BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPIOX FX OXYGENATOR

    MDR report key: 6311101 · Received February 8, 2017

    Report

    Report Number
    9681834-2017-00010
    Event Type
    Malfunction
    Date Received
    February 8, 2017
    Date of Event
    January 12, 2017
    Report Date
    February 8, 2017
    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 · 0

    D4: UDI FOR THIS PRODUCT CODE IS NOT REQUIRED TO BE REGISTERED WITH FDA. THE ACTUAL DEVICE WAS NOT RETURNED TO THE MANUFACTURING FACILITY. AN UNUSED SAMPLE FROM THE REPORTED PRODUCT CODE/LOT COMBINATION WAS RETURNED TO THE FACILITY FOR EVALUATION. VISUAL INSPECTION FOUND NO ANOMALIES. THE SAMPLE WAS TESTED FOR ITS GAS TRANSFER PERFORMANCE. NO ANOMALIES WERE REVEALED AND THE OBTAINED VALUES MET MANUFACTURING SPECIFICATIONS. A REVIEW OF THE DEVICE HISTORY RECORD AND THE PRODUCT RELEASE DECISION CONTROL SHEET OF THE INVOLVED PRODUCT/LOT # COMBINATION WAS CONDUCTED WITH NO RELEVANT FINDINGS. THE USER FACILITY REPORTED A SIMILAR EVENT FOR ANOTHER DEVICE WITH THE SAME PRODUCT/LOT NO. COMBINATION, SEE MDR 9681834-2017-00011FOR DETAILS. THERE IS NO EVIDENCE THAT THIS EVENT WAS RELATED TO A DEVICE DEFECT OR MALFUNCTION. THE SAMPLE WAS CONFIRMED TO BE NORMAL PRODUCT WITH ITS GAS TRANSFER PERFORMANCE MEETING SPECIFICATION. ALTHOUGH THE EXACT CAUSE OF THE REPORTED EVENT CANNOT BE DEFINITIVELY DETERMINED BASED ON THE AVAILABLE INFORMATION, THE FOLLOWING FACTORS CAN BE INFERRED: (1) HIGH HB PREVENTED PAO2 FROM RISING ADEQUATELY; AND (2) FIO2 LOWER THAN 100% AND INSUFFICIENT GAS FLOW RATE LED O2 SUPPLY VOLUME TO COME TO BE INSUFFICIENT. THE DEVICE LABELING DOES ADDRESS THE POTENTIAL FOR SUCH AN EVENT 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 ADJUSTMENTS BASED ON BLOOD GAS MEASUREMENTS." 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. ALL AVAILABLE INFORMATION HAS BEEN PLACED ON FILE IN QUALITY ASSURANCE FOR APPROPRIATE TRACKING, TRENDING AND FOLLOW-UP. H3 OTHER TEXT : ACTUAL DEVICE NOT RETURNED

    Description of Event or Problem · 0

    THE USER FACILITY REPORTED INSUFFICIENT GAS EXCHANGE IN THE CAPIOX DEVICE. FOLLOW UP COMMUNICATION WITH THE USER FACILITY CONFIRMED THE FOLLOWING INFORMATION: THE CUSTOMER USED A TUBING PACK CONTAINING THE ACTUAL FX15 SAMPLE; IT WAS REPORTED THAT CIRCULATION FOLLOWED NORMAL PROTOCOL BUT PO2 DID NOT INCREASED AS MUCH AS EXPECTED AND CO2 REMOVAL PERFORMANCE WAS POOR; THE CUSTOMER ADDRESSED THIS ISSUE BY CONTROLLING THE FLOW RATE AND DECREASING THE TEMPERATURE SLIGHTLY; THE PROCEDURE WAS COMPLETED SUCCESSFULLY; THE AMOUNT OF BLOOD LOSS IS UNKNOWN; AND THERE WAS NO HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    95473 CAPIOX FX OXYGENATOR OXYGENATOR, CARDIOPULMONARY BYPASS DTZ TERUMO CORPORATION, ASHITAKA NA 160906

    Patients

    Seq Age Sex Outcome Treatment
    1