BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPIOX RX15 OXYGENATOR

    MDR report key: 4150995 · Received October 8, 2014

    Report

    Report Number
    9681834-2014-00255
    Event Type
    Injury
    Date Received
    October 8, 2014
    Date of Event
    September 3, 2014
    Report Date
    October 8, 2014
    Manufacturer
    TERUMO CORPORATION, ASHITAKA
    Product Code
    DTZ
    PMA / PMN Number
    K051997
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FOLLOW UP REPORT # 1 IS BEING SUBMITTED TO PROVIDE THE PATIENT STATUS AS WELL AS THE EVALUATION RESULTS OF THE RETURNED SAMPLE. VISUAL INSPECTION OF THE RETURN SAMPLE DID NOT FIND ANY ANOMALIES. THE SAMPLE WAS GAS TRANSFER TESTED BY CIRCULATING BOVINE BLOOD, MANUFACTURING PERFORMANCE MET SPECIFICATIONS. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED THAT THERE WERE NO PRODUCTION RELATED PROBLEMS FOR THIS LOT NUMBER. A REVIEW OF THE COMPLAINT FILES CONFIRMED THAT THIS LOT HAS NOT BEEN REPORTED PREVIOUSLY. THERE IS NO EVIDENCE THAT THIS EVENT WAS RELATED TO A DEVICE DEFECT OR MALFUNCTION. ALTHOUGH THE EXACT CAUSE CANNOT BE DETERMINED THE CAUSE OF THE COMPLAINT MAY BE RELATED TO THE STATE OF USE. IT IS LIKELY THAT V/Q WAS NOT 1 AND FIO2 WAS NOT 100% AT THE INITIATION OF THE CIRCULATION AND THE O2 VOLUME WAS NOT SUFFICIENT. THE DEVICE LABELING DOES ADDRESS THE POTENTIAL FOR SUCH AN OCCURRENCE IN THE INSTRUCTION FOR USE (IFU) WITH THE STATEMENT SUCH AS THE FOLLOWING: "START GAS SUPPLY WITH V/Q=1 AND FIO2=100%, THEN MAKE ADJUSTMENT BASED ON BLOOD GAS MEASUREMENTS." ALL AVAILABLE INFORMATION HAS BEEN PLACED ON FILE IN QUALITY ASSURANCE FOR APPROPRIATE TRACKING, TRENDING AND FOLLOW-UP.

    Additional Manufacturer Narrative · 1

    ALTHOUGH AN ESTIMATED VOLUME IS NOT AVAILABLE, THE REPORTED INFORMATION INDICATES THAT THE PEDIATRIC PATIENT EXPERIENCED BLOOD LOSS AS A RESULT OF THE OXYGENATOR CHANGE OUT. (B)(4). ALTHOUGH THERE WAS REPORTEDLY NO IMPACT TO THE PATIENT AND AN ESTIMATED VOLUME WAS NOT AVAILABLE, THE EVENT DESCRIPTION INDICATES THAT SOME BLOOD LOSS DID OCCUR DURING THE CHANGE OUT OF THE DEVICE. TERUMO HAS NOT YET RECEIVED THE ACTUAL DEVICE FOR EVALUATION; HOWEVER, A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE ACTUAL SAMPLE IS RECEIVED AND A FULL INVESTIGATION IS COMPLETE. AN EVALUATION OF THE SAME LOT RESERVE SAMPLE WAS CONDUCTED, AND THE VISUAL INSPECTION CONFIRMED THAT THERE WERE NO ANOMALIES. A REVIEW OF THE DEVICE HISTORY RECORD AND THE PRODUCT RELEASE DECISION CONTROL SHEET CONFIRMED THAT THERE WERE NO PRODUCTION RELATED PROBLEMS FOR THIS LOT NUMBER. A REVIEW OF THE COMPLAINT FILES CONFIRMED THAT THIS LOT HAS NOT BEEN PREVIOUSLY REPORTED. ALL AVAILABLE INFORMATION HAS BEEN PLACED ON FILE IN QUALITY MANAGEMENT FOR APPROPRIATE TRACKING, TRENDING AND FOLLOW UP. (B)(4).

    Description of Event or Problem · 1

    THIS REPORT IS BEING SUBMITTED AS FOLLOW-UP # 1 FOR MFR. REPORT # 9681834-2014-00255 TO PROVIDE THE PATIENT STATUS AS WELL AS THE EVALUATION RESULTS OF THE RETURNED SAMPLE. FOLLOW UP INFORMATION CONFIRMED THAT THE PATIENT LEFT THE CLINIC WITHOUT COMPLICATIONS ON (B)(6) 2014.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT DURING A CARDIOPULMONARY BYPASS (CPB) PROCEDURE, WHILE USING A CAPIOX RX15, THE PATIENT'S BLOOD TURNED DARK RED AFTER PERFUSION WAS STARTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE USER FACILITY: (1) WHEN PERFUSION WAS INITIALLY STARTED AND AFTER THE OXYGENATOR WAS ACTIVATED, THE PATIENT'S BLOOD WAS SCARLET RED; (2) APPROXIMATELY 1 - 1.5 MINUTES AFTER STARTING PERFUSION THE PATIENT'S BLOOD TURNED DARK RED; (3) THE MEDICAL STAFF MADE SEVERAL ATTEMPTS TO RESOLVE THE ISSUE BUT COULD NOT SO THE OXYGENATOR WAS CHANGED OUT; (3) SINCE THE CHANGE OUT OCCURRED APPROXIMATELY 3 MINUTES INTO THE PROCEDURE, IT WAS REPORTED THAT THERE WAS NO HARM TO THE PATIENT WHO LEFT THE CLINIC WITHOUT ANY COMPLICATIONS, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. HOWEVER, THE BLOOD LOSS DUE TO THE OXYGENATOR CHANGE OUT IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    633317 CAPIOX RX15 OXYGENATOR BLOOD GAS OXYGENATOR DTZ TERUMO CORPORATION, ASHITAKA NA 130327

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR Other