BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACROBAT SUV VACUUM STABILIZER SYSTEM, ST

    MDR report key: 3111614 · Received May 6, 2013

    Report

    Report Number
    2242352-2013-00424
    Event Type
    Malfunction
    Date Received
    May 6, 2013
    Date of Event
    March 27, 2013
    Report Date
    April 16, 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
    CT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT YET BEEN RETURNED TO MAQUET CARDIAC SURGERY FOR EVALUATION. 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 WAS COMPLETED FOR THE REPORTED PRODUCT LOT NUMBER. THERE WAS NO NONCONFORMANCE RECORDED IN THE LOT HISTORY. (B)(4).

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT DURING A CORONARY ARTERY BYPASS PROCEDURE, THE SUCTION ON THE ACROBAT SUV VACUUM STABILIZER SYSTEM WAS NOT WORKING PROPERLY. A REPLACEMENT DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE HOSPITAL DID NOT REPORT ANY PATIENT EFFECTS. THE HOSPITAL INTENDS TO RETURN THE PRODUCT IN QUESTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    197502 ACROBAT SUV VACUUM STABILIZER SYSTEM, ST CLAMPLESS BEATING HEART DXC MAQUET CARDIOVASCULAR, LLC OM-9000S 25071056

    Patients

    Seq Age Sex Outcome Treatment
    1 NA