BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIGGER BETTER-BLADDER

    MDR report key: 8934600 · Received August 27, 2019

    Report

    Report Number
    8934600
    Event Type
    Malfunction
    Date Received
    August 27, 2019
    Date of Event
    January 3, 2019
    Report Date
    August 20, 2019
    Manufacturer
    CIRCULATORY TECHNOLOGY INC
    Product Code
    DTN
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    THE BIGGER BETTER BLADDER IN THE ECMO CIRCUIT HAS AN AIR CHAMBER ON THE OUTSIDE FOR EQUILIBRATING THE PRESSURES DURING THE RUN THAT ENSURES APPROPRIATE NEGATIVE PRESSURE ON THE SYSTEM. DURING THE PREVIOUS NIGHT, SPECIALIST HAS TROUBLE MAINTAINING THE AIR CHAMBER TO THE RIGHT PRESSURE. WE FOUND THE AIR CHAMBER PIGTAIL CONNECTOR WAS LEAKING, REQUIRING THE BLADDER TO BE CHANGED ON THE CIRCUIT. THE PATIENT WAS OFF BYPASS FOR 1 MINUTE AND 20 SECONDS DURING THE CHANGE, BUT TOLERATED THE BRIEF TIME OFF WITHOUT INCIDENT. POSSIBLY A MANUFACTURER DEFECT. EVENT WAS RELATED TO A DEFECTIVE CONSUMABLE WHICH WAS REPLACED WITH NO EVENT. MACHINE DID NOT MALFUNCTION; NO FURTHER ACTION REQUIRED BY BIOMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    727749 BIGGER BETTER-BLADDER RESERVOIR, BLOOD, CARDIOPULMONARY BYPASS DTN CIRCULATORY TECHNOLOGY INC BBB38 5300-S19955

    Patients

    Seq Age Sex Outcome Treatment
    1 8395 DA