BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPIOX HOLLOW FIBER OXYGENATOR/ARTERIAL FILTER

    MDR report key: 11654664 · Received April 13, 2021

    Report

    Report Number
    9681834-2021-00057
    Event Type
    Injury
    Date Received
    April 13, 2021
    Date of Event
    March 26, 2021
    Report Date
    April 13, 2021
    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

    UDI - NOT REQUIRED FOR PRODUCT CODE. IMPLANTED DATE: DEVICE WAS NOT IMPLANTED. EXPLANTED DATE: DEVICE WAS NOT EXPLANTED. OCCUPATION- (B)(6). PMA/510(K)- K130280. THE ACTUAL SAMPLE WAS RECEIVED FOR EVALUATION. VISUAL INSPECTION REVEALED NO BREAKAGE IN THE VISIBLE RANGE. THE ACTUAL SAMPLE WAS RINSED, DRIED, AND BUILT INTO A CIRCUIT WITH TUBE. BOVINE BLOOD (HCT35% AND TEMP. 37°C) WAS CIRCULATED AT 1.5L/MIN IN THE CIRCUIT, WHILE THE PRESSURE DROP WAS DETERMINED. THE OBTAINED VALUES WERE CONFIRMED TO MEET THE FACTORY'S SPECIFICATIONS. NO BLOCKAGE WAS CONFIRMED. THE BLOOD THAT HAD REMAINED IN THE CIRCUIT WAS COLLECTED, FIXED WITH GLUTARALDEHYDE-CONTAINING PHYSIOLOGICAL SALINE SOLUTION, AND THEN DRIED FOR ELECTRON MICROSCOPIC INSPECTION. DEFORMED RED BLOOD CELLS (ECHINOCYTES) WERE OBSERVED. A REVIEW OF THE DEVICE HISTORY RECORD AND PRODUCT-RELEASE JUDGEMENT RECORD OF THE INVOLVED PRODUCT CODE/LOT# COMBINATION WAS CONDUCTED WITH NO FINDINGS. 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. BASED UPON THE DESCRIPTION OF THE EVENT THAT THE PRIMING WAS PERFORMED WHILE REMOVING WATER, AND ON THE INVESTIGATION RESULT THAT THE ECHINOCYTES WAS OBSERVED IN THE BLOOD COLLECTED FROM THE ACTUAL SAMPLE; IT IS LIKELY THAT THE BLOOD VISCOSITY INCREASED DUE TO INCREASING HCT, WHICH RESULTED IN THE OXYGENATOR PRESSURE RISE; THE BLOOD FLUIDITY DECREASED DUE TO RED BLOOD CELLS HAVING BEEN DEFORMED FOR SOME REASON, WHICH RESULTED IN THE OXYGENATOR PRESSURE RISE. HOWEVER, THE EXACT CAUSE OF THE REPORTED EVENT CANNOT BE DEFINITIVELY DETERMINED BASED ON THE AVAILABLE INFORMATION. TERUMO MEDICAL PRODUCTS (TMP) (IMPORTER) REGISTRATION NO. 2243441 IS SUBMITTING THIS REPORT ON BEHALF OF ASHITAKA FACTORY OF TERUMO CORPORATION (MANUFACTURER) REGISTRATION NO. (B)(4).

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT THE CAPIOX DEVICE WAS USED DURING THE PROCEDURE. PRIMING WAS PERFORMED WITH WATER FIRST, AND THEN BLOOD WAS ADDED WHILE WATER WAS REMOVED. THE OXYGENATOR PRESSURE INCREASED TO 300. THEY FELT ANOMALY AND RE-CONNECTED THE PRESSURE LINE TO MEASURE AGAIN, HOWEVER FOUND IT INCREASED AROUND 400. THE OXYGENATOR WAS EXCHANGED FOR A NEW ONE. CIRCUIT AND SHUNT SENSOR WERE CHANGED OUT ALSO. THE PROCEDURE OUTCOME WAS NOT REPORTED. THE PATIENT WAS NOT HARMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    551816 CAPIOX HOLLOW FIBER OXYGENATOR/ARTERIAL FILTER OXYGENATOR, CARDIOPULMONARY BYPASS DTZ TERUMO CORPORATION, ASHITAKA NA 201015

    Patients

    Seq Age Sex Outcome Treatment
    1 Other