BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPIOX FX25 OXYGENATOR

    MDR report key: 15427502 · Received September 15, 2022

    Report

    Report Number
    9681834-2022-00185
    Event Type
    Malfunction
    Date Received
    September 15, 2022
    Date of Event
    August 23, 2022
    Report Date
    September 15, 2022
    Manufacturer
    TERUMO CORPORATION, ASHITAKA
    Product Code
    DTZ
    PMA / PMN Number
    K071494
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    UDI: N/A AS THIS PRODUCT IS A BULK UNIT. IMPLANTED DATE: DEVICE WAS NOT IMPLANTED. EXPLANTED DATE: DEVICE WAS NOT EXPLANTED. OCCUPATION - CHIEF PERFUSIONIST. PMA/510(K) - K130520 THE PROVIDED IMAGE SHOWED THAT RED FOAM WAS FLOWING OUT FROM THE GAS-OUT SIDE. REVIEW OF THE MANUFACTURING HISTORY RECORD AND THE SHIPPING INSPECTION RECORD OF THE ACTUAL SAMPLE CONFIRMED THAT THERE WAS NOT ANY ANOMALY IN THEM. A SEARCH OF THE COMPLAINT FILE FOUND NO OTHER SIMILAR REPORT FOR THE INVOLVED PRODUCT CODE/LOT NUMBER COMBINATION. BASED ON THE INVESTIGATION RESULTS, NO ANOMALIES WERE FOUND IN THE MANUFACTURING RELATED RECORDS. IN THIS CASE, SINCE THE ACTUAL SAMPLE WAS NOT RETURNED, ANALYSIS OF IT COULD NOT BE PERFORMED, THE CAUSE OF OCCURRENCE COULD NOT BE CLARIFIED. RELEVANT IFU REFERENCE: "DO NOT USE AN OXYGENATOR AND RESERVOIR THAT LEAKS. REPLACE IT WITH ANOTHER CAPIOX FX25 OXYGENATOR AND RESERVOIR. (B. PRIMING PROCEDURE WARNINGS)" (B)(4).

    Description of Event or Problem · 0

    THE USER FACILITY REPORTED THAT DURING THE CASE, A FIBER LEAKAGE HAD OCCURRED WITH THE CAPIOX FX25 DEVICE INVOLVED. THE CASE COULD BE COMPLETED WITHOUT EXCHANGE OF THE OXYGENATOR. THE PERFORMANCE WAS NOT AFFECTED. THERE WAS NO PATIENT INJURY/MEDICAL OR SURGICAL INTERVENTION REQUIRED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THE FINAL PATIENT IMPACT WAS NOT HARMED. THE EVENT OCCURRED INTRA-OPERATIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    269965 CAPIOX FX25 OXYGENATOR OXYGENATOR, CARDIOPULMONARY BYPASS DTZ TERUMO CORPORATION, ASHITAKA NA 210324

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown