BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPIOX FX OXYGENATOR

    MDR report key: 19741730 · Received July 15, 2024

    Report

    Report Number
    9681834-2024-00119
    Event Type
    Malfunction
    Date Received
    July 15, 2024
    Date of Event
    June 16, 2024
    Report Date
    July 15, 2024
    Manufacturer
    TERUMO CORPORATION, ASHITAKA
    Product Code
    DTZ
    UDI-DI
    04987350739087
    PMA / PMN Number
    K071572
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED AS FOLLOW UP NO. 2 TO PROVIDE THE COMPLETED INVESTIGATION RESULTS. NO ACTUAL SAMPLE WAS RETURNED. BASED ON THE INVESTIGATION RESULT, NO ANOMALY WAS FOUND IN THE MANUFACTURING RECORD AND THE SHIPPING INSPECTION RECORD. SINCE IT WAS NOT POSSIBLE TO CONFIRM THE ACTUAL SAMPLE IN THIS CASE, IT WAS NOT POSSIBLE TO CLARIFY THE CAUSE. PLEASE NOTE THAT THE INSTRUCTIONS FOR USE (IFU) OF CAPIOX FX05 INDICATES THE FOLLOWING FOR YOUR REFERENCE: "BAND ALL CONNECTIONS IN THE CIRCUIT." "ENSURE THAT ALL CONNECTED PARTS INCLUDING THE LUER CAPS, THE LOCK ADAPTERS AND THE PORT CAPS ARE SECURELY AFFIXED. LOOSE CONNECTIONS MAY CAUSE CONTAMINATION OR A BLOOD LEAK."

    Additional Manufacturer Narrative · 0

    D6A: IMPLANTED DATE: DEVICE WAS NOT IMPLANTED. D6B: EXPLANTED DATE: DEVICE WAS NOT EXPLANTED. E2: HEALTH PROFESSIONAL: UNKNOWN. E3: OCCUPATION: DIRECTOR OF CARDIOVASCULAR PERFUSION. 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. IT WAS INITIALLY REPORTED THAT THE INVOLVED PRODUCT CODE WAS CX*FX05RW AND THE LOT NUMBER WAS 230529. HOWEVER, UPON INVESTIGATION, IT WAS DETERMINED THAT NO PRODUCT WITH THIS SPECIFIC COMBINATION EXISTS. THEREFORE, THE INVESTIGATION WAS CONDUCTED WITH AN UNKNOWN LOT NUMBER AT THIS STAGE. SINCE THE INVOLVED LOT NUMBER WAS UNKNOWN, IT COULD NOT BE CONFIRMED. THERE HAVE BEEN NO REPORTS OF TUBING DISCONNECTION RELATED TO THE INVOLVED PRODUCT CODE IN THE PAST TWO YEARS. TERUMO MEDICAL PRODUCTS (TMP) (IMPORTER) REGISTRATION NO. 2243441 IS SUBMITTING THIS REPORT ON BEHALF OF ASHITAKA FACTORY OF TERUMO CORPORATION (MANUFACTURER) REGISTRATION NO. 9681834.

    Additional Manufacturer Narrative · 0

    MANUFACTURING RECORD AND THE SHIPPING INSPECTION RECORD OF THE ACTUAL SAMPLE FOUND NO ANOMALY. NO COMPLAINTS WERE RECEIVED REGARDING "SUCKER PRIME TUBING DISCONNECTED" IN THE PAST.

    Description of Event or Problem · 0

    THE USER FACILITY REPORTED THAT THE SUCKER PRIME TUBING WAS DISCONNECTED. THE EVENT OCCURRED DURING PRE-CARDIOPULMONARY BYPASS. THE EVENT DID NOT RESULT IN A DELAY IN THE BEGINNING OR CONTINUING THE SURGICAL PROCEDURE. THE EXACT TUBING WAS LIVANOVA. THE PRODUCT WAS NOT CHANGED OUT AND THE SURGERY WAS COMPLETED SUCCESSFULLY. THE PRODUCT MALFUNCTION DID NOT CAUSE OR CONTRIBUTE TO AN INJURY. NO BLOOD LOSS WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    285048 CAPIOX FX OXYGENATOR OXYGENATOR, CARDIOPULMONARY BYPASS DTZ TERUMO CORPORATION, ASHITAKA CX*FX05RWA 230529 04987350739087

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown