BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPIOX®FX

    MDR report key: 20134960 · Received September 4, 2024

    Report

    Report Number
    9681834-2024-00150
    Event Type
    Malfunction
    Date Received
    September 4, 2024
    Date of Event
    August 6, 2024
    Report Date
    September 4, 2024
    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
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A1: PATIENT IDENTIFIER: REQUESTED, NOT PROVIDED. A2: DATE OF BIRTH: REQUESTED, NOT PROVIDED. A3A: SEX: REQUESTED, NOT PROVIDED. A3B: GENDER: N/A. A4: WEIGHT: REQUESTED, NOT PROVIDED. A5: ETHNICITY: REQUESTED, NOT PROVIDED. A6: RACE: REQUESTED, NOT PROVIDED. D4: UDI: N/A AS THIS PRODUCT CODE IS NOT EXPORTED TO THE US MARKET. D6A: IMPLANTED DATE: DEVICE WAS NOT IMPLANTED. D6B: EXPLANTED DATE: DEVICE WAS NOT EXPLANTED. E3: OCCUPATION: CLINICAL ENGINEER. G4: PMA/510(K): K130280. VISUAL INSPECTION OF THE ACTUAL SAMPLE UPON RECEIPT FOUND NO BREAKAGE OR SIMILAR ANOMALY IN THE APPEARANCE. THE ACTUAL SAMPLE IN THE CONDITION AS RECEIVED WAS INSTALLED INTO A CIRCUIT CONSISTING OF TUBES, AND SALINE SOLUTION WAS CIRCULATED TO MEASURE THE PRESSURE DROP. IT WAS FOUND THAT THE PRESSURE DROP WAS HIGH COMPARED TO THAT OF A CURRENT PRODUCT. THE ACTUAL SAMPLE WAS FILLED WITH GLUTARALDEHYDE-CONTAINING SALINE SOLUTION AND FIXED, THEN THE HOUSING AND THE FILTER WERE REMOVED FOR THE VISUAL INSPECTION OF THE GAS TRANSFER PART. NO ANOMALY WAS FOUND IN THE CONDITION OF FIBER WINDING. THE GAS TRANSFER PART WAS INSPECTED VISUALLY WHILE THE FIBER LAYER WAS REMOVED GRADUALLY. NO ANOMALY WAS FOUND IN THE CONDITION OF FIBER WINDING. IT WAS FOUND THAT WHITE CLOTS HAD BEEN FORMED. THE HEAT EXCHANGER WAS REMOVED FROM THE OUTER CYLINDER AND SUBJECTED TO VISUAL AND MAGNIFYING INSPECTIONS. IT WAS CONFIRMED THAT WHITE CLOTS HAD BEEN FORMED. NO DEFORMATION OF THE CHANNEL THAT COULD LEAD TO A CLOGGING WAS OBSERVED. THE FIBER WAS INSPECTED WITH AN ELECTRON MICROSCOPE. AGGREGATION OF PLATELETS WAS CONFIRMED. THE MANUFACTURING RECORD AND THE SHIPPING INSPECTION RECORD OF THE ACTUAL SAMPLE, NO ANOMALY WAS FOUND. NO OTHER SIMILAR REPORT WAS FOUND. BASED ON THE INVESTIGATION OF THE ACTUAL SAMPLE, IT CAN BE INFERRED THAT A CLOGGING OCCURRED DUE THE PLATELET AGGREGATION, LEADING TO THE REPORTED INCREASE IN PRE-OXYGENATOR PRESSURE. HOWEVER, THE SPECIFIC FACTOR THAT CAUSED THE PLATELET AGGREGATION COULD NOT BE DETERMINED FROM THE INVESTIGATION OF THE SAMPLE. RELEVANT INSTRUCTIONS FOR USE (IFU) REFERENCE: "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." TERUMO MEDICAL PRODUCTS (TMP) (IMPORTER) REGISTRATION NO. 2243441 IS SUBMITTING THIS REPORT ON BEHALF OF ASHITAKA FACTORY OF TERUMO CORPORATION (MANUFACTURER) REGISTRATION NO. 9681834.

    Description of Event or Problem · 0

    THE USER FACILITY REPORTED THAT CIRCULATION STARTED WITH THE INVOLVED PRECONNECTED CIRCUIT. POST-OXYGENATOR PRESSURE WAS 100MMHG WHILE THE PRE-OXYGENATOR PRESSURE BECAME 500MMHG. ACT JUST AFTER THE PUMP STARTED WAS 480. FLOW RATE WAS DECREASED TO REGULATE THE PRE-OXY PRESSURE TO 450MMHG, AND THE CIRCULATION CONTINUED. THERE WAS NO PATIENT INJURY/MEDICAL OR SURGICAL INTERVENTION REQUIRED. THE PROCEDURE OUTCOME WAS NOT REPORTED. THE PATIENT WAS NOT HARMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    967145 CAPIOX®FX OXYGENATOR, CARDIOPULMONARY BYPASS DTZ TERUMO CORPORATION, ASHITAKA CX-XRZ12611 231207

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown HLM