BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HQV 32902#INTEGRATED ADULT PACK

    MDR report key: 4865038 · Received June 22, 2015

    Report

    Report Number
    8010762-2015-00741
    Event Type
    Malfunction
    Date Received
    June 22, 2015
    Date of Event
    May 26, 2015
    Report Date
    June 9, 2015
    Manufacturer
    MAQUET CARDIOPULMONARY AG
    Product Code
    DWE
    PMA / PMN Number
    K001787
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    MAQUET CARDIOPULMONARY AG PROVIDES PRODUCT FAILURE INVESTIGATION, ANALYSIS AND RESOLUTION FOR THE DEVICE DESCRIBED IN THIS REPORT. DURING PRIMING, A LEAK WAS NOTICED COMING FROM THE QUART AROUND THE EDGE OF FRONT PLATE. TIGHTNESS TESTS HAS BEEN PERFORMED WITH FORMER COMPLAINT PRODUCTS AND THE LEAKAGE BETWEEN HOUSING AND COVER CAN BE CONFIRMED. THE MOST PROBABLE ROUTE-CAUSE: BAD GLUE CONNECTION AT THE HOUSING. 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.

    Additional Manufacturer Narrative · 1

    MAQUET CARDIOPULMONARY (B)(4) IS AWARE OF SIMILAR COMPLAINTS FROM THIS PRODUCT. SIMILAR PRODUCTS, SHOWING A SIMILAR MALFUNCTION, HAVE BEEN TESTED. A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED AS SOON AS ADDITIONAL INFO BECOMES AVAILABLE. COMPONENT: 00175#QUART. COMPONENT ARTICLE NO 70000.0175. COMPONENT LOT NO 70101435. K082544 (510K#).

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT "DURING PRIMING A LEAKING AROUND EDGE OF FRONT PLATE HAS BEEN DETECTED. THE WHOLE SET HAD TO BE CHANGED OUT PRIOR TO BYPASS. NO PT INJURY WAS REPORTED." (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    403253 HQV 32902#INTEGRATED ADULT PACK DWE MAQUET CARDIOPULMONARY AG 00175#@QUART 92156778

    Patients

    Seq Age Sex Outcome Treatment
    1