BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUADROX ID PEDIATRIC

    MDR report key: 4212933 · Received October 24, 2014

    Report

    Report Number
    2248146-2014-00442
    Event Type
    Injury
    Date Received
    October 24, 2014
    Date of Event
    July 23, 2014
    Report Date
    September 26, 2014
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DTZ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RETURNED TO THE FACTORY AND IS BEING EVALUATED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE EVAL IS COMPLETED. UF REPORT #: (B)(4) WAS RECEIVED FROM THE FDA ON 09/30/2014. THIS EVENT WAS PREVIOUSLY REPORTED MFR REPORT #: 8010762-2014-00753/IMPORTER REPORT #: (B)(4). EVAL OF THE RETURNED DEVICE DETERMINED THIS IS DATASCOPE PRODUCT AND NOT MAQUET CARDIOPULMONARY AG. COMPLAINT #: (B)(4).

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED TO THE FDA ON (B)(6) 2014 THAT A PT WAS PLACED ON SUPPORT USING THE QUADROX ID PEDIATRIC OXYGENATOR. AFTER 13 HOURS ON SUPPORT THE OXYGENATOR CLOTTED DAN REQUIRED A CHANGE OTU. THE ECMO COORDINATOR INFORMED ME THAT THE PT WAS NOT ON HEPARIN AT THE TIME TH E CLOTTING OCCURRED. SHE SAVED THE OXYGENATOR FOR INSPECTION BY MAQUET. THE MFR REPORTED THAT 12 HOURS INTO IT'S RUN, AN OXYGENATOR SHOWED SIGNS OF OBSTRUCTION WITH INCREASED TRANSMEMBRANE PRESSURES AND INCREASED RPM REQUIREMENTS. THE OXYGENATOR WAS THEN CHANGED OUT AND FLOW WAS MAINTAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    678887 QUADROX ID PEDIATRIC CARDIOPULMONARY DTZ DATASCOPE CORP.

    Patients

    Seq Age Sex Outcome Treatment
    1 7 MO Required Intervention