BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPIOX FX OXYGENATOR

    MDR report key: 8654138 · Received May 30, 2019

    Report

    Report Number
    9681834-2019-00093
    Event Type
    Injury
    Date Received
    May 30, 2019
    Date of Event
    May 2, 2019
    Report Date
    May 30, 2019
    Manufacturer
    TERUMO CORPORATION, ASHITAKA
    Product Code
    DTZ
    UDI-DI
    04987350701046
    PMA / PMN Number
    K071572
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED AS FOLLOW UP NO. 1 TO PROVIDE CORRECTIONS TO SECTIONS D4 AND G5; TO UPDATE SECTION D10, H3, AND TO PROVIDE THE COMPLETED INVESTIGATION. UPON RECEIPT OF THE ACTUAL SAMPLE, IT WAS FOUND TO BE A CX*FX05RW, NOT THE INITIALLY REPORTED CX*FX25RW. THE INVOLVED DEVICE WAS CONFIRMED TO BE CX*FX05RW, THEREFORE, HAS BEEN CORRECTED. G5. PMA/510(K): K130280. THE ACTUAL SAMPLE WAS RECEIVED FOR EVALUATION. VISUAL INSPECTION REVEALED A CRACK ON THE BLOOD OUTLET PORT AND A SCRATCH ON THE BLOOD INLET PORT ON THE OXYGENATOR MODULE. THERE WAS NOT ANY OTHER ANOMALY, SUCH AS A BREAK, IN THE APPEARANCE ON THE REMAINDERS OF THE DEVICE. THE ACTUAL SAMPLE, AFTER HAVING BEEN RINSED AND DRIED, WAS BUILT INTO A CIRCUIT WITH TUBES AND TESTED FOR ITS GAS TRANSFER PERFORMANCE IN ACCORDANCE WITH THE FACTORY'S SHIPPING INSPECTION PROTOCOL. BOVINE BLOOD ARRANGED TO (HB12.0 G/DL, TEMP.37OC., PH:7.4, SVO2:65% AND PVCO2:45MMHG) WAS CIRCULATED IN THE OXYGENATOR MODULE UNDER THE FOLLOWING CONDITIONS: @ V/Q=1, FIO2=100% AND THE FLOW RATE OF 2L/MIN. AND 1/MIN. RESULT: O2 TRANSFER VOLUME: @2L/MIN.= 121ML/MIN. @1L/MIN.= 69ML/MIN. CO2 REMOVAL VOLUME: @2L/MIN.= 104ML/MIN. @1L/MIN.= 56ML/MIN. NO ANOMALIES WERE REVEALED IN THE GAS TRANSFER PERFORMANCE OF THE ACTUAL SAMPLE, WITH THE OBTAINED VALUES MEETING MANUFACTURER SPECIFICATIONS. BASED ON THE PROVIDED INFORMATION AND INVESTIGATION RESULTS, THERE IS NO DEFINITIVE EVIDENCE THAT THIS EVENT WAS RELATED TO A DEVICE DEFECT OR MALFUNCTION. THE INVESTIGATION RESULTS VERIFIED THE RETURNED SAMPLE WAS OF THE NORMAL PRODUCT WITH NO ISSUE IN THE GAS TRANSFER PERFORMANCE. HOWEVER, THE EXACT CAUSE OF THE REPORTED EVENT CANNOT BE DEFINITIVELY DETERMINED BASED ON THE AVAILABLE INFORMATION.

    Additional Manufacturer Narrative · 0

    IMPLANTED DATE: DEVICE WAS NOT IMPLANTED. EXPLANTED DATE: DEVICE WAS NOT EXPLANTED. HEALTH PROFESSIONAL: UNKNOWN. INITIAL REPORTER OCCUPATION: UNKNOWN. THE 510(K): K130520. THE ACTUAL DEVICE HAS NOT BEEN RETURNED FOR EVALUATION. THE INVESTIGATION IS CURRENTLY ONGOING. A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE. A REVIEW OF THE DEVICE HISTORY RECORD AND PRODUCT RELEASE DECISION CONTROL SHEET OF THE PRODUCT CODE/LOT# COMBINATION WAS CONDUCTED WITH NO FINDINGS. TERUMO MEDICAL PRODUCTS (TMP) (IMPORTER) REGISTRATION NO. 2243441 IS SUBMITTING THIS REPORT ON BEHALF OF ASHITAKA FACTORY OF TERUMO CORPORATION (MANUFACTURER) REGISTRATION NO. 9681834. EXEMPTION NUMBER E2015022.

    Description of Event or Problem · 0

    THE USER FACILITY REPORTED THAT STOCK FROM (B)(6); THE CAPIOX FAILED WITHIN 3 MIN OF BYPASS STARTING. DEVICE WAS NOT OXYGENATING; DID MANUAL BLOOD GAS AS CONFIRMATION. THEY STOPPED THE BYPASS, AND THE OXYGENATOR WAS CHANGED OUT, AND WAS WORKED FINE. THERE WAS NO HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    448090 CAPIOX FX OXYGENATOR OXYGENATOR, CARDIOPULMONARY BYPASS DTZ TERUMO CORPORATION, ASHITAKA NA 180413 04987350701046

    Patients

    Seq Age Sex Outcome Treatment
    1 Other