BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINIMAX PLUS W/HARDSHELL

    MDR report key: 3940861 · Received July 17, 2014

    Report

    Report Number
    2184009-2014-00056
    Event Type
    Injury
    Date Received
    July 17, 2014
    Date of Event
    June 18, 2014
    Report Date
    June 18, 2014
    Manufacturer
    PERFUSION SYSTEMS
    Product Code
    DTZ
    PMA / PMN Number
    K933586
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    AT THE TIME OF THIS REPORT THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION. WITHOUT THE RETURN OF THE PRODUCT, NO DEFINITIVE CONCLUSION CAN BE MADE REGARDING THE CLINICAL OBSERVATION. SHOULD THE PRODUCT BE RETURNED, A FOLLOW-UP REPORT WILL BE SUBMITTED. PRODUCT RETURN HAS BEEN REQUESTED. (B)(4).

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION INDICATING THAT DURING THE CASE FOR SUPRAVALVULAR AORTIC STENOSIS AND PATENT FORAMEN OVALE, USING THIS MINIMAX OXYGENATOR, THERE WAS AN ISSUE WITH OXYGENATION. INITIALLY THE FRACTION OF INSPIRED OXYGEN (FIO2) WAS SET AT 70-85% AND THE PARTIAL PRESSURE OF OXYGEN(PO2) WAS 107MMHG. THE PHYSICIAN THEN SET FIO2 TO 80-85% AND PO2 WAS MORE THAN 200MMHG. FOLLOWING RE-WARMING (FIO2 AT 95%), POOR OXYGENATION WAS FOUND. FOLLOWING THE PROCEDURE, THE PATIENT WAS PLACED ON A BREATHING MACHINE. THE FIO2 OF BREATHING MACHINE WAS 80%, AND PO2 WAS 50%. THE PATIENT REMAINS IN THE CRITICAL CARE UNIT WITH WORSENING HYPOXEMIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    418144 MINIMAX PLUS W/HARDSHELL OXYGENATOR, CARDIOPULMONARY BYPASS DTZ PERFUSION SYSTEMS 3301 206994074

    Patients

    Seq Age Sex Outcome Treatment
    1 00005 YR Hospitalization| R