BEUDAMED
    FDA Adverse Event Death Summary report: N

    INTELLIPACK

    MDR report key: 2303567 · Received October 18, 2011

    Report

    Report Number
    2303567
    Event Type
    Death
    Date Received
    October 18, 2011
    Date of Event
    October 10, 2011
    Report Date
    October 18, 2011
    Manufacturer
    MAQUET
    Product Code
    DWF
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NC, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE TUBING INSIDE THE RACEWAY RUPTURED, CAUSING THE PUMP TO STOP. THE PT WAS PLACED ON EMERGENCY VENTILATOR SETTINGS WHILE THE RACEWAY WAS REPLACED. THE PT ARRESTED AND CPR WAS STARTED. THE PT'S CARDIAC FUNCTION DID NOT RETURN, AND THE TEAM STOPPED CPR. THE PATIENT EXPIRED. THIS WAS THE SECOND RUPTURE WITHIN A MONTH. THE MATTER WAS INVESTIGATED AND REVEALED THAT THE TUBING IN THE RACEWAY WAS MADE WITH POLYMERIZED VINYL CHLORIDE (PVC) RATHER THAN TYGON S95. PVC CANNOT WITHSTAND THE ROLLER PRESSURE THAT CIRCULATES THE BLOOD, WHICH IS WHY IT RUPTURED. MAQUET PROVIDED US WITH REPLACEMENT RACEWAYS MADE FROM THE CORRECT TUBING -TYGON S95. THEY WERE OVERNIGHTED TO US TO REPLACE THE RACEWAY IN THE CIRCUITS THAT WERE ON THE SHELF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTELLIPACK ECMO PUMP RACEWAY CIRCUIT DWF MAQUET * 13067

    Patients

    Seq Age Sex Outcome Treatment
    1 3 DA Death