BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SECHRIST GAS BLENDER MODEL 3500CP-G

    MDR report key: 2645569 · Received June 29, 2012

    Report

    Report Number
    2020676-2012-00034
    Event Type
    Injury
    Date Received
    June 29, 2012
    Date of Event
    May 31, 2012
    Report Date
    June 29, 2012
    Manufacturer
    SECHRIST INDUSTRIES, INC.
    Product Code
    DTZ
    PMA / PMN Number
    K023745
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE RETURN REQUESTED TO EVALUATE AND DETERMINE ROOT CAUSE. WAITING FOR DEVICE RETURN. WILL PROVIDE FOLLOW-UP SUBMISSION ONCE DEVICE IS EVALUATED.

    Description of Event or Problem · 1

    A (B)(6) PT WAS RECEIVING AN AORTIC VALVE REPLACEMENT FOR THE DIAGNOSIS OF AORTIC INSUFFICIENCY. THE MIXER WAS BEING USED AS A COMPONENT OF A HEART/LUNG MACHINE. DURING THE SURGERY, THE DOCTOR NOTICED THE OXYGEN WAS LOW IN THE CIRCUIT WHICH SHOWED AS A DECREASED FIO2 READING FROM THE PT. THE DOCTOR DISCONNECTED AND RECONNECTED THE MIXER. ONCE THE OXYGEN TO THE CIRCUIT INCREASED, THE DOCTOR WORKED TO STOP THE BLEEDING OF THE PT AND THEN PROCEEDED TO COMPLETE THE SURGERY. THE PT IS RECOVERING AND IS IN GOOD CONDITION. THE MIXER WAS PERFORMANCE VERIFIED PRIOR TO THE SURGERY. AFTER THE SURGERY, THE DEVICE WAS TAKEN OUT OF SERVICE AND WAS EVALUATED BY A REPRESENTATIVE OF THE DISTRIBUTOR. EVALUATION FOUND THAT THE FLOW AND BALANCE OF THE MIXER WERE WITHIN NORMAL LIMITS. THERE WAS A NOISE COMING FROM THE BOTTOM OF THE DEVICE THAT SOUNDED LIKE A LEAK. THE WATERTRAP FILTER IS BROWN AND A COMPONENT OF THE FILTER IS BROKEN. A REQUEST FOR THE MAINTENANCE RECORDS OF THE DEVICE WAS REQUESTED BY THE DISTRIBUTOR. AT THAT TIME, HE WAS INFORMED THAT THE MIXER HAD NEVER RECEIVED MAINTENANCE. THE DEVICE IS 6 YEARS OLD. THE MANUFACTURER RECOMMENDS THAT THE INLET FILTER KIT BE REPLACED EVERY 6 MONTHS AND THE MIXER OVERHAULED EVERY 2 YEARS. REVIEW OF THE DOCUMENTATION SHOWING THE READINGS RECORDED DURING THE SURGERY REVEAL THAT THE SATURATION LEVEL VARIED BETWEEN 99-100%. AT 15 MINUTES INTO THE SURGERY, THE FIO2 WAS SET AT 70%. AFTER THAT, THE FIO2 WAS SENT TO 100%. THE PCO2 READINGS VARIED FROM 29-61.3.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SECHRIST GAS BLENDER MODEL 3500CP-G MIXER, GENERAL DTZ SECHRIST INDUSTRIES, INC. 3500CP-G

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Life Threatening| R