 754R2634N006 754R2635N001 754R2635N003 754R2635N005 754R2641N001 754R2641N003 754R2641N004 754R2644N004 754R2644N005 754R2650N002 754R2651N005 754R2651N006 754R2651N007 754R2651N010 754R2655N011 754R2661N015 754R2662N003 754R2662N011 754R2662N015 754R2663N001 754R2663N007 754R2663N010 754R2664N004 754R2666N002 754R2666N004 754R2667N001 754R2667N002 754R2667N004 754R2667N005 754R2667N012 754R2667N013 754R2668N007 754R2668N010 754R2668N011 754R2668N015 754R2669N006 754R2669N007 754R2669N008 754R2669N009 754R2669N010 754R2669N011 754R2670N001 754R2673N016 754R2673N017 754R2674N020 754R2675N003 754R2675N005 754R2675N009 754R2683N017 754R2683N018 754R2685N003 754R2688N001 754R2688N013 754R2688N017 754R2689N002 754R2689N003 754R2689N006 754R2689N011 754R2689N013 754R2691N011 754R2695N010 754R2695N011 754R2697N002 754R2697N014 754R2697N023 754R2697N024 754R2698N002 754R2698N010 754R2698N019 754R2698N020 754R2698N021 754R2710N030 754R2713N031 754R2720N035 754R2722N011 754R2723N008 754R2723N009 754R2723N010 754R2723N029 754R2723N030 754R2723N037 754R2724N008 754R2724N009
製造販売業者等名称
製造販売業者の名称 ： ラジオメーター株式会社 製造販売業者の所在地： 東京都品川区北品川4丁目7番35号 許可の種類 ： 第二種医療機器製造販売業 許可番号 ： 13B2X00079 輸入元製造業者：RADIOMETER MEDICAL ApS (デンマーク国)
改修理由
海外製造元より、当該医療機器へ付属品FLEXQモジュールを搭載した装置について、機器管理システムで あるAQURE、Radiance、HIS/LISシステムと接続し、特定の装置設定をされている場合で、かつ限定された 操作により患者情報の取り違いが発生する可能性があるとの報告を受けました。 特定の装置設定でかつ限定された操作は、通常の操作では行われることはないため、患者情報の取り違い が生じる可能性はごく稀です。 海外製造元で調査した結果、本事象はソフトウェアバグが原因であることが判明しました。原因である ソフトウェアのバグ修正しましたので、バージョンアップ改修を実施いたします。また、本事象につき まして、該当する施設に対し、既に情報提供を行い、注意喚起を実施しております。
危惧される具体的な健康被害
患者情報の取り違いが発生した場合、不必要な治療を行う可能性や、必要な治療の遅延が発生する可能性があり ます。患者の診断、治療は様々な臨床上の情報を総合的に判断して行われるものであり、当該装置の測定値のみ で医療処置が行われるものではありませんので、重篤な健康被害の発生はないものと考えております。 なお、現在までのところ国内において患者健康被害の報告はございません。
改修開始年月日
令和2年10月26日
効能・効果又は用途等
血液中のpH、pCO2、pO2、tHb、sO2、COHb、MetHb、HHb、O2Hb、HbF、カリウム、ナトリウム、 カルシウム、クロール、グルコース、ラクテート、Creaの各濃度を測定し、酸塩基平衡や酸素 化状態に関する演算パラメーターを必要に応じて印字する自動測定装置。
その他
該当製品の納入先は特定しておりますので、納入しました代理店及び医療機関に対して自主改修を行う旨を通知 し、自主改修を行います。
担当者及び連絡先
担当者 ： 品質保証・薬事統括室 QMS/Vigilance 鈴木 香織 連絡先 ： ラジオメーター株式会社 東京都品川区北品川4丁目7番35号 電話番号： 03-6311-7204 FAX番号 ： 03-3764-0577