BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOLLOW FIBER OXYGENATOR

    MDR report key: 4325722 · Received December 12, 2014

    Report

    Report Number
    9681834-2014-00310
    Event Type
    Malfunction
    Date Received
    December 12, 2014
    Date of Event
    September 30, 2014
    Report Date
    December 12, 2014
    Manufacturer
    TERUMO CORPORATION, ASHITAKA
    Product Code
    DTZ
    PMA / PMN Number
    K071494
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE ACTUAL DEVICE WAS NOT RETURNED TO THE MANUFACTURING FACILITY FOR EVALUATION AND THE LOT NUMBER IS UNKNOWN. THEREFORE, THE INVESTIGATION WAS BASED UPON EVALUATION OF USER FACILITY INFORMATION AND PERFUSION RECORDS PROVIDED BY THE INVOLVED HOSPITAL. (B)(4)PERFUSION RECORDS FOR THE TIME PERIOD OF JULY, 2014 TO OCTOBER, 2014 WERE PROVIDED FROM THE INVOLVED HOSPITAL FOR OUR REVIEW. THE FOLLOWING INFORMATION WAS EVALUATED FROM THE PERFUSION RECORDS: (1) AO2 HAD FALLEN DOWN AFTER AO DE-CLAMPING; (2) RE-WARMING WAS INITIATED AROUND (BEFORE/AFTER) AO DE-CLAMPING; (3) THE TIMING OF WEANING FROM THE BYPASS WAS WHEN THE BLOOD TEMPERATURE REACHED 36 DEGREES-C BY RE-WARMING; AND (4) ALL 15 PROCEDURES WERE COMPLETED SUCCESSFULLY. THERE WAS NO ANOMALY IN THE GAS TRANSFER PERFORMANCE AT THE INITIATION OF THE CIRCULATION IN THE 15 PROCEDURES CONDUCTED WITHIN THE SPECIFIED TIME MENTIONED ABOVE. THE TUBING PACK LOT #S OF THIS PRODUCT CODE PRESUMABLE TO HAVE BEEN USED FOR THE TIME PERIOD OF JULY, 2014 TO OCTOBER, 2014 ARE 140409, 140613 AND 140717. REVIEW OF THE DEVICE HISTORY RECORD OF THE OXYGENATOR MODULE USED FOR THESE TUBING PACK LOT #S CONFIRMED THAT THERE WAS NO INDICATION OF PRODUCTION-RELATED PROBLEM. THERE IS NO EVIDENCE THAT THIS EVENT WAS RELATED TO A DEVICE DEFECT OR MALFUNCTION. ALTHOUGH THE EXACT CAUSE CANNOT BE DETERMINED BASED ON THE AVAILABLE INFORMATION, IT IS LIKELY THAT BLOOD DETERIORATED IN SVO2 AS A RESULT OF THE PATIENT'S METABOLISM ACTIVATED BY RE-WARMING FLOWED INTO THE OXYGENATOR MODULE AND PO2 FALL DOWN TEMPORARILY. DEVICE LABELING DOES ADDRESS THE POTENTIAL FOR SUCH AN EVENT IN THE INSTRUCTIONS-FOR-USE BY STATEMENTS SUCH AS: "DURING PERFUSION, PRIOR TO RESUMING BYPASS, SET FIO2 AT 100% TO ENSURE ADEQUATE OXYGENATION. INCREASED PCO2 AND DECREASED PO2 IN THE PATIENT'S BLOOD AT THE BEGINNING OF RECIRCULATION MAY NOT BE ABLE TO BE RECOVERED WITHOUT APPRECIATE GAS SUPPLY." ALL AVAILABLE INFORMATION HAS BEEN PLACED ON FILE IN QUALITY ASSURANCE FOR APPROPRIATE TRACKING, TRENDING AND FOLLOW-UP. (B)(4): DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED INSUFFICIENT GAS TRANSFER ON THE OXYGENATOR DEVICE. FOLLOW UP COMMUNICATION WITH THE USER FACILITY REPORTED THE FOLLOWING INFORMATION: (1) AFTER AO DECLAMPING, AT THE WEANING STAGE, IT WAS NOTICED THAT THE GAS TRANSFER WAS INSUFFICIENT; (2) WITHOUT INCREASING FIO2 UP TO 100%, PO2 FELL BELOW 250MMHG; (3) THE OPERATION WAS CONTINUED AND COMPLETED SUCCESSFULLY; AND (4) THERE WAS NO HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    808962 HOLLOW FIBER OXYGENATOR OXYGENATOR DTZ TERUMO CORPORATION, ASHITAKA NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR