BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VASOVIEW HEMOPRO 2

    MDR report key: 3124010 · Received May 15, 2013

    Report

    Report Number
    2242352-2013-00467
    Event Type
    Malfunction
    Date Received
    May 15, 2013
    Date of Event
    April 25, 2013
    Report Date
    April 25, 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
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO THE FACTORY FOR EVAL. IT SHOWED SIGNS OF CLINICAL USAGE AND NO EVIDENCE OF BLOOD. A VISUAL INSPECTION DETERMINED THAT THE HEATER WIRE WAS BENT AND DETACHED FROM THE TIP OF THE HOT JAW. BASED UPON THE RECEIVED CONDITION OF THE DEVICE, THE REPORTED COMPLAINT WAS CONFIRMED. 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 HEMOPRO 2 HEATER WIRE BECAME LOOSE. 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    214843 VASOVIEW HEMOPRO 2 ENDOSCOPIC VESSEL HARVESTING GEI MAQUET CARDIOVASCULAR, LLC VH-4000 25065076

    Patients

    Seq Age Sex Outcome Treatment
    1 NA