BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TYGON

    MDR report key: 742399 · Received June 26, 2006

    Report

    Report Number
    MW1039536
    Event Type
    Injury
    Date Received
    June 26, 2006
    Date of Event
    June 16, 2006
    Report Date
    June 26, 2006
    Manufacturer
    SAINT-GOBAIN PERFORMANCE PLASTICS
    Product Code
    DWE
    Adverse Event
    Yes
    Report Source
    Voluntary report

    Narratives

    Description of Event or Problem · 1

    TUBING THAT WAS THREADED AROUND THE ROLLER-HEAD OF AN EXTRACORPOREAL MEMBRANE OXYGENATION -ECMO- MACHINE CRACKED. THE TUBING WAS REMOVED FROM THE PUMP AND REPLACED WITH NEW TUBING. PT WAS REMOVED FROM ECMO SUPPORT DURING THIS REPAIR. PT REQUIRED ONE DOSE OF EPINEPHRINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TYGON TUBING DWE SAINT-GOBAIN PERFORMANCE PLASTICS S-65-HL *

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR Life Threatening| S