BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPIOX FX05 OXYGENATOR

    MDR report key: 16513599 · Received March 9, 2023

    Report

    Report Number
    9681834-2023-00038
    Event Type
    Malfunction
    Date Received
    March 9, 2023
    Date of Event
    February 6, 2023
    Report Date
    March 8, 2023
    Manufacturer
    TERUMO CORPORATION, ASHITAKA
    Product Code
    DTZ
    UDI-DI
    04987350781772
    PMA / PMN Number
    K071572
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    IMPLANTED DATE: REQUESTED, NOT PROVIDED. EXPLANTED DATE: REQUESTED, NOT PROVIDED. INITIAL REPORTER COUNTRY: PALESTINE. INITIAL REPORTER TELEPHONE NUMBER: (B)(6). INITIAL REPORTER OCCUPATION: PERFUSIONIST. PMA/510(K) - K130280. REVIEW OF THE MANUFACTURING RECORD AND SHIPPING INSPECTION RECORD OF THE ACTUAL SAMPLE FOUND NO ANOMALY IN THEM. A SEARCH OF THE PAST COMPLAINT FILE FOUND NO OTHER SIMILAR INDICATIONS REGARDING THE INVOLVED PRODUCT CODE/LOT. THE ACTUAL SAMPLED WAS DISCARDED BY THE INVOLVED FACILITY. SINCE THE ACTUAL SAMPLE WAS NOT RETURNED, INVESTIGATION OF IT COULD NOT BE PERFORMED. ACCORDING TO THE INVESTIGATION RESULT, NO ANOMALY WAS FOUND IN THE MANUFACTURING RECORDS. FROM THE ADDITIONAL INFORMATION THAT THE GAS LINE WAS CONNECTED CORRECTLY TO THE OXYGENATOR, AS A CAUSE OF THE DARK BLOOD OBSERVED DURING PRIMING, A POSSIBILITY WAS CONSIDERED THAT THE BLOOD WAS NOT OXYGENATED DUE TO SOME FACTORS. HOWEVER, IT WAS NOT POSSIBLE TO CONFIRM THE ACTUAL SAMPLE, AND THE CAUSE COULD NOT BE CLARIFIED. IFU STATES: "MEASURE BLOOD GASES AND MAKE NECESSARY ADJUSTMENTS AS FOLLOWS. (D.DURING PERFUSION) A. CONTROL PAO2 BY CHANGING CONCENTRATION OF OXYGEN IN VENTILATING GAS USING GAS BLENDER. TO DECREASE PAO2, DECREASE FIO2. TO INCREASE PAO2, INCREASE FIO2." 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 TECHNICAL ISSUES IN A PROCEDURE FOR ATRIOVENTRICULAR (AV) CANAL DISEASE ON A CARDIOPULMONARY BYPASS MACHINE, AND DURING THE PRIMING WITH BLOOD BEFORE THE SURGERY AS A ROUTINE WE NOTE A DARK BLOOD IN THE PRIMING. THEY REPLACED THE OXYGENATOR IMMEDIATELY. THE GAS FLOW WAS TURNED ON AND THE GAS LINE WAS CONNECTED TO OXYGENATOR CORRECTLY. THE PRIMING COMPOSITION WAS NORMAL SALINE (NS)/RED BLOOD CELLS (RBC)/FRESH FROZEN PLASMA (FFP). A BLOOD GAS WAS PERFORMED. THE PO2 OF THE BLOOD WAS ANALYZED TO VALIDATE AND WAS PO2 30%. THE PERFUSIONIST PUT THE OXYGENATOR ON HEPARIN FORMULA. THE PROCEDURE OUTCOME WAS NOT REPORTED. THE PATIENT WAS NOT HARMED. IT IS UNKNOWN IF THERE WERE ANY OTHER DEVICES OR EQUIPMENT USED WITH THE REPORTED PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    660140 CAPIOX FX05 OXYGENATOR OXYGENATOR, CARDIOPULMONARY BYPASS DTZ TERUMO CORPORATION, ASHITAKA N/A 220112 04987350781772

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Hospitalization