BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XPOSE 4 DEVICE

    MDR report key: 2201706 · Received August 4, 2011

    Report

    Report Number
    2242352-2011-01073
    Event Type
    Malfunction
    Date Received
    August 4, 2011
    Date of Event
    July 18, 2011
    Report Date
    July 19, 2011
    Manufacturer
    MAQUET CARDIOVASCULAR, LLC
    Product Code
    DXC
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    SINCE THE DEVICE IS NOT AVAILABLE TO BE RETURNED TO USE, A TECHNICAL EVALUATION CAN NOT BE PERFORMED. WE WILL, HOWEVER, CONTINUE TO MONITOR AND TREND THIS TYPE OF EVENT TO ENSURE THAT THERE IS NO COMPROMISE TO QUALITY. A LOT HISTORY RECORD REVIEW WAS COMPLETED FOR THE REPORTED PRODUCT LOT NUMBER. THERE WERE NO NON CONFORMANCE ISSUE(S) WITH THIS PRODUCT LOT. INTERNAL FILE NUMBER - (B)(4).

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT DURING A CORONARY ARTERY BYPASS PROCEDURE, THE XPOSE 4 DID NOT MAINTAIN SUCTION. REPORTED STATED THAT "THE HEART KEPT FALLING". THEY DID TEST THE VACUUM SYSTEM. THE REPORTED KIT WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PT EFFECTS. THE PRODUCT WAS DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XPOSE 4 DEVICE CLAMPLESS BEATING HEART DXC MAQUET CARDIOVASCULAR, LLC C-XP-4000 25037447

    Patients

    Seq Age Sex Outcome Treatment
    1 NA