BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPIOX FX OXYGENATOR

    MDR report key: 7331827 · Received March 12, 2018

    Report

    Report Number
    9681834-2018-00024
    Event Type
    Injury
    Date Received
    March 12, 2018
    Date of Event
    July 26, 2017
    Report Date
    March 12, 2018
    Manufacturer
    TERUMO CORPORATION, ASHITAKA
    Product Code
    DTZ
    PMA / PMN Number
    K071494
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    D6: IMPLANTED DATE: DEVICE WAS NOT IMPLANTED D7: EXPLANTED DATE: DEVICE WAS NOT EXPLANTED G.5 - 510(K): K130520 THE ACTUAL DEVICE WAS NOT RETURNED; THEREFORE, AN EVALUATION OF THE ACTUAL DEVICE WAS UNABLE TO BE CONDUCTED. A RETENTION SAMPLE WAS EVALUATED. VISUAL INSPECTION REVEALED NO ANOMALIES. THE SAMPLE WAS BUILT INTO A CIRCUIT. BOVINE BLOOD (HCT @35% TEMP.@37OC) WAS CIRCULATED IN THE CIRCUIT WHILE THE PRESSURE DROP WAS DETERMINED. IT WAS VERIFIED TO MEET THE SPECIFICATIONS. THE RETENTION SAMPLE FROM THE INVOLVED PRODUCT CODE/LOT# COMBINATION WAS CONFIRMED TO BE THE NORMAL PRODUCT. WITH NO DEVICE RETURN THE EXACT CAUSE OF THE REPORTED EVENT CANNOT BE DEFINITIVELY DETERMINED BASED ON THE AVAILABLE INFORMATION. A REVIEW OF THE DEVICE HISTORY RECORD AND SHIPPING INSPECTION RECORD OF THE INVOLVED PRODUCT CODE/LOT NUMBER COMBINATION REVEALED NO FINDINGS. THE IFU STATES: DO NOT REDUCE HEPARIN DURING CIRCULATION. OTHERWISE, BLOOD CLOTTING MIGHT OCCUR ADEQUATE HEPARINIZATION OF THE BLOOD IS REQUIRED TO PREVENT IT FROM CLOTTING IN THE SYSTEM. TERUMO MEDICAL PRODUCTS (TMP) (IMPORTER) REGISTRATION NO. 2243441 IS SUBMITTING THIS REPORT ON BEHALF OF ASHITAKA FACTORY OF TERUMO CORPORATION (MANUFACTURER) REGISTRATION NO. 9681834. EXEMPTION NUMBER E2015022.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED AS FOLLOW UP NO. 1 TO PROVIDE ADDITIONAL INFORMATION IN SECTION B5. SECTION H6: PATIENT CODE HAS BEEN UPDATED BASED OFF THE ADDITIONAL INFORMATION PROVIDED.

    Description of Event or Problem · 0

    THE USER FACILITY REPORTED THE OXYGENATOR'S INPUT PRESSURE INCREASED TO MORE THAN 650 MMHG, OXYGENATION BORDERLINE, AND CO COULD NOT BE HELD UPRIGHT. INTRAOPERATIVE EXCHANGE OF THE OXYGENATOR. POTENTIAL PATIENT DAMAGE NOT YET FORESEEABLE.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION WAS RECEIVED ON APRIL 6, 2018. IT WAS REPORTED THERE WAS NO HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    174607 CAPIOX FX OXYGENATOR OXYGENATOR, CARDIOPULMONARY BYPASS DTZ TERUMO CORPORATION, ASHITAKA NA 160825

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention