BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPIOX FX25 OXYGENATOR

    MDR report key: 14641907 · Received June 9, 2022

    Report

    Report Number
    9681834-2022-00106
    Event Type
    Malfunction
    Date Received
    June 9, 2022
    Date of Event
    May 11, 2022
    Report Date
    June 9, 2022
    Manufacturer
    TERUMO CORPORATION, ASHITAKA
    Product Code
    DTZ
    UDI-DI
    04987350701046
    PMA / PMN Number
    K071494
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PMA/510(K)- K130520. SINCE THE ACTUAL PRODUCT AND DETAILED INFORMATION WAS NOT AVAILABLE, IT WAS NOT POSSIBLE TO CLARIFY THE CAUSE OF OCCURRENCE. A REVIEW OF THE MANUFACTURING RECORD AND THE PRODUCT RELEASE DECISION CONTROL SHEET OF THE INVOLVED PRODUCT CODE/LOT NUMBER COMBINATION CONFIRMED THAT THERE WAS NOT ANY INDICATION OF ANOMALY IN THEM. A SEARCH OF THE COMPLAINT FILE FOUND NO OTHER SIMILAR REPORT WITH THE INVOLVED PRODUCT CODE/LOT NUMBER COMBINATION. RELEVANT IFU REFERENCE: "DO NOT REDUCE HEPARIN DURING CIRCULATION. OTHERWISE, BLOOD CLOTTING MIGHT OCCUR. (WARNINGS)" "ADEQUATE HEPARINIZATION OF THE BLOOD IS REQUIRED TO PREVENT IT FROM CLOTTING IN THE SYSTEM. (WARNINGS)" (B)(4).

    Description of Event or Problem · 0

    THE USER FACILITY REPORTED THAT THERE WAS A CLOT FORMED IN THE RESERVOIR ON THE OXYGENATOR DEVICE INVOLVED. THE LARGE CLOTS FORMED ON THE CARDIOTOMY SACK DURING BYPASS. THERE WAS A POTENTIAL RISK OF HARM DUE TO THE CLOT FORMATION IN THE RESERVOIR. THERE WAS NO MEDICAL OR SURGICAL INTERVENTION REQUIRED. THERE WAS NO HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2056862 CAPIOX FX25 OXYGENATOR OXYGENATOR, CARDIOPULMONARY BYPASS DTZ TERUMO CORPORATION, ASHITAKA NA 211119 04987350701046

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown