BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPIOX FX25 OXYGENATOR

    MDR report key: 15137146 · Received August 1, 2022

    Report

    Report Number
    9681834-2022-00146
    Event Type
    Malfunction
    Date Received
    August 1, 2022
    Date of Event
    June 28, 2022
    Report Date
    August 1, 2022
    Manufacturer
    TERUMO CORPORATION, ASHITAKA
    Product Code
    DTZ
    PMA / PMN Number
    K071572
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    IMPLANTED DATE: DEVICE WAS NOT IMPLANTED, EXPLANTED DATE: DEVICE WAS NOT EXPLANTED, REPORTER OCCUPATION- CLINICAL ENGINEER, PMA/510(K)- K130280. THE ACTUAL SAMPLE WAS DISCARDED BY THE USER FACILITY, THEREFORE AN EVALUATION OF THE ACTUAL SAMPLE COULD NOT BE CONDUCTED. REVIEW OF THE MANUFACTURING RECORD AND THE PRODUCT-RELEASE JUDGMENT RECORD OF THE INVOLVED PRODUCT/LOT# COMBINATION CONFIRMED THAT THERE WERE NOT ANY ANOMALIES IN THEM. A SEARCH OF THE COMPLAINT FILE FOUND NO OTHER SIMILAR REPORTS WITH THE INVOLVED PRODUCT CODE/LOT# COMBINATION FROM OTHER FACILITIES. NO ANOMALY WAS CONFIRMED IN THE MANUFACTURING RELATED RECORDS. SINCE THE ACTUAL SAMPLE WAS NOT RETURNED FOR THE INVESTIGATION, THE CAUSE OF OCCURRENCE COULD NOT BE CLARIFIED. IFU STATES: "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.(CAUTION)" TERUMO MEDICAL PRODUCTS (TMP) (IMPORTER) REGISTRATION NO. (B)(4) IS SUBMITTING THIS REPORT ON BEHALF OF ASHITAKA FACTORY OF TERUMO CORPORATION (MANUFACTURER) REGISTRATION NO. (B)(4).

    Description of Event or Problem · 0

    THE USER FACILITY REPORTED LEAKAGE OF PRIMING SOLUTION AT THE CONNECTION OF THE SAMPLING LINE AND THE OUTLET PORT OF THE OXYGENATOR. IT WAS FOUND DURING PRIMING. NORMALLY, ALL CONNECTIONS ARE RE-TIGHTENED, BUT NOT THAT PART. (THEY WERE NOT AWARE OF THE SAID CONNECTION.) THEY SOLVED THE ISSUE BY DISCONNECTING THE LOCKING PART ONCE AND THEN RECONNECTING IT. THE PROCEDURE OUTCOME WAS NOT REPORTED. THE PATIENT WAS NOT HARMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2924826 CAPIOX FX25 OXYGENATOR OXYGENATOR, CARDIOPULMONARY BYPASS DTZ TERUMO CORPORATION, ASHITAKA NA 220218

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown