BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPIOX®RX

    MDR report key: 20878123 · Received December 9, 2024

    Report

    Report Number
    9681834-2024-00224
    Event Type
    Injury
    Date Received
    December 9, 2024
    Date of Event
    November 13, 2024
    Report Date
    December 9, 2024
    Manufacturer
    TERUMO CORPORATION, ASHITAKA
    Product Code
    DTZ
    UDI-DI
    04987350763471
    PMA / PMN Number
    K022115
    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. 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: INITIAL REPORTER NAME: REQUESTED, UNKNOWN. E1: PHONE NUMBER: REQUESTED, UNKNOWN. G4: PMA/510(K): K130493. THE ACTUAL SAMPLE WAS NOT RETURNED. CONFIRMATION OF THE PROVIDED IMAGE: IT WAS FOUND THAT AIR WAS MIXED INTO THE TOP SURFACE OF OXYGENATOR. FROM THE IMAGE, IT WAS INFERRED THAT IT WAS TIME TO REPLACE THE PRIMING FLUID WITH BLOOD. THE MANUFACTURING RECORD AND THE SHIPPING INSPECTION RECORD OF THE ACTUAL SAMPLE FOUND NO ANOMALY. NO OTHER SIMILAR REPORT OF THE PRODUCT WITH THE INVOLVED PRODUCT CODE/LOT NUMBER WAS FOUND. BASED ON THE INVESTIGATION RESULT, NO ANOMALY WAS FOUND IN THE MANUFACTURING RECORDS. BASED ON THE PROVIDED IMAGE, IT WAS LIKELY THAT AIR WAS MIXED WHEN REPLACING THE PRIMING FLUID WITH BLOOD. DUE TO THIS, IT WAS INFERRED THAT AIR WAS FLOWED INTO THE OXYGENATOR FOR SOME FACTOR, OR THAT AIR REMAINED IN THE OXYGENATOR DURING PRIMING. HOWEVER, SINCE THE ACTUAL SAMPLE COULD NOT BE CONFIRMED, IT WAS NOT POSSIBLE TO CLARIFY THE CAUSE OF OCCURRENCE. RELEVANT INSTRUCTIONS FOR USE (IFU) REFERENCE: "ENSURE THAT THE DE-AIRING PROCESS IS COMPLETE PRIOR TO INITIATING BYPASS." "DURING RECIRCULATION, DO NOT USE PULSATILE FLOW AND DO NOT STOP THE BLOOD PUMP SUDDENLY AS THESE ACTIONS MAY CAUSE GASEOUS EMBOLI TO ENTER THE BLOOD PHASE FROM THE GAS PHASE DUE TO INERTIA FORCE." "DO NOT OBSTRUCT GAS OUTLET PORT. AVOID BUILDUP OF EXCESS PRESSURE IN THE GAS PHASE TO PREVENT GASEOUS EMBOLI ENTERING THE BLOOD PHASE." "PRESSURE IN THE BLOOD PHASE SHOULD ALWAYS BE HIGHER THAN THAT IN THE GAS PHASE TO PREVENT GASEOUS EMBOLI ENTERING THE BLOOD PHASE." "THE GAS FLOW RATE SHOULD NOT EXCEED 5L/MIN. EXCESSIVE GAS FLOW RATE WILL BRING ABOUT PRESSURE INCREASE IN THE GAS PHASE, ALLOWING GASEOUS EMBOLI TO ENTER THE BLOOD PHASE." "TO PREVENT GASEOUS EMBOLI FROM ENTERING THE BLOOD PHASE, MAKE SURE THAT THE ARTERIAL PUMP FLOW RATE ALWAYS EXCEEDS THE FLOW RATE OF THE CARDIOPLEGIA LINE. THE BLOOD FLOW RATE OF THE CARDIOPLEGIA LINE SHOULD NOT EXCEED 0.5L/MIN." "RECIRCULATE THE PRIMING SOLUTION AT A RATE OF 0.5 L/MIN OR HIGHER TO FACILITATE AIR REMOVAL." 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 AS SOON AS CPB START, THE AIR BUBBLES WERE FOUND AND COULD NOT BE REMOVED. A NEW DEVICE WAS PLACED TO COMPLETE THE PROCEDURE. THERE WAS NO HEALTH HAZARD TO THE PATIENT. THE PROCEDURE OUTCOME WAS NOT REPORTED. THE PATIENT WAS NOT HARMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    132649 CAPIOX®RX OXYGENATOR, CARDIOPULMONARY BYPASS DTZ TERUMO CORPORATION, ASHITAKA CX*RX05RW 240311 04987350763471

    Patients

    Seq Age Sex Outcome Treatment
    1 3 YR Male Other