BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACROBAT SUV OFF PUMP SYS, W/XP4000 STD

    MDR report key: 3001717 · Received March 11, 2013

    Report

    Report Number
    2242352-2013-00222
    Event Type
    Malfunction
    Date Received
    March 11, 2013
    Date of Event
    February 15, 2013
    Report Date
    February 15, 2013
    Manufacturer
    MAQUET CARDIOVASCULAR, LLC
    Product Code
    DXC
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT YET BEEN RETURNED TO MAQUET CARDIAC SURGERY FOR EVAL. WE ARE FOLLOWING UP WITH THE CUSTOMER FOR THE RETURN OF THE DEVICE. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF THE DEVICE IS RECEIVED. A LOT HISTORY RECORD REVIEW COULD NOT BE PERFORMED AS THE PRODUCT LOT NUMBER IS UNK. (B)(4).

    Description of Event or Problem · 1

    THE HOSP REPORTED THAT DURING A CORONARY ARTERY BYPASS PROCEDURE, THE ACROBAT SUV OFF PUMP SYSTEM WITH THE XPOSE 4 DEVICE FAILED TO SUCTION PROPERLY. A REPLACEMENT DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE HOSP DID NOT REPORT ANY PT EFFECTS. THE HOSP INTENDS TO RETURN THE PRODUCT IN QUESTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    102102 ACROBAT SUV OFF PUMP SYS, W/XP4000 STD CLAMPLESS BEATING HEART DXC MAQUET CARDIOVASCULAR, LLC XO4-9000S ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1