BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPIOX FX25 OXYGENATOR

    MDR report key: 10307923 · Received July 22, 2020

    Report

    Report Number
    9681834-2020-00137
    Event Type
    Injury
    Date Received
    July 22, 2020
    Date of Event
    June 4, 2020
    Report Date
    July 22, 2020
    Manufacturer
    TERUMO CORPORATION, ASHITAKA
    Product Code
    DTZ
    PMA / PMN Number
    K071494
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IMPLANTED DATE: DEVICE WAS NOT IMPLANTED. EXPLANTED DATE: DEVICE WAS NOT EXPLANTED. PMA/510(K) - K130280. THE ACTUAL DEVICE WAS NOT RETURNED; THEREFORE, AN EVALUATION OF THE ACTUAL DEVICE WAS UNABLE TO BE CONDUCTED. 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. REVIEW OF THE SHIPPING INSPECTION RECORD OF THE INVOLVED FIBER LOT CONFIRMED THAT THE GAS TRANSFER PERFORMANCE TEST AND PRESSURE DROP TEST RESULTS MET THE MANUFACTURER CONTROL CRITERIA AND NO ANOMALY WAS NOTED. IT IS LIKELY THAT POST-OPERATIVE HEMATURIA URINE APPEARED BECAUSE HEMOLYSIS MIGHT HAVE OCCURRED DUE TO SOME FACTORS. HOWEVER, WITH NO RETURN OF THE ACTUAL DEVICE, 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 DEVICE WAS USED DURING THE PROCEDURE. POST-OPERATIVE HEMATURIA URINE WAS FOUND WHEN THE PATIENT WAS TRANSFERRED FROM THE OPERATING TABLE TO HIS BED. DURING THE BYPASS THE URINE IS SMALL; HOWEVER, CLEAR. THE BYPASS LASTED 2 HOURS AND 28 MINUTES WITHOUT ANY PARTICULAR CONCERN EXCEPT FOR SOME UNEXPLAINED HEMODYNAMIC PROBLEMS (VARIATION OF BLOOD PRESSURE) TRANSMITTED TO THE ANESTHETIST. PROBABLE HEMOLYSIS. THE PATIENT IMPACT AND PROCEDURE OUTCOME WERE NOT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    771259 CAPIOX FX25 OXYGENATOR OXYGENATOR, CARDIOPULMONARY BYPASS DTZ TERUMO CORPORATION, ASHITAKA NA 190705

    Patients

    Seq Age Sex Outcome Treatment
    1 Other