BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3500CP-G - MIXER, GENERAL, ENGLISH

    MDR report key: 2492802 · Received January 10, 2012

    Report

    Report Number
    2020676-2012-00001
    Event Type
    Malfunction
    Date Received
    January 10, 2012
    Date of Event
    November 28, 2011
    Report Date
    January 10, 2012
    Manufacturer
    SECHRIST INDUSTRIES, INC.
    Product Code
    BZR
    PMA / PMN Number
    K992503
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE RETURN REQUESTED. FULL FUNCTION EVALUATION SHALL BE CONDUCTED ONCE DEVICE IS RECEIVED. UPDATE ON PERFORMANCE RESULTS WILL BE PROVIDED IN FOLLOW-UP WHEN AVAILABLE. REPORTEDLY OCCURRED DURING CARDIOPULMONARY BYPASS. APPROXIMATELY 3 TO 4 MINUTES INTO USE, CUSTOMER REPORTED DEVICE COULD NOT SUPPLY SUITABLE MIXING GAS FOR FIO2 TARGETED TO PATIENT. DEVICE MALFUNCTIONED WITH ALARM. CUSTOMER DESCRIBED RETURN OF BLOOD AT INITIATION OF ECMO WAS DARK COLOR. CUSTOMER CHANGED TO OXYGEN SUPPLY DIRECTLY FROM WALL. NO INJURIES AND NO DEATH TO PATIENT REPORTED. THE FOLLOWING ARE CONTACT COMMENTS IN REGARD TO INCIDENT. HOSPITAL DOES NOT HAVE EXPERIENCE WITH ECMO. THE USERS DID NOT THINK ALARM WAS REAL ALARM. BLENDER HAS NORMAL OPERATING RANGE OF INLET SUPPLY GAS PRESSURE 30-70 PSI. DEVICE WAS NOT USED WITHIN OPERATING RANGE. OPERATED OVER 75 PSI. DEVICE OPERATED WITH REGULATOR BUT MADE ALARM NOISE. DEVICE HAS NEVER BEEN OVERHAULED OR SERVICE AS REPORTED.

    Description of Event or Problem · 1

    CUSTOMER DESCRIBED RETURN OF BLOOD AT INITIATION OF ECMO WAS DARK COLOR. CUSTOMER CHANGED TO OXYGEN SUPPLY DIRECTLY FROM WALL. NO INJURIES AND NO DEATH TO PATIENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 3500CP-G - MIXER, GENERAL, ENGLISH AIR/OXYGEN MIXER BZR SECHRIST INDUSTRIES, INC. 3500CP-G

    Patients

    Seq Age Sex Outcome Treatment
    1 Other