BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPIOX CUSTOM PACK

    MDR report key: 11601461 · Received April 1, 2021

    Report

    Report Number
    9681834-2021-00033
    Event Type
    Injury
    Date Received
    April 1, 2021
    Date of Event
    March 5, 2021
    Report Date
    April 1, 2021
    Manufacturer
    TERUMO CORPORATION, ASHITAKA
    Product Code
    DTZ
    PMA / PMN Number
    K071494
    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-CLINICAL ENGINEER. PMA/510(K)- K130520. THE ACTUAL SAMPLE WAS RECEIVED FOR EVALUATION. VISUAL INSPECTION REVEALED NO BREAKAGE IN THE VISIBLE RANGE. THE ACTUAL SAMPLE WAS BUILT INTO A CIRCUIT WITH TUBING, AND THEN PHYSIOLOGICAL SALINE SOLUTION WAS CIRCULATED IN THE BLOOD CHANNEL AT EACH FLOW RATE WHILE THE PRESSURE DROP WAS MEASURED. COMPARED TO A CURRENT PRODUCT, NO MARKED DIFFERENCE WAS OBSERVED IN THE OBTAINED VALUES. THE ACTUAL SAMPLE WAS FILLED WITH GLUTARALDEHYDE-CONTAINING PHYSIOLOGICAL SALINE SOLUTION AND FIXED, AND THEN THE HOUSING AND THE FILTER WERE REMOVED. VISUAL INSPECTION OF THE FILTER DID NOT FIND ANY FORMATION OF BLOOD CLOTS, WHICH COULD CAUSE PRESSURE RISE, ON NEITHER SIDE OF THE FILTER. SUBSEQUENTLY, VISUAL INSPECTION OF THE OXYGENATION MODULE DID NOT FIND ANY FORMATION OF BLOOD CLOTS, WHICH COULD CAUSE PRESSURE RISE. NO ANOMALY WAS OBSERVED IN THE WINDING STATE OF FIBER. THE HEAT EXCHANGER WAS REMOVED FROM THE OUTER CYLINDER AND INSPECTED WITH NAKED EYE AND MAGNIFIER. NO OCCLUSION OR NO OTHER ANOMALY WAS OBSERVED IN THE FLOW PATH. A REVIEW OF THE DEVICE HISTORY RECORD AND PRODUCT-RELEASE JUDGEMENT RECORD OF THE INVOLVED PRODUCT CODE/LOT# COMBINATION WAS CONDUCTED WITH NO FINDINGS. REVIEW OF THE PUMP RECORD REVEALED THAT THE ECC STARTED AT 18:43 AND ENDED AT 18:48. IT WAS CONCEIVABLE THAT THE PRESSURE DROP INCREASED DURING THIS PERIOD. 60ML OF 7% SODIUM BICARBONATE WAS ADMINISTERED BETWEEN 18:43 AND 18:48. BLOOD GAS AT 18:48 INDICATED PH: 7.660, PCO2: 20.8MMHG, BE: 7.1MMOL/L. BLOOD GAS AT 18:39 (PRE-ECC) INDICATED PH: 7.416, PCO2: 31 MMHG, BE: -4.2MMOL/L. FROM THIS, IT WAS FOUND THAT PH AND BE INCREASED AND PCO2 DECREASED DURING THE ECC. IFU STATES: STOP THE GAS FLOW WHEN CIRCULATION IS SUSPENDED. DURING RECIRCULATION, CHECK BLOOD GAS PRESSURE. EXCESSIVE GAS FLOW MAY CAUSE LOW PACO2, ALKALOSIS, OR BLOOD DAMAGE. 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 WAS LIKELY THAT THE ADMINISTRATION OF SODIUM BICARBONATE OVERLAPPED THE DECREASE IN PCO2, PH MAY HAVE INCREASED. RBC DEFORMED DUE TO THE EFFECT OF INCREASED PCO2, COMPROMISING BLOOD FLUIDITY, WHICH RESULTED IN THE INCREASING PRESSURE DROP. 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 THAT THE CAPIOX CUSTOM PACK WAS USED DURING THE PROCEDURE. PRESSURE RISE OCCURRED SOON AFTER THE PUMP STARTED. ONLY 2L/MIN COULD BE OBTAINED. PRESSURE ROSE UP TO 400MMHG BEFORE THE OXYGENATOR AND UP TO 150 MMHG AFTER THE OXYGENATOR. THE OXYGENATOR WAS CHANGED OUT, AND THE PROCEDURE WAS COMPLETED WITH NO FURTHER PROBLEM. THEY CONSIDER ALKALOSIS AS A CAUSE OF THE PRESSURE RISE. THE FIRST BLOOD GAS INDICATED BE GREATER THAN 7. AS THE PRESSURE RISE OCCURRED JUST AFTER THE PUMP STARTED, THE PATIENT WAS ONCE WEANED, AND THE OXYGENATOR WAS EXCHANGED. THE PROCEDURE WAS FINISHED SUCCESSFULLY WITH A SUBSTITUTION. THE PATIENT WAS NOT HARMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    497938 CAPIOX CUSTOM PACK OXYGENATOR, CARDIOPULMONARY BYPASS DTZ TERUMO CORPORATION, ASHITAKA NA 201028

    Patients

    Seq Age Sex Outcome Treatment
    1 Other