BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ABVISER-INTRA ABD PRESSURE MONITOR DEVICE

    MDR report key: 3982689 · Received July 24, 2014

    Report

    Report Number
    1049092-2014-00345
    Event Type
    Malfunction
    Date Received
    July 24, 2014
    Date of Event
    July 5, 2014
    Report Date
    July 7, 2014
    Manufacturer
    CONVATEC INC
    Product Code
    FEN
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE AVAILABLE INFORMATION, THIS EVENT IS DEEMED A REPORTABLE MALFUNCTION. THERE WERE NO REPORTS OF THE PATIENT BEING HARMED AS A RESULT OF THIS MALFUNCTION. NO ADDITIONAL PATIENT/EVENT DETAILS HAVE BEEN PROVIDED TO DATE. A RETURN SAMPLE FOR EVALUATION IS NOT EXPECTED. SHOULD ADDITIONAL INFORMATION BECOMES AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. ADDITIONAL QUALITY EVALUATION PERFORMED ON (B)(4) 2014 STATES THAT THERE WERE (B)(4) REPORTS NOTED IN RECORDS FOR URINE RETENTION, ONE OF WHICH WAS WITHIN THE PAST YEAR.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE ABVISER DEVICE WAS INSTALLED TO MONITOR IAP (INTRA ABDOMINAL PRESSURE) AND CONNECTED TO A #14 FOLEY CATHETER AND URINE COLLECTING BAG CISTOFLO. THE IAP (INTRA ABDOMINAL PRESSURE) MEASUREMENT WAS PERFORMED FOR A DAY, HOWEVER, IN THE MEASUREMENT WAS PERFORMED FOR A DAY, HOWEVER IN THE MEASUREMENT OF THE SECOND DAY AT NIGHT THE VALVE SYSTEM DID NOT DEFLATE AND COLLAPSE URINE OUTPUT FOR FOUR (4) HOURS RESULTING IN THE REMOVAL OF THE DEVICE TWENTY FOUR (24) HOURS OF USE. IT IS FURTHER REPORTED THAT THE OBSTRUCTION IN URINE IS ASSOCIATED WITH THE DEVICE BEING IN PLACE; THEREFORE IT WAS DECIDED TO REMOVE THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    435263 ABVISER-INTRA ABD PRESSURE MONITOR DEVICE DEVICE, CYSTOMETRIC, HYDRAULIC FEN CONVATEC INC ABV300 131038

    Patients

    Seq Age Sex Outcome Treatment
    1