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令和 4年 5月17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 ：2124台 出荷時期：2005/3/30〜2022/3/31 製造番号： 754R0010N005 754R0041N004 754R0041N010 754R0042N003 754R0065N005 754R0066N006 754R 0066N007 754R0066N009 754R0068N003 754R0068N007 754R0069N003 754R0074N002 754R0074 N004 754R0074N009 754R0076N006 754R0076N007 754R0076N008 754R0084N003 754R0089N004 754R0092N003 754R0092N009 754R0096N004 754R0098N007 754R0098N008 754R0098N009 754R0099N003 754R0099N010 754R0104N001 754R0104N010 754R0106N003 754R0106N006 754R 0106N010 754R0110N001 754R0110N002 754R0116N009 754R0117N002 754R0117N003 754R0117 N005 754R0117N006 754R0119N003 754R0119N004 754R0119N005 754R0122N010 754R0123N002 754R0123N010 754R0125N003 754R0125N004 754R0127N001 754R0138N003 754R0138N004 754R0138N005 754R0149N001 754R0149N003 754R0149N004 754R0149N010 754R0151N002 754R 0151N010 754R0152N001 754R0152N003 754R0152N005 754R0152N008 754R0155N001 754R0161 N003 754R0164N003 754R0164N004 754R0167N008 754R0168N001 754R0168N003 754R0168N004 754R0197N001 754R0198N007 754R0198N011 754R0199N006 754R0199N007 754R0200N001 754R0200N002 754R0200N003 754R0200N005 754R0204N012 754R0205N001 754R0206N005 754R 0207N007 754R0211N002 754R0214N002 754R0214N007 754R0214N009 754R0216N001 754R0216 N002 754R0217N004 754R0218N004 754R0218N007 754R0225N001 754R0227N003 754R0227N005 754R0233N011 754R0237N008 754R0238N005 754R0238N006 754R0243N011 754R0249N010 754R0249N012 754R0250N005 754R0250N007 754R0250N010 754R0251N009 754R0255N004 754R 0262N004 754R0262N007 754R0263N008 754R0263N011 754R0264N001 754R0264N004 754R0268 N002 754R0268N003 754R0271N009 754R0272N003 754R0272N004 754R0273N009 754R0305N001 754R0315N001 754R0316N007 754R0316N008 754R0317N004 754R0317N005 754R0317N010 754R0319N002 754R0319N003 754R0319N004 754R0319N005 754R0320N006 754R0320N010 754R 0321N006 754R0321N008 754R0321N009 754R0325N004 754R0326N004 754R0326N011 754R0328 N004 754R0333N012 754R0337N004 754R0339N006 754R0340N009 754R0341N001 754R0342N011 754R0346N005 754R0346N009 754R0363N002 754R0363N007 754R0363N011 754R0364N001 754R0364N005 754R0364N008 754R0365N004 754R0368N009 754R0368N011 754R0369N008 754R 0373N010 754R0375N012 754R0377N011 754R0377N012 754R0378N005 754R0379N004 754R0379 N012 754R0380N002 754R0380N003 754R0380N006 754R0388N007 754R0388N009 754R0388N010 754R0393N010 754R0396N001 754R0396N009 754R0400N008 754R0402N010 754R0403N035 754R0404N003 754R0404N007 754R0404N008 754R0404N009 754R0404N010 754R0405N005 754R 0407N005 754R0408N012 754R0409N001 754R0409N002 754R0410N001 754R0410N010 754R0410 N011 754R0414N003 754R0414N004 754R0414N005 754R0414N006 754R0414N008 754R0414N011 754R0415N002 754R0415N003 754R0416N010 754R0417N011 754R0423N004 754R0424N007 754R0424N008 754R0424N009 754R0425N002 754R0432N006 754R0432N009 754R0437N009 754R 0437N010 754R0437N012 754R0438N001 754R0438N002 754R0438N005 754R0440N011 754R0445 N003 754R0446N003 754R0448N006 754R0449N012 754R0460N006 754R0461N007 754R0462N004 754R0463N002 754R0464N007 754R0465N003 754R0466N001 754R0466N003 754R0466N004 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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4-7-35 御殿山トラストタワー 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、当該医療機器の下記特定の測定モードであるマイクロモード使用時にナトリウム測定値(以下、 cNa+)が稀に正または負のバイアスが生じる可能性があるとの報告を受けました。 ・キャピラリー - C95 μL ・キャピラリー - FLEXモード ・シリンジ - S95 μL, ・キャピラリー - C125 μL 本事象は上記マイクロモードでのcNa+パラメーター特有の事象であり、他の測定モードおよびパラメーターに影 響しないことが確認されています。 海外製造元で調査した結果、本事象はサンプル移動に関するソフトウェアと装置固有のハードウェアの組み合わ せが原因であることが確認されており、マイクロモードにおける測定時の流路プログラムを最適化したソフトウ ェアへと修正いたしましたので、バージョンアップ改修を実施いたします。
危惧される具体的な健康被害
本事象による不具合が発生した場合、cNa+値が正常な患者が低ナトリウム血症または高ナトリウム血症と診断さ れ、不必要な医学的処置が実施される可能性がありますが、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、国内外において本事象に伴った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4年5月11日
効能・効果又は用途等
本装置は、汎用血液ガス分析装置であり、全血中の次の項目を測定することができる。 （1）血液ガス：酸性度pH、酸素分圧pO2、二酸化炭素分圧pCO2 （2）電解質 ：カリウムcK+、ナトリウムcNa+、クロールcCl-、イオン化カルシウムcCa2+ （3）代謝項目：グルコースcGlu、ラクテートcLac、総ビリルビン濃度ctBil、クレアチニンcCrea （4）オキシメトリー：ヘモグロビン酸素飽和度sO2、総ヘモグロビン濃度ctHb、一酸化炭素ヘモグロビン分画FC OHb、メトヘモグロビン分画FMetHb、酸素化ヘモグロビン分画FO2Hb、脱酸素化ヘモグロビン分画FHHb、胎児ヘモ グロビン分画FHbF
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・薬事統括部門 鈴木 香織 連絡先 ： ラジオメーター株式会社 電話番号： 03-6311-7204 FAX番号 ： 03-3764-0577