BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VASOVIEW HEMOPRO 2

    MDR report key: 3021010 · Received March 20, 2013

    Report

    Report Number
    2242352-2013-00255
    Event Type
    Malfunction
    Date Received
    March 20, 2013
    Date of Event
    February 22, 2013
    Report Date
    February 25, 2013
    Manufacturer
    MAQUET CARDIOVASCULAR, LLC
    Product Code
    GEI
    PMA / PMN Number
    K101274
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION RESULTS: THE DEVICE WAS RETURNED TO THE FACTORY FOR EVALUATION. IT SHOWED SIGNS OF CLINICAL USAGE OR EVIDENCE OF BLOOD. THE HEMOPRO 2 DEVICE WAS RETURNED INSIDE OF THE CANNULA. A VISUAL INSPECTION DETERMINED THAT THE HEATER WIRE WAS SEPARATED FROM THE CENTER OF THE HOT JAW. THE HEATER WIRE REMAINED ATTACHED TO THE TIP OF THE JAW. THE JAWS WERE BENT AT 45 DEGREE ANGLE AT THE END OF THE SHAFT. THE HEMOPRO 2 TOOL CANNOT PHYSICALLY BE INSERTED INTO THE CANNULA WITH THE JAWS BENT AT A 45 DEGREE ANGLE; THUS THE REPORTED INCIDENT APPEARS TO HAVE OCCURRED AFTER INSERTION OF THE TOOL INTO THE CANNULA. BASED UPON THE EVALUATION RESULTS, 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 HOSP REPORTED THAT DURING PREPARATION FOR AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, THE JAWS ON THE HEMOPRO 2 WERE BENT UPON OPENING THE PACKAGE. A REPLACEMENT DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE HOSP DID NOT REPORT ANY PT EFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    115803 VASOVIEW HEMOPRO 2 ENDOSCOPIC VESSEL HARVESTING GEI MAQUET CARDIOVASCULAR, LLC VH-4000 25063857

    Patients

    Seq Age Sex Outcome Treatment
    1 NA