BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPIOX®FX

    MDR report key: 20959359 · Received December 17, 2024

    Report

    Report Number
    9681834-2024-00229
    Event Type
    Injury
    Date Received
    December 17, 2024
    Date of Event
    November 20, 2024
    Report Date
    December 17, 2024
    Manufacturer
    TERUMO CORPORATION, ASHITAKA
    Product Code
    DTZ
    PMA / PMN Number
    K071494
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A1: PATIENT IDENTIFIER: REQUESTED, NOT PROVIDED . A2: DATE OF BIRTH: REQUESTED, NOT PROVIDED. A3B: GENDER: REQUESTED, NOT PROVIDED. A4: WEIGHT: REQUESTED, NOT PROVIDED . A5: ETHNICITY: REQUESTED, NOT PROVIDED. A6: RACE: REQUESTED, NOT PROVIDED. D6A: IMPLANTED DATE: DEVICE WAS NOT IMPLANTED. D6B: EXPLANTED DATE: DEVICE WAS NOT EXPLANTED. E1: REPORTER NAME: REQUESTED, UNKNOWN. E1: PHONE NUMBER: REQUESTED, UNKNOWN. G4: PMA/510(K): K130520. THE ACTUAL SAMPLES WERE NOT RETURNED. CONFIRMATION OF THE PROVIDED IMAGE: FORMATION OF BLOOD CLOTS WAS OBSERVED ON THE DEFOAMER OF THE VENOUS FILTER INSIDE THE RESERVOIR. THE MANUFACTURING HISTORY RECORD AND THE SHIPPING INSPECTION RECORD OF THE ACTUAL SAMPLE SHOWED NO ANOMALIES. ADDITIONALLY, THE PAST COMPLAINT FILE FOR THE PRODUCT CODE INVOLVED AND LOT NUMBER INDICATED NO SIMILAR COMPLAINTS WERE RECEIVED. BASED ON OUR PAST EXPERIENCE, IT WAS INFERRED THAT THE FOLLOWING FACTORS COULD HAVE COMBINED TO CAUSE THE REPORTED ISSUE; HOWEVER, THE ACTUAL SAMPLES COULD NOT BE CONFIRMED, AND THE CAUSE OF OCCURRENCE COULD NOT BE CLARIFIED. OUR RESERVOIR IS SPECIFICALLY DESIGNED TO PROVIDE STRUCTURAL STABILITY TO THE LIQUID SURFACE OF STORED BLOOD, FACILITATING EASIER MANAGEMENT OF THE LIQUID LEVEL. HOWEVER, ON THE OTHER HAND, THIS ALSO MAKES IT DIFFICULT TO AGITATE THE BLOOD WITHIN. IN THIS PARTICULAR CASE, IT WAS INFERRED THAT BLOOD CONTAINING ACTIVATED BLOOD-CLOTTING FACTORS MIGHT HAVE FLOWED INTO THE RESERVOIR AND REMAINED AT THE LIQUID LEVEL, LEADING TO THE FORMATION OF BLOOD CLOTS. RELEVANT INSTRUCTIONS FOR USE (IFU) REFERENCE: DO NOT REDUCE HEPARIN DURING CIRCULATION. OTHERWISE, BLOOD CLOTTING MIGHT OCCUR. ADEQUATE HEPARINIZATION OF THE BLOOD IS REQUIRED CONSIDERING PATIENT CONDITION AND PERFUSION TECHNIQUE TO PREVENT IT FROM CLOTTING IN THE SYSTEM. THIS REPORT IS FOR THE FIRST DEVICE REPORTED. FOR THE SECOND DEVICE USED ON THE SAME PATIENT, PLEASE REFER TO THE RELATED REPORT NUMBER IN SECTION H10. 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 DURING A LEFT VENTRICULAR ASSIST DEVICE (LVAD) IMPLANTATION AND CARDIOPULMONARY BYPASS (CPB), NUMEROUS BLOOD CLOTS APPEARED IN THE VENOUS RESERVOIR (VR). AFTER REPLACING IT WITH A NEW FX25RW, THE BLOOD CLOTS CONTINUED TO APPEAR. THIS WAS JUDGED AS A SERIOUS INJURY DUE TO THE PRODUCT CHANGE. THE PATIENT WAS NOT HARMED. THE EVENT OCCURRED INTRA-OPERATIVELY, AND MEDICAL/SURGICAL INTERVENTION WAS REQUIRED TO PREVENT INJURY OR BLOOD LOSS, INCLUDING ANY LOSS DURING THE PRODUCT CHANGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    259089 CAPIOX®FX OXYGENATOR, CARDIOPULMONARY BYPASS DTZ TERUMO CORPORATION, ASHITAKA CX*FX25RW 240625

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Male Other