BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIGGER BETTER BLADDER

    MDR report key: 9354816 · Received November 21, 2019

    Report

    Report Number
    1000522036-2019-00001
    Event Type
    Malfunction
    Date Received
    November 21, 2019
    Date of Event
    January 1, 2019
    Report Date
    October 3, 2019
    Manufacturer
    CIRCULATORY TECHNOLOGY INC
    Product Code
    DTN
    UDI-DI
    00851997007011
    PMA / PMN Number
    K98124
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE USER STATES THAT THE BIGGER BETTER-BLADDER FAILED DUE TO A LEAKING PIGTAIL THE UNIT WAS NOT RETURNED FOR INSPECTION AND CONFIRMATION. THIS IS THE FIRST AND ONLY COMPLAINT RECEIVED FOR A LEAKING PIGTAIL SINCE IMPLEMENTATION OF A CORRECTIVE ACTION ON 10/6/2017. EACH UNIT IS TESTED DURING THE MANUFACTURING PROCESS AND NO ISSUES WERE REPORTED. A REVIEW OF THE OHR FOUND NO EVIDENCE OF NONCONFORMITIES WITH NO REPORTED DEFECTS. SINCE IMPLEMENTATION OF THE CORRECTIVE ACTION ON 10/6/17, THIS IS THE ONLY REPORT OF A LEAKING PIGTAIL. SPECIFICALLY, (B)(4) LOTS OF BETTER-BLADDERS AND BIGGER BETTER-BLADDERS HAVE BEEN MANUFACTURED WITH THIS COMPLAINT RESULTING IN A DEFECT RATE OF (B)(4). THE LEAKING PIGTAIL COULD NOT BE CONFIRMED AND HENCE MAY HAVE BEEN CAUSED BY OTHER FACTORS. FOR EXAMPLE, THE LEAK MAY HAVE BEEN DUE TO A POOR CONNECTION ANYWHERE BETWEEN THE PIGTAIL AND THE PRESSURE TRANSDUCER (E.G. NUMEROUS STOPCOCKS AND NUMEROUS LUER FITTINGS) AND NOT A LEAKING PIGTAIL. NOTE THE UDI # IS (B)(4).

    Description of Event or Problem · 1

    FROM MEDWATCH REPORT (B)(4): THE BIGGER BETTER BLADDER IN THE ECMO CIRCUIT HAS AN AIR CHAMBER ON THE OUTSIDE FOR EQUILIBRATING THE PRESSURE DURING THE RUN THAT ENSURES APPROPRIATE NEGATIVE PRESSURE ON THE SYSTEM. DURING THE PREVIOUS NIGHT, SPECIALIST HAS TROUBLE MAINTAINING IN THE AIR CHAMBER TO THE RIGHT PRESSURE. THEY FOUND THE AIR CHAMBER PIGTAIL WAS LEAKING REQUIRING THE BLABBER TO BE CHANGED ON THE CIRCUIT. THE PATIENT WAS OFF BYPASS FOR 1:20 (ONE MINUTE 20 SECONDS) DURING THE CHANGE, BUT TOLERATED THE BRIEF TIME 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 BY BIOMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1154042 BIGGER BETTER BLADDER RESERVOIR, BLOOD, CARDIOPULMONARY BYPASS DTN CIRCULATORY TECHNOLOGY INC BBB38 5300-S19955 00851997007011

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR