BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPIOX CUSTOM PACK

    MDR report key: 15637745 · Received October 20, 2022

    Report

    Report Number
    9681834-2022-00214
    Event Type
    Malfunction
    Date Received
    October 20, 2022
    Date of Event
    October 3, 2022
    Report Date
    October 20, 2022
    Manufacturer
    TERUMO CORPORATION, ASHITAKA
    Product Code
    DTZ
    PMA / PMN Number
    K071494
    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 - N/A AS THIS PRODUCT CODE IS NOT EXPORTED TO THE US MARKET. IMPLANTED DATE: DEVICE WAS NOT IMPLANTED. EXPLANTED DATE: DEVICE WAS NOT EXPLANTED. INITIAL REPORTER OCCUPATION - CLINICAL ENGINEER. PMA/510(K): K130520. THE ACTUAL SAMPLE WAS DISCARDED BY THE INVOLVED FACILITY; THEREFORE, THE DEVICE WAS NOT RETURNED TO ASHITAKA FACTORY FOR PRODUCT EVALUATION. REVIEW OF THE MANUFACTURING RECORD AND THE SHIPPING INSPECTION RECORD OF THE ACTUAL PRODUCT CONFIRMED THAT THERE WAS NOT ANY ANOMALY IN THEM. A SEARCH OF THE COMPLAINT FILE FOUND NO OTHER SIMILAR REPORT WITH THE INVOLVED PRODUCT CODE/LOT NUMBER COMBINATION. BASED ON THE INVESTIGATION RESULT, NO ANOMALY WAS FOUND IN THE MANUFACTURING RECORD. SINCE THE ACTUAL SAMPLE COULD NOT BE INVESTIGATED, THE CAUSE OF OCCURRENCE COULD NOT BE CLARIFIED. (B)(4).

    Description of Event or Problem · 0

    THAT USER FACILITY REPORTED THAT DURING EXTRACORPOREAL CIRCULATION OF THE CAPIOX CUSTOM PACK INVOLVED, THE TEMPERATURE WAS UNSTABLE, RISING AND FALLING BY APPROXIMATELY 5°C. IT WAS INFERRED THAT THERE WAS AN ISSUE WITH THE CABLE, AND THE PRODUCT WAS REPLACED WITH A NEW ONE; HOWEVER, THE ISSUE WAS NOT SOLVED. THE RECTAL TEMPERATURE WAS 36°C AT THE TIME OF WARMING; HOWEVER, THE BLOOD REMOVAL AND SENDING OF IT WAS ONLY APPROXIMATELY 34°C. THE RESULT WAS NOT RELIED UPON, AND THE PRODUCT WAS USED AS IS. THE EVENT OCCURRED INTRA-OPERATIVE. THERE WAS NO PATIENT INJURY/MEDICAL OR SURGICAL INTERVENTION REQUIRED. THE PROCEDURE OUTCOME WAS NOT REPORTED. THE FINAL PATIENT IMPACT WAS NOT HARMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2563031 CAPIOX CUSTOM PACK OXYGENATOR, CARDIOPULMONARY BYPASS DTZ TERUMO CORPORATION, ASHITAKA N/A 220120

    Patients

    Seq Age Sex Outcome Treatment
    1 Female