BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPIOX FX OXYGENATOR

    MDR report key: 10137112 · Received June 10, 2020

    Report

    Report Number
    9681834-2020-00088
    Event Type
    Malfunction
    Date Received
    June 10, 2020
    Date of Event
    May 11, 2020
    Report Date
    June 10, 2020
    Manufacturer
    TERUMO CORPORATION, ASHITAKA
    Product Code
    DTZ
    PMA / PMN Number
    K071494
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    IMPLANTED DATE: DEVICE WAS NOT IMPLANTED. EXPLANTED DATE: DEVICE WAS NOT EXPLANTED. 510K - K130520. THE ACTUAL DEVICE INCLUDING THE LUER THERMISTOR WAS RECEIVED FOR EVALUATION. VISUAL INSPECTION REVEALED NO BREAK OR ANY OTHER ANOMALY IN THE APPEARANCE. THE ACTUAL SAMPLE AFTER RINSED WAS BUILT INTO A TEST CIRCUIT AND CIRCULATED WITH 37°C-TEMPERATURE WATER, AND THE TEMPERATURE-READING ACCURACY OF EACH LUER THERMISTOR WAS EVALUATED. THE READING ACCURACY OF ALL THE THERMISTOR WAS CONFIRMED TO MEET THE MANUFACTURER SPECIFICATIONS AND NO ANOMALY WAS OBSERVED. A REVIEW OF THE DEVICE HISTORY RECORD AND PRODUCT RELEASE DECISION CONTROL SHEET OF THE INVOLVED PRODUCT CODE/LOT# COMBINATION WAS CONDUCTED WITH NO FINDINGS. BASED ON THE PROVIDED INFORMATION AND INVESTIGATION RESULTS, THERE IS NO DEFINITIVE EVIDENCE THAT THIS EVENT WAS RELATED TO A DEVICE DEFECT OR MALFUNCTION. THE INVESTIGATION RESULTS VERIFIED THE RETURNED SAMPLE WAS OF THE NORMAL PRODUCT. THE EXACT CAUSE OF THE REPORTED EVENT CANNOT BE DEFINITIVELY DETERMINED BASED ON THE AVAILABLE INFORMATION. (B)(4).

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT THE INVOLVED CAPIOX CUSTOM PACK WAS USED PRE-TREATMENT. DURING A PRIMING WITH THE TEMPERATURE SET TO 36°C, THE VENOUS BLOOD TEMPERATURE WAS SHOWN AS 35.5°C WHEREAS THE ARTERIAL TEMPERATURE WAS SHOWN 34.7°C - 35.2°C. THIS PHENOMENON OCCURRED AFTER THE S5 MODULE WAS CHANGED. THEY STOPPED USING THE ACTUAL SAMPLE AND PREPARED A REPLACEMENT TO CONTINUE THE CASE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    602062 CAPIOX FX OXYGENATOR OXYGENATOR, CARDIOPULMONARY BYPASS DTZ TERUMO CORPORATION, ASHITAKA NA 190911

    Patients

    Seq Age Sex Outcome Treatment
    1