BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPIOX FX05

    MDR report key: 10458639 · Received August 27, 2020

    Report

    Report Number
    9681834-2020-00162
    Event Type
    Injury
    Date Received
    August 27, 2020
    Date of Event
    July 30, 2020
    Report Date
    August 27, 2020
    Manufacturer
    TERUMO CORPORATION, ASHITAKA
    Product Code
    DTZ
    PMA / PMN Number
    K071572
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    IMPLANTED DATE: DEVICE WAS NOT IMPLANTED. EXPLANTED DATE: DEVICE WAS NOT EXPLANTED. PMA/510K: 510(K) - K130280. THE ACTUAL SAMPLE WAS RECEIVED FOR EVALUATION. VISUAL INSPECTION REVEALED NO OBVIOUS ANOMALIES, SUCH AS A BREAK, IN THE APPEARANCE. THE ACTUAL SAMPLE AFTER RINSED AND DRIED WAS BUILT INTO A CIRCUIT WITH TUBE, AND THEN BOVINE BLOOD (HCT35% AND TEMP. 37°) WAS CIRCULATED IN THE CIRCUIT AT 1.5L/MIN, WHILE THE PRESSURE DROP WAS DETERMINED. THE OBTAINED VALUES WERE CONFIRMED TO MEET THE MANUFACTURER SPECIFICATIONS. NO OBSTRUCTION WAS CONFIRMED. A REVIEW OF THE DEVICE HISTORY RECORD AND THE PRODUCT-RELEASE JUDGEMENT RECORD OF THE INVOLVED PRODUCT CODE/LOT# COMBINATION WAS CONDUCTED WITH NO FINDINGS. THE PUMP RECORD WAS REVIEWED, HOWEVER, NO FACTORS THAT COULD LED TO THE PRESSURE RISE COULD BE READ FROM THE DATA. IFU STATES: DO NOT REDUCE HEPARIN DURING CIRCULATION. OTHERWISE, BLOOD CLOTTING MIGHT OCCUR. ADEQUATE HEPARINIZATION OF THE BLOOD IS REQUIRED TO PREVENT IT FROM CLOTTING IN THE SYSTEM. BASED ON THE PROVIDED INFORMATION AND INVESTIGATION RESULTS, THERE IS NO DEFINITIVE EVIDENCE THAT THIS EVENT WAS RELATED TO A DEVICE DEFECT OR MALFUNCTION. THE INVESTIGATION RESULTS VERIFIED THE RETURNED SAMPLE WAS OF NORMAL PRODUCT. IT IS LIKELY THAT CLOGGING CAUSED BY BLOOD OCCURRED DUE TO SOME FACTORS, RESULTING IN THE PRESSURE RISE. HOWEVER, THE EXACT CAUSE OF THE REPORTED EVENT CANNOT BE DEFINITIVELY DETERMINED BASED ON THE AVAILABLE INFORMATION. (B)(4).

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT THE INVOLVED CAPIOX DEVICE WAS USED DURING THE PROCEDURE, A REGULAR VSD PATCH CLOSURE CASE. AFTER ECC WAS STARTED, PRESSURE AT THE OXYGENATOR OUTLET BEGUN TO RISE. IN 40 MINUTES, THE PUMP WAS STOPPED, AND THE OXYGENATOR WAS CHANGED OUT. AFTER THE CIRCULATION WAS STOPPED FOR 12 MINUTES, ECC WAS RESTARTED TO COMPLETE THE OPERATION. THEY EXCHANGED WITH ANOTHER BRAND'S OXYGENATOR. THE PATIENT WAS NOT HARMED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    923186 CAPIOX FX05 OXYGENATOR, CARDIOPULMONARY BYPASS DTZ TERUMO CORPORATION, ASHITAKA NA 200210

    Patients

    Seq Age Sex Outcome Treatment
    1 Other