BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPIOX FX25

    MDR report key: 17343163 · Received July 18, 2023

    Report

    Report Number
    9681834-2023-00141
    Event Type
    Malfunction
    Date Received
    July 18, 2023
    Date of Event
    June 20, 2023
    Report Date
    July 18, 2023
    Manufacturer
    TERUMO MEDICAL CORPORATION
    Product Code
    DTZ
    PMA / PMN Number
    K071494
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    A1: PATIENT IDENTIFIER: REQUESTED, NOT PROVIDED. A2: DATE OF BIRTH: REQUESTED, NOT PROVIDED. A5: ETHNICITY: REQUESTED, NOT PROVIDED. A6: RACE: REQUESTED, NOT PROVIDED. D4: CATALOG NUMBER: UNKNOWN. D4: LOT NUMBER: UNKNOWN. D4: EXPIRATION DATE: UNKNOWN DUE TO UNKNOWN CATALOG NUMBER AND UNKNOWN LOT NUMBER. D4: UDI NO: DI NUMBER CANNOT BE CONFIRMED SINCE THE INVOLVED PRODUCT CODE AND LOT# ARE UNKNOWN. D6A: IMPLANTED DATE: DEVICE WAS NOT IMPLANTED. D6B: EXPLANTED DATE: DEVICE WAS NOT EXPLANTED. E2: HEALTH PROFESSIONAL: UNKNOWN. E3: OCCUPATION: OTHERS. G4: 510(K) NO: K071494, K130520. H4: DEVICE MANUFACTURE DATE: UNKNOWN DUE TO UNKNOWN CATALOG NUMBER AND UNKNOWN LOT NUMBER. THE ACTUAL SAMPLE WAS DISCARDED BY THE INVOLVED FACILITY. RECORD REVIEW: THE MANUFACTURING RECORD AND THE SHIPPING INSPECTION RECORD OF THE ACTUAL PRODUCT: AS THE PRODUCT CODE AND LOT# WERE UNKNOWN, IT WAS NOT POSSIBLE TO INVESTIGATE. PAST COMPLAINT FILE: AS THE PRODUCT CODE AND LOT# WERE UNKNOWN, IT WAS NOT POSSIBLE TO INVESTIGATE. MANUFACTURING DATE: UNKNOWN. CAUSE OF OCCURRENCE/CONCLUSION: BASED ON OUR EXPERIENCE, THE FOLLOWING FACTORS COULD HAVE COMBINED TO CAUSE THE REPORTED ISSUE; HOWEVER, THE ACTUAL PRODUCT COULD NOT BE CONFIRMED, AND THE CAUSE OF OCCURRENCE COULD NOT BE CLARIFIED. OUR RESERVOIR IS DESIGNED TO STRUCTURALLY STABILIZE THE LIQUID SURFACE OF BLOOD STORED IN THE RESERVOIR IN ORDER TO MAKE IT EASIER TO MANAGE THE LIQUID LEVEL. ON THE OTHER HAND, THE RESERVOIR HAS A CHARACTERISTIC THAT MAKES IT DIFFICULT TO AGITATE THE BLOOD INSIDE THE RESERVOIR. BLOOD WITH ACTIVATED BLOOD-CLOTTING FACTOR FLOWED INTO THE RESERVOIR AND ACCUMULATED AT THE LIQUID LEVEL, RESULTING IN THE FORMATION OF BLOOD CLOTS. RELEVANT INSTRUCTIONS FOR USE (IFU) REFERENCE: "DO NOT REDUCE HEPARIN DURING CIRCULATION. OTHERWISE, BLOOD CLOTTING MIGHT OCCUR. (WARNINGS). ADEQUATE HEPARINIZATION OF THE BLOOD IS REQUIRED CONSIDERING PATIENT CONDITION AND PERFUSION TECHNIQUE TO PREVENT IT FROM CLOTTING IN THE SYSTEM. (WARNINGS)". 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 BLOOD CLOTTING. WHILE ON CPB THE PERFUTIONIST OBSERVERED THE CLOT IN THE OXYGENATOR RESERVOIR. THE OXYGENATOR WAS NOT REPLACED AND THE PROCEDURE WAS CONTINUED AS NORMAL. NO EVENT WAS REPORTED. THE PROCEDURE OUTCOME WAS NOT REPORTED. THERE WAS NO HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    828852 CAPIOX FX25 OXYGENATOR, CARDIOPULMONARY BYPASS DTZ TERUMO MEDICAL CORPORATION N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Male