BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPIOX FX OXYGENATOR

    MDR report key: 13861000 · Received March 23, 2022

    Report

    Report Number
    9681834-2022-00039
    Event Type
    Malfunction
    Date Received
    March 23, 2022
    Date of Event
    February 22, 2022
    Report Date
    March 22, 2022
    Manufacturer
    TERUMO CORPORATION, ASHITAKA
    Product Code
    DTZ
    PMA / PMN Number
    K071494
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    UDI - N/A, AS THIS PRODUCT CODE IS BULK ITEM. IMPLANTED DATE: DEVICE WAS NOT IMPLANTED. EXPLANTED DATE: DEVICE WAS NOT EXPLANTED. PHONE NUMBER: UNKNOWN. HEALTH PROFESSIONAL: UNKNOWN. OCCUPATION-UNKNOWN. PMA/510(K)- K071494, K130520. THE ACTUAL DEVICE WAS NOT RETURNED FOR EVALUATION. THE PHOTO RECEIVED FROM WHEN THE EVENT WAS DISCOVERED WAS CONFIRMED. IT WAS FOUND THAT THE TUBE WAS DAMAGED AT THE ROOT OF SAMPLING LINE CONNECTED TO THE RESERVOIR VENOUS BLOOD INLET PORT. REVIEW OF THE MANUFACTURING HISTORY RECORD AND THE PRODUCT RELEASE DECISION CONTROL SHEET OF THE ACTUAL PRODUCT CONFIRMED THAT THERE WERE NOT ANY INDICATIONS OF ANOMALY IN THEM. A SEARCH OF THE COMPLAINT FILE FOUND NO OTHER SIMILAR REPORT WITH THE INVOLVED PRODUCT CODE/LOT# COMBINATION. BEFORE SHIPPING THIS PRODUCT, 100% VISUAL INSPECTION IS PERFORMED. SINCE THIS CASE WAS DISCOVERED BY THE USER, IT WAS INFERRED THAT THIS CASE WAS CAUSED BY SOME SHOCK FORCE APPLIED BETWEEN THE TIME THE PRODUCT WAS INSTALLED IN THE CIRCUIT AND THE TIME IT WAS PRIMED. ESPECIALLY WHEN TRANSPORTED THIS PRODUCT AT LOW TEMPERATURES, VINYL CHLORIDE, WHICH IS THE MATERIAL OF THE TUBE, HARDENS AND MAY BE EASILY DAMAGED. IFU STATES: IF THE PRODUCT IS DROPPED DURING SET-UP, DO NOT USE IT. REPLACE WITH ANOTHER DEVICE. (A. SET-UP, CAUTION). (B)(4).

    Description of Event or Problem · 0

    THE USER FACILITY REPORTED THE CAPIOX DEVICE INVOLVED HAD A BREAK IN THE SAMPLE LINE (CONNECTED TO RESERVOIR) WHICH MADE IT IMPOSSIBLE TO USE ON THE PATIENT. THERE WAS NO PATIENT DAMAGE, BECAUSE THE PERFUSIONIST NOTICED THE PROBLEM DURING THE PRIMMING AND CHANGED THE PACK FOR A NEW ONE. THERE WAS NO DELAY ON THE SURGERY. THERE WAS NO BLOOD LOSS. THE EVENT OCCURRED PRE-TREATMENT. THERE WAS NO MEDICAL OR SURGICAL INTERVENTION REQUIRED. THE PATIENT WAS NOT HARMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    924851 CAPIOX FX OXYGENATOR OXYGENATOR, CARDIOPULMONARY BYPASS DTZ TERUMO CORPORATION, ASHITAKA NA 210222

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown