BEUDAMED
    FDA Adverse Event Death Summary report: N

    HLM TUBING SET W/ SOFTLINE COATING

    MDR report key: 5007394 · Received August 13, 2015

    Report

    Report Number
    8010762-2015-00896
    Event Type
    Death
    Date Received
    August 13, 2015
    Date of Event
    July 16, 2015
    Report Date
    July 16, 2015
    Manufacturer
    MAQUET CARDIOPULMONARY AG
    Product Code
    DTZ
    PMA / PMN Number
    K082117
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    MAQUET CARDIOPULMONARY AG REQUESTED THE PRODUCT BACK FOR INVESTIGATION. PRODUCT WAS RECEIVED ON 08/11/2015. INVESTIGATION IS STILL PENDING. A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED AS SOON AS FURTHER INFO BECOMES AVAILABLE. ABBREVIATIONS: ECMO = EXTRACORPOREAL MEMBRANE OXYGENATION. ACT = ACTIVATED CLOTTING TIME. ICU = INTENSIVE CARE UNIT. THE PRODUCT MENTIONED IS A TUBING SET AND THE INCLUDED AFFECTED COMPONENT HAS THE CONTRIBUTING DESIGN FUNCTION OF THE QUADROX-I WHICH IS REGISTERED UNDER 510 (K): K082117.

    Additional Manufacturer Narrative · 1

    THE OXYGENATOR WAS TESTED FOR ITS PRESSURE DROP PERFORMANCE. THEREBY A PRESSURE DROP DURING MAXIMUM FLOW AT A BLOOD-GAS-RATIO 1:1 MAX. 100 MMHG WAS PERFORMED. FURTHERMORE A BLOOD FLOW OF 7 1/MIN WAS SUSTAINED FOR 10 MORE MINUTES. DURING THIS TIME THE PRESSURE RATIO WAS CONSTANTLY. OXYGENATOR PASSED SUCCESSFULLY THE PRESSURE TESTING. THEREFORE THE REPORTED FAILURE COULD NOT BE CONFIRMED. FOR FURTHER INVESTIGATION A DHR WAS PERFORMED BY THE MANUFACTURER. THEREBY OXYGENATOR PASSED ALL PRODUCTION STEPS AND WAS NOT MARKED AS SCRAP. THE CAUSE OF THIS FAILURE WAS DETERMINED TO NOT BE ATTRIBUTED TO A DEVICE RELATED MALFUNCTION. THE DATA IS ALSO BEING HANDLED THROUGH A DESIGNATED MAQUET TRENDING PROCESS. IF A TREND OCCURS, IT WILL BE ESCALATED TO QUALITY ASSURANCE MANAGEMENT FOR REVIEW AND DETERMINATION OF APPLICABLE INVESTIGATION. DUE TO THIS NO FURTHER ACTION WILL BE COMPLETED AT THIS TIME.

    Additional Manufacturer Narrative · 1

    PRODUCT WAS RECEIVED FOR MANUFACTURERS INVESTIGATION. OXYGENATOR WAS CLEANED AND DISINFECTED. A VISUAL INSPECTION WAS PERFORMED. THEREBY A SMALL NUMBER OF CLOTS WAS NOTICED. BUT THESE CLOTS COULD ONLY BE REMOVED WITH SODIUM HYPOCHLORITE. OXYGENATOR WAS FORWARDED FOR FURTHER INVESTIGATION TO THE QA-LABORATORY. A DEVICE HISTORY RECORD WAS PERFORMED BY THE MANUFACTURER ON 09/11/2015. THE COMPLAINED OXYGENATOR PASSED ALL PRODUCTION STEPS AND WAS NOT MARKED AS SCRAP. INVESTIGATION IS STILL PENDING. A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED AS SOON AS FURTHER INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    DESCRIPTION FROM THE CUSTOMER REPORT: "AFTER ABOUT 3HRS LATER FROM THE BEGINNING OPERATION, BIG PRESSURE DIFFERENCE BETWEEN BEFORE AND AFTER-OXYGENATOR LIKE OXYGENATOR SEEMS TO BE CLOGGED. SO REPLACED WITH A NEW OXYGENATOR. BUT THE PT IS NOT GOOD. PERFUSIONIST SAY THAT CLOG BY BLOOD IS VERY LOW BECAUSE OF ACT VALUE IS NO HIGH." ADDITIONAL INFO: PT DIED ABOUT 15HRS LATER AFTER TRANSFERRING TO ICU. EXCEPT OF OLD AGE, NO SPECIAL CLINICAL CONDITION ACCORDING TO SURGEON AND PERFUSIONIST IN CHARGE. CLOTTING WAS NOTICED NEARBY BLOOD INLET. BETWEEN THE FIRST OXYGENATOR AND THE SECOND ONE FOR REPLACEMENT, THERE WERE ABOUT 15MINUTES GAP AND ECMO WAS APPLIED TO PT FOR THAT PERIOD. ACCORDING TO THE VALUES OF DELTA P PERFUSIONIST STATED THAT THERE WAS NO RECORD BECAUSE THEY DIDN'T WRITE DOWN IN REAL TIME. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFO RECEIVED ON (B)(6) 2015: "ACCORDING TO PERFUSIONIST IN PERSON, THEY DO NOT USE A DEVICE TO MEASURE ACT VALUE DURING OPERATION. THEY HAVE THEIR OWN METHOD TO CHECK(FEEL) THIS VALUE. BUT NO EXACT NUMERICAL VALUE WITH THEM. ACCORDING TO THEIR USUAL METHOD, THEY DID FIGURE OUT ACT WAS HIGH."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    536126 HLM TUBING SET W/ SOFTLINE COATING DTZ MAQUET CARDIOPULMONARY AG VKMO 70000 92161845

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Death| R