BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPIOX CUSTOM PACK

    MDR report key: 17465651 · Received August 4, 2023

    Report

    Report Number
    9681834-2023-00156
    Event Type
    Malfunction
    Date Received
    August 4, 2023
    Date of Event
    July 6, 2023
    Report Date
    August 4, 2023
    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

    A1: PATIENT IDENTIFIER: REQUESTED, NOT PROVIDED. A2: AGE & DATE OF BIRTH: REQUESTED, NOT PROVIDED. A3: PATIENT SEX: REQUESTED, NOT PROVIDED. A4: WEIGHT: REQUESTED, NOT PROVIDED. A5: ETHNICITY: REQUESTED, NOT PROVIDED. A6: RACE: REQUESTED, NOT PROVIDED. D4: UDI: N/A AS THIS PRODUCT IS NOT EXPORTED TO THE US MARKET. D6A: IMPLANTED DATE: REQUESTED, NOT PROVIDED. D6B: EXPLANTED DATE: REQUESTED, NOT PROVIDED. E3: OCCUPATION: CLINICAL ENGINEER. G4: PMA/510(K) - K130520. 1.INSPECTION OF THE ACTUAL SAMPLE: 1.1. VISUAL INSPECTION OF THE ACTUAL SAMPLE UPON RECEIPT FOUND NO ANOMALY SUCH AS A BREAKAGE. 1.2. THE ACTUAL SAMPLE WAS FILLED WITH GLUTARALDEHYDE-CONTAINING SALINE SOLUTION AND FIXED, THE HOUSING AND FILTER WERE REMOVED, AND VISUAL INSPECTION OF THE GAS TRANSFER PART WAS PERFORMED. NO ANOMALY WAS FOUND IN THE CONDITION OF FIBER WINDING. WHITE ADHERENTS WERE FOUND ON THE REMOVED FILTER. 1.3. THE FIBER LAYER WAS REMOVED GRADUALLY, AND VISUAL INSPECTION OF THE GAS TRANSFER PART WAS PERFORMED. NO ANOMALY WAS FOUND IN THE CONDITION OF FIBER WINDING. 1.4. THE HEAT EXCHANGER WAS REMOVED FROM THE OUTER CYLINDER AND SUBJECTED TO VISUAL AND MAGNIFYING INSPECTION. WHITE ADHERENTS WERE FOUND. NO DEFORMATION OR OTHER ANOMALY THAT COULD LEAD TO AN OBSTRUCTION WAS FOUND IN THE HEAT EXCHANGER. 2. REVIEW OF PUMP RECORD: IT WAS CONFIRMED THAT EXTRACORPOREAL CIRCULATION STARTED AT 23:44. AN ARROW WAS WRITTEN IN THE PUMP RECORD JUST AFTER 4:14, IN ADDITION, FROM THE INFORMATION THAT THE MERA OXYGENATOR WAS EXCHANGED WITH FX15 AT 4:15, IT WAS THOUGHT THAT THE EXCHANGE OF OXYGENATOR WAS DONE AT THIS TIME. PO2 RECORDED AT AROUND 4:34, AFTER EXCHANGING MERA WITH FX15, WAS 261MMHG. THE CIRCULATION CONDITIONS AT THIS TIME COULD NOT BE READ FROM THE PUMP RECORD. A SECOND ARROW WAS WRITTEN AROUND 5:09, AND PCPS WAS ALSO WRITTEN BELOW IT, SO IT WAS THOUGHT THAT PCPS WAS INTRODUCED AT THIS TIME. 3. HISTORY INVESTIGATION: 3.1. REVIEW OF THE MANUFACTURING RECORD AND THE SHIPPING INSPECTION RECORD OF THE ACTUAL SAMPLE FOUND NO ANOMALY. 3.2. REVIEW OF THE PAST COMPLAINT FILE FOUND NO OTHER SIMILAR REPORT ON THE INVOLVED PRODUCT CODE/LOT NUMBER. 3.3. MANUFACTURING DATE: NOVEMBER 29, 2022. 4. CAUSE OF OCCURRENCE/CONCLUSION: DURING THE INVESTIGATION, WHITE ADHERENTS WERE FOUND INSIDE THE ACTUAL SAMPLE. THOUGH THE WHITE ADHERENTS WERE FOUND, AS FOR THE CAUSE OF OCCURRENCE, THE CAUSAL RELATION BETWEEN THE WHITE ADHERENTS AND THE POOR GAS TRANSFER PERFORMANCE WAS NOT CLARIFIED. IN ADDITION, IT WAS NOT POSSIBLE TO CLARIFY ITS PROPERTIES FROM THE RESULTS OF THE INVESTIGATION. RELEVANT IFU REFERENCE: "MEASURE BLOOD GASES AND MAKE NECESSARY ADJUSTMENTS AS FOLLOWS. A. CONTROL PAO2 BY CHANGING CONCENTRATION OF OXYGEN IN VENTILATING GAS USING GAS BLENDER. TO DECREASE PAO2, DECREASE FIO2. TO INCREASE PAO2, INCREASE FIO2. B. CONTROL PACO2 BY CHANGING THE TOTAL GAS FLOW. TO DECREASE PACO2, INCREASE TOTAL GAS FLOW. TO INCREASE PACO2, DECREASE TOTAL GAS FLOW." 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 · 0

    THE USER FACILITY REPORTED THAT IT WAS AN EMERGENCY CASE, MERA OXYGENATOR OF MERA L-CIRCUIT WAS USED INITIALLY. AS THE OXYGENATION PERFORMANCE DECREASED, AROUND 4:15, FX15 ONLY FROM XRY39001 CIRCUIT WAS USED TO PERFORM ECC. AFTERWARD, THE PERFORMANCE OF FX15 DECREASED ALSO. AFTER PUMPING, THEY PROCEEDED TO PCPS, HOWEVER, THOUGH THE PERFORMANCE WAS IMPROVED SOMEWHAT WHEN THE PATIENT WAS COOLED, OVERALL GAS EXCHANGE PERFORMANCE WAS POOR FOR BOTH MERA AND FX15. IT WAS AN EMERGENCY CASE, THE PATIENT'S TG WAS ABOUT 3700, AND THE BLOOD INSIDE THE CIRCUIT SEEMED WHITE POSSIBLY DUE TO FAT. THE PROCEDURE OUTCOME WAS NOT REPORTED. THE PATIENT WAS NOT HARMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1812169 CAPIOX CUSTOM PACK OXYGENATOR, CARDIOPULMONARY BYPASS DTZ TERUMO CORPORATION, ASHITAKA N/A 221129

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown CDI| S5