BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BETTER-BLADDER

    MDR report key: 5844349 · Received August 3, 2016

    Report

    Report Number
    1000522036-2016-00001
    Event Type
    Malfunction
    Date Received
    August 3, 2016
    Date of Event
    August 7, 2015
    Report Date
    July 26, 2016
    Manufacturer
    CIRCULATORY TECHNOLOGY INC.
    Product Code
    DTN
    PMA / PMN Number
    K981284
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CTI COULD NOT OBTAIN THE LOT NUMBER OF THE DEVICE OR THE NAME OF THE FACILITY REPORTING THE ISSUE FROM FDA DUE TO FOIA RESTRICTIONS. ADDITIONALLY, CTI COULD NOT OBTAIN THE DEVICE FOR EVALUATION. THE ISSUE DESCRIBED IN THE MEDWATCH REPORT DESCRIBES AIR ENTERING THE HOUSING OF A BB14 DEVICE. SINCE BONE WAX APPLIED TO THE HOUSING-BALLOON JOINT ELIMINATED THE AIR ENTERING THE HOUSING, IT IS LOGICAL TO SURMISE THAT IF A LEAK WERE PRESENT, ITS LOCATION WOULD BE THE HOUSING-BALLOON JOINT. THE ISSUE OCCURRED ON DAY 7 OF ECMO AS PER THE MEDWATCH REPORT. DUE TO THE 7 DAYS OF PROPER OPERATION OF THE BB14 DEVICE, IT IS AGAIN LOGICAL TO SURMISE THAT THE DEVICE WAS INITIALLY NOT LEAKING. WITHOUT THE INFORMATION REQUESTED BY CTI OR AVAILABILITY OF THE ACTUAL UNIT, IT IS NOT POSSIBLE TO PERFORM AN ACTUAL DIAGNOSIS OF THE PURPORTED SITUATION. IT SHOULD BE NOTED THAT SINCE THE BB14 WAS INTRODUCED IN 1997, CTI HAS NOT RECEIVED ANY OTHER REPORTS OF THIS ISSUE WITH THE BB14 DEVICE.

    Description of Event or Problem · 1

    ACCORDING TO THE DESCRIPTION PROVIDED TO CTI BY FDA - "BLADDER DECOMPRESSION WAS NOTED DURING DAY 7 OF PEDIATRIC ECMO RUN. AIR WAS REMOVED FROM THE [HOUSING OF THE] BLADDER. PATIENT WAS REPOSITIONED AND VOLUME ADMINISTERED. HOWEVER, CONTINUED DECOMPRESSION [OF THE BLADDER] WAS OBSERVED. UPON CLOSER INSPECTION, AN AIR LEAK WAS DISCOVERED AT THE BOTTOM CASING WHERE THE TUBING MEETS THE HARD PLASTIC CASING. BONE WAX PLACED OVER THE AREA AND THE ISSUE WAS TEMPORARILY RESOLVED. THE BETTER-BLADDER WAS SUBSEQUENTLY REPLACED IN THE CIRCUIT." BRACKETS INDICATE ADDITIONS BY CIRCULATORY TECHNOLOGY INC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    497945 BETTER-BLADDER BETTER-BLADDER, BB14 DTN CIRCULATORY TECHNOLOGY INC. BB14

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention