BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VASOVIEW HEMOPRO

    MDR report key: 8776759 · Received July 10, 2019

    Report

    Report Number
    2242352-2019-00752
    Event Type
    Malfunction
    Date Received
    July 10, 2019
    Date of Event
    June 11, 2019
    Report Date
    July 8, 2019
    Manufacturer
    MAQUET CARDIOVASCULAR LLC
    Product Code
    GEI
    PMA / PMN Number
    K052274
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THE BTT WAS RETURNED TO THE FACTORY FOR EVALUATION. PHOTOGRAPHS WERE PROVIDED BY THE ACCOUNT. THE BALLOON WAS OBSERVED TO BE PARTIALLY INFLATED. AN INVESTIGATION WAS CONDUCTED ON (B)(6) 2019. A VISUAL INSPECTION WAS CONDUCTED. NO VISIBLE DEFECTS WERE OBSERVED ON THE BALLOON OR THE BTT. THERE WAS NO OBSERVED FAILURES WITH THE BTT SHORT PORT.AN INFLATION TEST WAS CONDUCTED. THE BALLOON WAS INFLATED AND SUBMERGED IN PLAIN WATER TO OBSERVE THE PRESENCE OF BUBBLES. THE DEVICE FAILED THE INFLATION TEST, IT BECAME DEFLATED, HOWEVER THERE WERE NO BUBBLES WERE OBSERVED UNDER SUBMERSION. WE ARE UNABLE TO DETERMINE WHERE THE LEAK OCCURRED. BASED ON THE RETURN CONDITION OF THE DEVICE, THE REPORTED FAILURE "LEAK" WAS CONFIRMED. THE DHR, SHOP FLOOR PAPERWORK 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, VASOVIEW HEMOPRO BTT'S AIRBAG IS LEAKING AND CANNOT BE USED NORMALLY. A REPLACEMENT DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE HOSPITAL DID NOT REPORT ANY PATIENT EFFECTS.

    Additional Manufacturer Narrative · 1

    (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. DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT DURING AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, VASOVIEW HEMOPRO BTT'S AIRBAG IS LEAKING AND CANNOT BE USED NORMALLY. 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
    572088 VASOVIEW HEMOPRO ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI MAQUET CARDIOVASCULAR LLC VASOVIEWHEMPRO (OUS) VH-3000 25142173

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR