BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPIOX FX OXYGENATOR

    MDR report key: 13635790 · Received March 1, 2022

    Report

    Report Number
    9681834-2022-00019
    Event Type
    Malfunction
    Date Received
    March 1, 2022
    Date of Event
    February 1, 2022
    Report Date
    March 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

    UDI - NOT REQUIRED FOR PRODUCT CODE. IMPLANTED DATE: DEVICE WAS NOT IMPLANTED. EXPLANTED DATE: DEVICE WAS NOT EXPLANTED. OCCUPATION- CLINICAL ENGINEER. PMA/510K # - K130280. THE ACTUAL SAMPLE WAS NOT AVAILABLE FOR INVESTIGATION. SINCE THE ACTUAL SAMPLE WAS NOT RETURNED TO ASHITAKA FACTORY, THE INVESTIGATION OF IT WAS UNABLE TO BE PERFORMED. HOWEVER, THE IMAGE OF THE ACTUAL SAMPLE SHOWED THAT THE SAMPLING SYSTEM HAD BEEN DETACHED FROM THE MOUNT. 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 REPORT WITH THE INVOLVED PRODUCT CODE/LOT# COMBINATION. IFU STATES: "DO NOT USE IF THE PACKAGE OR DEVICE IS DAMAGED (E.G. CRACKED) OR ANY OF THE PORT CAPS ARE OFF." BASED ON THE INVESTIGATION AND OUR EXPERIENCE, AS A POSSIBLE CAUSE OF OCCURRENCE, IT WAS INFERRED THAT THEY ATTEMPTED TO DETACH THE MOUNT FROM THE RESERVOIR IN A WAY GRABBING THE SAMPLING SYSTEM ONLY. SINCE THE ACTUAL SAMPLE WAS NOT RETURNED FOR ANALYSIS, THE CAUSE OF OCCURRENCE COULD NOT BE CLARIFIED. 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 THAT DURING PRIMING OF THE CAPIOX DEVICE THEY FOUND THAT THE SAMPLING SYSTEM DISLODGED, SO THEY STOPPED USING IT AND REPLACED IT WITH A NEW ONE IMMEDIATELY. THE PROCEDURE OUTCOME WAS NOT REPORTED. THERE WAS NO HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2283301 CAPIOX FX OXYGENATOR OXYGENATOR, CARDIOPULMONARY BYPASS DTZ TERUMO CORPORATION, ASHITAKA NA 210729

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown