BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPIOX FX25 OXYGENATOR

    MDR report key: 18160996 · Received November 17, 2023

    Report

    Report Number
    9681834-2023-00220
    Event Type
    Malfunction
    Date Received
    November 17, 2023
    Date of Event
    October 23, 2023
    Report Date
    November 17, 2023
    Manufacturer
    TERUMO MEDICAL CORPORATION
    Product Code
    DTZ
    PMA / PMN Number
    K071572
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    G4: PMA/510(K): K130280; E3: OCCUPATION: CLINICAL ENGINEER. VISUAL INSPECTION OF THE THERMISTOR PROBES OF OXYGENATOR AND OF THE RESERVOIR OBTAINED THE FOLLOWING RESULT. THERE WAS NO ANOMALY SUCH AS A BREAKAGE. NO ANOMALY IN THE CONDITION OF ADHESION BETWEEN THE THERMISTOR PROBES AND THE PORTS. THE ACTUAL SAMPLE (AFTER CLEANING) WAS INCORPORATED INTO A CIRCUIT CONSISTING OF TUBING. WHILE SALINE SOLUTION WAS CIRCULATED THROUGH THE BLOOD CHANNEL, 37°C WARM WATER WAS FLOWED INTO THE HEAT EXCHANGER. THE DISPLAYED TEMPERATURE WAS COMPARABLE TO THAT READ WITH A CURRENT PRODUCT AND NO ANOMALY WAS OBSERVED. 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 RESULTS, NO ANOMALY WAS FOUND IN EACH THERMISTOR PROBE OF THE ACTUAL SAMPLE, AND THE CAUSE OF THE OCCURRENCE OF THIS CASE COULD NOT BE CLARIFIED. RELEVANT INSTRUCTIONS FOR USE (IFU) REFERENCE: "DO NOT USE IF THE PACKAGE OR DEVICE IS DAMAGED (E.G. CRACKED) OR ANY OF THE PORT CAPS ARE OFF." 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 THAT THE ARTERIAL BLOOD TEMPERATURE AND VENOUS BLOOD TEMPERATURE ON THE DISPLAY WERE UNSTABLE AND DISORDERED. THE PROBLEM PERSISTED EVEN AFTER THE THERMISTOR CABLES WERE REPLACED WITH NEW ONES. THE PUMP CHART SHOWED THAT VENOUS BLOOD TEMPERATURE WAS UNSTABLE, INCLUDING FROM 11:16 TO 11:19, AND THE ARTERIAL BLOOD TEMPERATURE WAS OBSERVED UNSTABLE AROUND 14:36. THE THERMISTOR CABLES WERE REPLACED WITH NEW ONES. THE SURGERY CONTINUED AND WAS COMPLETED SUCCESSFULLY. THE FINAL PATIENT IMPACT WAS NOT HARMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1745286 CAPIOX FX25 OXYGENATOR OXYGENATOR, CARDIOPULMONARY BYPASS DTZ TERUMO MEDICAL CORPORATION N/A 230525

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown