BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HLM TUBING SET W/SOFTLINE COATING

    MDR report key: 4930967 · Received July 20, 2015

    Report

    Report Number
    8010762-2015-00827
    Event Type
    Injury
    Date Received
    July 20, 2015
    Date of Event
    June 16, 2015
    Report Date
    June 23, 2015
    Manufacturer
    MAQUET CARDIOPULMONARY AG
    Product Code
    DWF
    PMA / PMN Number
    K090533
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT AVAILABLE FOR INVESTIGATION AND ALSO NO PICTURES OF THE LEAKAGE WERE AVAILABLE. THEREFORE THE REPORTED PROBLEM COULD NOT BE DUPLICATED. THE DATA IS ALSO BEING HANDLED THROUGH A DESIGNATED MAQUET CARDIOPULMONARY TRENDING AND APPLICABLE INVESTIGATION PROCESS. DUE TO THIS NO FURTHER INVESTIGATION INITIATIONS WILL BE COMPLETED AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A VALVULO AORTIC REPLACEMENT AND AN AORTO-CORONARIAN BYPASS, THE NURSE NOTICED AT THE END OF OPERATION A LEAKAGE AT THE CAP AIR INTAKE ON THE FILLING LINE OF CEC CIRCUIT. NO CLINICAL CONSEQUENCE WAS REPORTED, THE CUSTOMER PRECISED THAT THE BLOOD LEAKAGE WAS MINIMAL. REF.: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    468843 HLM TUBING SET W/SOFTLINE COATING DWF MAQUET CARDIOPULMONARY AG BO-HQV 39600 92165856

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Other