BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPIOX HOLLOW FIBER OXYGENATOR/ARTERIAL FILTER

    MDR report key: 12015238 · Received June 17, 2021

    Report

    Report Number
    9681834-2021-00104
    Event Type
    Malfunction
    Date Received
    June 17, 2021
    Date of Event
    June 1, 2021
    Report Date
    June 17, 2021
    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

    Narratives

    Additional Manufacturer Narrative · 1

    UDI: NOT REQUIRED FOR PRODUCT CODE. IMPLANTED DATE: DEVICE WAS NOT IMPLANTED. EXPLANTED DATE: DEVICE WAS NOT EXPLANTED. OCCUPATION- CLINICAL ENGINEER. PMA/510(K)- K130280. THE ACTUAL SAMPLE WAS RECEIVED FOR EVALUATION. VISUAL INSPECTION REVEALED NO ANOMALY INCLUDING A BREAKAGE IN THE APPEARANCE. THE ACTUAL SAMPLE WAS FIXED BY BEING FILLED WITH GLUTARALDEHYDE-CONTAINING NORMAL SALINE, AND THEN THE HOUSING AND THE FILTER WERE REMOVED. VISUAL INSPECTION OF THE OXYGENATION MODULE FOUND NO FORMATION OF BLOOD CLOTS THAT COULD LEAD TO THE INCREASING PRESSURE. THE OXYGENATION MODULE WAS VISUALLY INSPECTED WHILE THE FIBER LAYER WAS REMOVED GRADUALLY. FORMATION OF BLOOD CLOTS THAT COULD LEAD TO THE INCREASING PRESSURE WAS NOT CONFIRMED. NO ANOMALY WAS NOTED IN THE STATE OF FIBER WINDING. THE HEAT EXCHANGER WAS REMOVED FROM THE OUTER CYLINDER AND SUBJECTED TO VISUAL AND MAGNIFYING INSPECTIONS. FORMATION OF WHITE CLOT WAS OBSERVED. ANY DEFORMITY THAT COULD CAUSE ANY OBSTRUCTION WAS NOT OBSERVED. REVIEW OF PUMP RECORD REVEALED THE PRESSURE DROP OF OXYGENATOR STARTED TO BE IN AN INCREASING TREND AROUND 13:00, BEFORE THE BLOOD FLOW RATE WAS RAISED AT 13:06. IT WAS SHOWN THAT SODIUM BICARBONATE WAS ADMINISTERED AT 13:01, WHEN THE PRESSURE DROP INCREASED OBVIOUSLY, HOWEVER, THE CAUSAL RELATION BETWEEN THE INCREASING PRESSURE DROP AND THE ADMINISTRATION OF THE DRUG WAS NOT CLARIFIED. EVEN AFTER THE BLOOD FLOW RATE WAS MADE DECREASED AT 13:18, THE PRESSURE DROP DID NOT DECREASE AND WAS STILL IN THE INCREASING TREND. AS THE PRESSURE DROP DID NOT CHANGE IN PROPORTION TO THE BLOOD FLOW RATE, IT WAS THOUGHT THAT THE OXYGENATOR STARTED TO CLOG AT AROUND 13:00. WHEN THE ARTERIAL BLOOD TEMPERATURE WAS LOWERED AT 13:01, THE PRESSURE DROP WAS FOUND TO INCREASE. A GRADUAL DECREASE IN PRESSURE DROP WAS OBSERVED AFTER THE ARTERIAL BLOOD TEMPERATURE WAS RAISED AT 14:02. THEREFORE, SINCE THERE WAS A RELATIONSHIP BETWEEN THE PRESSURE DROP AND THE TEMPERATURE OF ARTERIAL BLOOD, IT WAS THOUGHT THAT COLD AGGLUTINATION MAY HAVE BEEN A FACTOR OF CLOGGING. 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. IT IS LIKELY THAT THE CAUSE OF THIS INCIDENT WAS A CHANGE IN BLOOD PROPERTIES THAT CAUSED BLOOD-DERIVED CLOGGING AND INCREASED PRESSURE. HOWEVER, IT WAS NOT POSSIBLE TO CLARIFY THE CAUSE OF THE BLOOD-DERIVED CLOGGING FROM THE INVESTIGATION RESULTS OF THE ACTUAL SAMPLE. 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 DURING THE PROCEDURE, THE CAPIOX DEVICE WAS USED. PRESSURE BEFORE THE OXYGENATOR INCREASED JUST AFTER PUMP WAS ON. THEY WERE CONCERNED ABOUT IT, HOWEVER, SINCE THE PLANNED PUMPING TIME WAS SHORT, THEY CONTINUED USING THE PRODUCT IN QUESTION AS IT WAS UNTIL THE PUMP WAS OFF. THE PATIENT WAS NOT HARMED. THE PROCEDURE OUTCOME WAS NOT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    912841 CAPIOX HOLLOW FIBER OXYGENATOR/ARTERIAL FILTER OXYGENATOR, CARDIOPULMONARY BYPASS DTZ TERUMO CORPORATION, ASHITAKA NA 201210

    Patients

    Seq Age Sex Outcome Treatment
    1