BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VASOVIEW HEMOPRO 2

    MDR report key: 2945479 · Received February 1, 2013

    Report

    Report Number
    2242352-2013-00040
    Event Type
    Malfunction
    Date Received
    February 1, 2013
    Date of Event
    January 10, 2013
    Report Date
    January 10, 2013
    Manufacturer
    MAQUET CARDIOVASCULAR, LLC.
    Product Code
    GEI
    PMA / PMN Number
    K101274
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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 AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, THE HEATER WIRE ON TWO HEMOPRO 2 DEVICES DETACHED. NOTHING FELL INTO THE PT AND NO INTERVENTION WAS REQUIRED. A REPLACEMENT DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE HOSPITAL DID NOT REPORT ANY PT EFFECTS. THE HOSPITAL INTENDS TO RETURN THE PRODUCT IN QUESTION. REFER TO MFR REPORT #2242352-2013-00119 FOR THE RELATED REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    43780 VASOVIEW HEMOPRO 2 ENDOSCOPIC VESSEL HARVESTING GEI MAQUET CARDIOVASCULAR, LLC. VH-4000 25066106

    Patients

    Seq Age Sex Outcome Treatment
    1 NA