BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VASO VIEW HEMOPRO

    MDR report key: 3983298 · Received July 3, 2014

    Report

    Report Number
    2242352-2014-00740
    Event Type
    Malfunction
    Date Received
    July 3, 2014
    Date of Event
    June 6, 2014
    Report Date
    June 9, 2014
    Manufacturer
    MAQUET CARDIOVASCULAR, LLC
    Product Code
    GEI
    PMA / PMN Number
    K052274
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    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. A LOT HISTORY RECORD REVIEW WAS COMPLETED FOR THE REPORTED PRODUCT LOT NUMBER. THERE WAS NO NONCONFORMANCE RECORDED IN THE LOT HISTORY. THERE ARE NO OTHER SIMILAR COMPLAINTS REPORTED AGAINST THIS BATCH. INTERNAL COMPLAINT NUMBER - (B)(4).

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT DURING AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, THE BTT BALLOON WOULD NOT HOLD AIR PRESSURE ON THE VASO HEMOPRO. IT APPEARED THAT THE VALVE WAS NOT WORKING PROPERLY. 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
    392001 VASO VIEW HEMOPRO ENDOSCOIC VESSEL HARVESTING GEI MAQUET CARDIOVASCULAR, LLC VH-3000 25096751

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR