BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VASOVIEW HEMOPRO 2

    MDR report key: 10065081 · Received May 18, 2020

    Report

    Report Number
    2242352-2020-00430
    Event Type
    Malfunction
    Date Received
    May 18, 2020
    Date of Event
    April 27, 2020
    Report Date
    May 18, 2020
    Manufacturer
    MAQUET CARDIOVASCULAR LLC
    Product Code
    GEI
    PMA / PMN Number
    K101274
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INTERNAL COMPLAINT NUMBER: (B)(4). THE DEVICE WAS RETURNED TO THE FACTORY ON (B)(6) 2020. AN INVESTIGATION WAS CONDUCTED ON (B)(6) 2020. A VISUAL INSPECTION WAS CONDUCTED. SIGNS OF CLINICAL USE AND EVIDENCE OF BLOOD WAS OBSERVED ON THE BTT. THE INSUFFLATION TUBE WAS OBSERVED TO BE INTACT, NO VISUAL DEFECTS WERE OBSERVED. THE BALLOON OF THE BTT WAS OBSERVED TO BE INTACT, NO VISUAL DEFECTS WERE OBSERVED. THE CLEAR PORT WAS OBSERVED TO BE DETACHED FROM THE BTT AND WAS RETURNED FOR EVALUATION. AN INFLATION TEST WAS UNABLE TO BE CONDUCTED DUE TO THE DETACHED PORT. BASED ON THE RETURNED CONDITION OF THE DEVICE, THE REPORTED FAILURE "BREAK" WAS CONFIRMED. THE CERTIFICATE OF CONFORMANCE (C OF C) WAS REVIEWED. THE VENDOR CERTIFIES THAT THIS DEVICE LOT CONFORMS TO ALL APPLICABLE PRODUCT SPECIFICATIONS.

    Description of Event or Problem · 0

    THE HOSPITAL REPORTED THAT DURING AN ENDOSCOPIC VEIN HARVESTING PROCEDURE USING VASOVIEW HEMOPRO 2, THE AIR INLET FOR THE BTT PORT BALLOON WAS BROKEN. A REPLACEMENT DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE HOSPITAL DID NOT REPORT ANY PATIENT EFFECTS.

    Additional Manufacturer Narrative · 1

    TRACKWISE ID # (B)(4). A LOT HISTORY RECORD REVIEW WAS COMPLETED FOR THE REPORTED PRODUCT LOT NUMBER. THERE WERE NO NCMR¿S FOR THE REPORTED LOT NUMBER. 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.

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT DURING AN ENDOSCOPIC VEIN HARVESTING PROCEDURE USING VASOVIEW HEMOPRO 2, THE AIR INLET FOR THE BTT PORT BALLOON WAS BROKEN. A REPLACEMENT DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE HOSPITAL DID NOT REPORT ANY PATIENT EFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    531570 VASOVIEW HEMOPRO 2 ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI MAQUET CARDIOVASCULAR LLC VASOVIEW HEMOPRO 2 25146844

    Patients

    Seq Age Sex Outcome Treatment
    1