BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPIOX CUSTOM PACK

    MDR report key: 17485284 · Received August 8, 2023

    Report

    Report Number
    9681834-2023-00155
    Event Type
    Malfunction
    Date Received
    August 8, 2023
    Date of Event
    July 13, 2023
    Report Date
    August 8, 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 CODE 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) - K071494, K130520. THE ACTUAL DEVICE HAS BEEN RETURNED FOR EVALUATION. VISUAL INSPECTION OF THE ACTUAL SAMPLE RESERVOIR WAS CONDUCTED UPON RECEIPT FOUND: (I) THAT THE FIBRINOUS BLOOD MENTIONED IN THE COMPLAINT DESCRIPTION COULD NOT BE CONFIRMED; (II) NO ANOMALY SUCH AS BREAKAGE WAS FOUND. THE ACTUAL SAMPLE WAS DISASSEMBLED, AND THE VENOUS FILTER AND THE DEFOAMER WERE SUBJECTED TO VISUAL INSPECTION FOUND: (I) THAT THE FORMATION OF BLOOD CLOT WAS OBSERVED ON THE VENOUS FILTER; (II) AND NO FORMATION OF BLOOD CLOT WAS FOUND IN THE DEFOAMER. THE CR FILTER AND THE DEFOAMER WERE SUBJECTED TO VISUAL INSPECTION FOUND: (I) THAT THE FORMATION OF A BLOOD CLOT WAS OBSERVED ON THE CR FILTER; (II) AND FORMATION OF BLOOD CLOT WAS OBSERVED ON THE INNER SURFACE OF DEFOAMER. THE VENOUS FILTER, CR FILTER, AND THE DEFOAMER, TO WHICH ADHESION OF BLOOD CLOTS WAS OBSERVED WERE SUBJECTED TO AN ELECTRON MICROSCOPIC INSPECTION. BLOOD CELL COMPONENTS SUCH AS RED BLOOD CELLS, DEFORMED RED BLOOD CELLS (ECHINOCYTES), AND PLATELETS WERE OBSERVED. VISUAL INSPECTION OF THE ACTUAL SAMPLE OXYGENATOR WAS CONDUCTED UPON RECEIPT FOUND NO ANOMALY SUCH AS BREAKAGE. THE ACTUAL SAMPLE WAS FILLED WITH A GLUTARALDEHYDE-CONTAINING SALINE SOLUTION, FIXED, AND DISASSEMBLED. VISUAL INSPECTION OF THE OXYGENATION MODULE FOUND NO ANOMALY IN THE CONDITION OF FIBER WINDING. THE HEAT EXCHANGER WAS REMOVED FROM THE OUTER CYLINDER AND SUBJECTED TO VISUAL AND MAGNIFYING INSPECTION FOUND: (I) FOUND NO FORMATION BLOOD CLOT WAS OBSERVED; (II) AND NO DEFORMATION OR OTHER ANOMALY THAT COULD LEAD TO AN OBSTRUCTION WAS FOUND IN THE HEAT EXCHANGER. REVIEW OF THE MANUFACTURING RECORD AND SHIPPING INSPECTION RECORD OF THE ACTUAL SAMPLE FOUND NO ANOMALY. A SEARCH OF THE PAST COMPLAINT FILE FOUND NO OTHER SIMILAR REPORT ON THE PRODUCT WITH THE INVOLVED PRODUCT CODE/LOT #. ACCORDING TO THE RESULTS OF THE INVESTIGATION, FORMATION OF BLOOD CLOT WAS FOUND ON THE VENOUS FILTER, THE CR FILTER, AND THE DEFOAMER; HOWEVER, THE FIBRINOUS BLOOD CLOT THAT WAS POINTED OUT IN THIS COMPLAINT COULD NOT BE IDENTIFIED, THE CAUSE OF OCCURRENCE IN THIS CASE COULD NOT BE CLARIFIED. 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. (B)(4) 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 THE FIBRINOUS BLOOD ADHERED TO THE RESERVOIR THAT WAS USED FOR HEPARIN-INDUCED THROMBOCYTOPENIA (HIT) PATIENT. THE OPERATION WAS FINISHED CONSERVATIVELY WITHOUT EXCHANGING THE CIRCUIT. THE EVENT OCCURRED INTRA-OPERATIVE. THE PATIENT WAS NOT INJURED DURING THE EVENT AND MEDICAL OR SURGICAL INTERVENTION WAS NOT REQUIRED. NO HEALTH DAMAGE TO THE PATIENT. THE PROCEDURE OUTCOME WAS COMPLETED SUCCESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1904991 CAPIOX CUSTOM PACK OXYGENATOR, CARDIOPULMONARY BYPASS DTZ TERUMO CORPORATION, ASHITAKA N/A 230426

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown