BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VASOVIEW HEMOPRO 2

    MDR report key: 3810948 · Received March 23, 2014

    Report

    Report Number
    2242352-2014-00321
    Event Type
    Malfunction
    Date Received
    March 23, 2014
    Date of Event
    February 27, 2014
    Report Date
    February 27, 2014
    Manufacturer
    MAQUET CARDIOVASCULAR, LLC
    Product Code
    GEI
    PMA / PMN Number
    K101274
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO THE FACTORY FOR EVALUATION. IT SHOWED SIGNS OF CLINICAL USAGE AND EVIDENCE OF BLOOD. A VISUAL INSPECTION DID NOT IDENTIFY ANY NON-CONFORMITIES. THE BTT BALLOON WAS INFLATED WITH 25 CC OF AIR THROUGH THE BALLOON INFLATION PORT AND SUBMERGED IN WATER; NO LEAKAGE WAS OBSERVED. THE CO2 INSUFFLATION PORT WAS TESTED; AIR WOULD NOT FLOW THROUGH. ADHESIVE WAS OBSERVED IN THE INSUFFLATION OPENING ON THE BODY. WHILE WE ARE UNABLE TO CONCLUSIVELY DETERMINE A ROOT CAUSE, EACH BTT INSUFFLATION TUBE GETS TESTED PRIOR TO DISTRIBUTION. ADDITIONAL EVALUATION REQUIRED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETED. A LOT HISTORY RECORD REVIEW WAS COMPLETED FOR THE REPORTED PRODUCT NUMBER. THERE WAS NO NON-CONFORMANCE RECORDED IN THE LOT HISTORY. (B)(4).

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT DURING AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, THERE WAS NO INFLATION GOING THROUGH THE VASOVIEW HEMOPRO 2 BTT SHORT PORT. THE HOSPITAL DID NOT REPORT ANY PATIENT EFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    171324 VASOVIEW HEMOPRO 2 ENDOSCOPIC VESSEL HARVESTING GEI MAQUET CARDIOVASCULAR, LLC VH-4000 NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NI