BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO

    MDR report key: 1982228 · Received February 3, 2011

    Report

    Report Number
    MW5019305
    Event Type
    Malfunction
    Date Received
    February 3, 2011
    Date of Event
    February 3, 2011
    Report Date
    February 3, 2011
    Manufacturer
    TERUMO
    Product Code
    DTZ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    OPEN HEART CASE UNDERWAY, PT VENTILATED AND O2 SAT AT 100%, PT PLACED ON BYPASS, IMMEDIATELY NOTICED BLOOD TO BE BRIGHT PINK. PUMP CHECKED BY PERFUSIONIST, O2 SUPPLY CHANGED, NO CHANGE IN COLOR. PT IMMEDIATELY TAKEN OFF BYPASS AND VENTILATED AGAIN BY ANESTHESIA, O2 SAT REMAINED AT 100%. OXYGENATOR CHANGED OUT BY PERFUSION. PT PLACED BACK ON BYPASS, BLOOD BRIGHT RED WITH SURGERY CONTINUING. TOTAL TIME 4 MIN. NO ADVERSE OUTCOME TO PT. FAULTY OXYGENATOR FROM MANUFACTURER. THIS IS A ITEM THAT CANNOT BE CHECKED UNTIL THE PT GOES ON BYPASS AND YOU SEE THAT OXYGENATION IS NOT OCCURRING. IMMEDIATE AND APPROPRIATE ACTION TAKEN BY PERFUSION, ANESTHESIA AND SURGEONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TERUMO RX25 OXYGENATOR DTZ TERUMO RX25 OXYGENATOR MF10

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR