BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VASOVIEW HEMOPRO 2

    MDR report key: 3943787 · Received April 30, 2014

    Report

    Report Number
    2242352-2014-00489
    Event Type
    Malfunction
    Date Received
    April 30, 2014
    Date of Event
    April 3, 2014
    Report Date
    April 3, 2014
    Manufacturer
    MAQUET CARDIOVASCULAR LLC
    Product Code
    GEI
    PMA / PMN Number
    K101274
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO THE FACTORY FOR EVAL. IT SHOWED SIGNS OF CLINICAL USAGE AND EVIDENCE OF BLOOD. A VISUAL INSPECTION DETERMINED THAT THE HEATER WIRE WAS DETACHED FROM THE TIP OF THE HOT JAW. THERE WAS A TEAR OBSERVED ON THE TIP OF THE HOT JAW, THIS PROBLEM IS CONSISTENT WITH THE IMPROPER INSERTION OF THE TOOL INTO THE CANNULA. A PRE-CAUTERY TEST WAS PERFORMED ON THE DEVICE WITH A REFERENCE POWER SUPPLY, EXTENSION AND ADAPTER CABLE. THE DEVICE PASSED THE PRE-CAUTERY TEST; IT PRODUCED STEAM AND HEAT DURING SEVERAL ACTIVATIONS AND SHUT OFF WHEN THE TOGGLE WAS RELEASED. A POLYFUSE ELECTRICAL TEST WAS PERFORMED WITH A REFERENCE POWER SUPPLY, ADAPTER CABLE AND EXTENSION; THE POLYFUSE SUCCESSFULLY SHUT OFF POWER TO THE HEATER AFTER PROLONGED PERIODS OF TIME AND ACTIVATE 30 SECONDS COOL DOWN. BASED UPON THE EVAL RESULTS, THE REPORTED COMPLAINT COULD NOT BE CONFIRMED. A LOT HISTORY RECORD REVIEW WAS COMPLETED FOR THE REPORTED PRODUCT LOT NUMBER. THERE WAS NO NON CONFORMANCE RECORDED IN THE LOT HISTORY. (B)(4).

    Description of Event or Problem · 1

    THE HOSP REPORTED THAT DURING AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, THE VASOVIEW HEMOPRO 2 WAS WORKING PROPERLY FOR APPROX TWENTY MINUTES AND THEN STOPPED ACTIVATING. THEY CHANGED OUT SOME CABLES, BUT NOTHING WORKED. 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
    258357 VASOVIEW HEMOPRO 2 ENDOSCOPIC VESSEL HARVESTING GEI MAQUET CARDIOVASCULAR LLC VH-4000 25093641

    Patients

    Seq Age Sex Outcome Treatment
    1