BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACROBAT SUV VACUUM STABILIZER SYSTEM, ST

    MDR report key: 2180743 · Received April 29, 2011

    Report

    Report Number
    2242352-2011-00373
    Event Type
    Malfunction
    Date Received
    April 29, 2011
    Date of Event
    March 24, 2011
    Report Date
    April 5, 2011
    Manufacturer
    MAQUET CARDIOVASCULAR, LLC
    Product Code
    GEI
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION: VISUAL INSPECTION REVEALED THAT THE LOGO PLATE BROKE INTO TWO PIECES. THE SMALLER BROKEN PIECE WAS PART OF THE PLUNGER HOUSING CAP AND THE STOP PLATE. THE LOGO WAS RECEIVED ATTACHED TO THE STABILIZER BUT CAN BE EASILY REMOVED. THE STABILIZER TUBING HAD BEEN CUT OFF AND WAS NOT RETURNED. THERE WAS NO EVIDENCE OF BLOOD ON THE DEVICE. BASED UPON THE RECEIVED CONDITION OF THE DEVICE, THE REPORTED COMPLAINT "LOGO DETACHED AND BROKE OFF INTO SMALL FRAGMENTS" WAS CONFIRMED. A LOT HISTORY RECORD REVIEW WAS COMPLETED FOR THE REPORTED PRODUCT LOT NUMBER. THERE WAS NO NONCONFORMANCE WHICH COULD HAVE CONTRIBUTED TO THIS FAILURE MODE. (B)(4).

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT DURING A CORONARY ARTERY BYPASS PROCEDURE, THE ACROBAT SUV STABILIZER LOGO DETACHED AND BROKE OFF INTO SMALL FRAGMENTS. THE PER STATED "THE PARTS OF THE MAQUET LOGO CAME OFF DURING USE AND BROKE INTO SMALL FRAGMENTS. OPERATION STOPPED 10 MINUTES TO FIND THE FRAGMENTS, AND FOUND NEAR THE PATIENT HEAD." A REPLACEMENT UNIT WAS USED TO COMPLETE THE PROCEDURE. THE HOSPITAL DID NOT REPORT ANY PATIENT EFFECTS. THE PRODUCT WAS RETURNED. UPON RECEIPT OF THE PRODUCT, IT WAS OBSERVED THAT THE MAQUET LOGO HAD DETACHED AND BROKE OFF INTO TWO PIECES, BOTH OF WHICH WERE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACROBAT SUV VACUUM STABILIZER SYSTEM, ST ACROBAT SUV GEI MAQUET CARDIOVASCULAR, LLC OM-9000S 25017913

    Patients

    Seq Age Sex Outcome Treatment
    1 NA