BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THE BETTER BLADDER

    MDR report key: 1712403 · Received May 19, 2010

    Report

    Report Number
    1712403
    Event Type
    Injury
    Date Received
    May 19, 2010
    Date of Event
    April 4, 2010
    Report Date
    May 10, 2010
    Manufacturer
    CIRCULATORY TECHNOLOGY INC
    Product Code
    DWE
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    UT, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    THE PT WAS SOMEWHAT HYPOVOLEMIC BASED ON THE ASSESSMENT OF THE SURGEON. THE PT WAS PLACED ON THE ECMO PUMP. THE BLADDER ON THE ECMO CIRCUIT SUDDENLY COLLAPSED. THE ECMO FLOW SIGNIFICANTLY DECREASED AND VOLUME WAS PUSHED INTO THE BLADDER WITH NO RESOLUTION OF THE BLADDER COLLAPSING. THE ECMO PUMP WAS STOPPED AND THE PRACTITIONER WAS STILL UNABLE TO FULLY EXPAND THE BLADDER WITH VOLUME. AIR WAS NOTED IN THE VENOUS CANNULA, BUT NOT IN THE RA VENT OR ARTERIAL CANNULA. CPR WAS INITIATED WHILE THE ECMO CIRCUIT AND PUMP WERE CHECKED FOR RESOLUTION. THE DOCTOR WAS AT THE BEDSIDE TO CONFIRM THE CANNULAS' PLACEMENT: IVC CANNULA, LA VENT AND AORTIC CANNULA. THE PRACTITIONER WAS STILL UNABLE TO RESUME FLOW DUE TO THE COLLAPSED BLADDER. THE ECMO CIRCUIT WAS CHANGED AND THE PT WAS PLACED BACK ON THE ECMO PUMP. A LOT OF VOLUME WAS REQUIRED IN ORDER TO PREVENT BLADDER COLLAPSE. THE PT WAS TAKEN TO SURGERY TO EXPLORE THE CHEST AND TO CONFIRM THE CANNULAS' PLACEMENT. BASED ON THE INFORMATION PROVIDED BY THE DOCTOR, IT APPEARS THAT THE LIKELIHOOD OF THIS EVENT RESULTED FROM A COMBINATION OF FACTORS THAT ARE BOTH MECHANICAL AND PHYSIOLOGIC. IT WAS NOT POSSIBLE TO COMPLETELY ASSESS THE PUMP ISSUES BECAUSE THE CIRCUIT WAS DISPOSED OF BEFORE IT COULD BE TESTED FOR ANY PRODUCT DEFECTS OR FAILURES. HOWEVER, WE WERE ABLE TO REPEAT THE BLADDER COLLAPSE AND CIRCUIT ISSUES IN THE WET LAB BY ALLOWING AIR TO ENTER THE CONNECTIONS AND STOPCOCK'S ON THE CIRCUIT. IF THE CONNECTIONS ARE NOT TIGHTENED, OR IF THEY ARE CRACKED, AND THE TRANSDUCERS ARE CRACKED, AIR IS PERMITTED INTO THE SYSTEM. THIS CAN CAUSE A COLLAPSE OF THE BLADDER. BIOMEDICAL ENGINEERING EVALUATED THE ECMO PUMP ITSELF AND FOUND IT TO BE WORKING AS PER THE MANUFACTURER'S STANDARDS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 THE BETTER BLADDER ECMO, CIRCUIT, BLADDER DWE CIRCULATORY TECHNOLOGY INC * *

    Patients

    Seq Age Sex Outcome Treatment
    1 6 YR Required Intervention