BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPIOX FX OXYGENATOR

    MDR report key: 7393255 · Received April 3, 2018

    Report

    Report Number
    9681834-2018-00040
    Event Type
    Malfunction
    Date Received
    April 3, 2018
    Date of Event
    March 14, 2018
    Report Date
    April 3, 2018
    Manufacturer
    TERUMO CORPORATION, ASHITAKA
    Product Code
    DTZ
    PMA / PMN Number
    K071494
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    D6: IMPLANTED DATE: DEVICE WAS NOT IMPLANTED D7: EXPLANTED DATE: DEVICE WAS NOT EXPLANTED G5: 510K - K130520 THE ACTUAL DEVICE WAS RETURNED FOR EVALUATION. VISUAL INSPECTION REVEALED THE SAMPLING LINE TUBE HAD BEEN FLATTENED. A REVIEW OF THE DEVICE HISTORY RECORD AND SHIPPING INSPECTION RECORD OF THE INVOLVED PRODUCT CODE/LOT NUMBER COMBINATION REVEALED THERE WERE NO INDICATION OF PRODUCTION RELATED ANOMALIES. HOWEVER, IT WAS FOUND THERE WAS A NEW ASSOCIATE PACKAGING THE DEVICE. THERE IS NO EVIDENCE THAT THIS EVENT WAS RELATED TO A DEVICE DEFECT OR MALFUNCTION. HOWEVER, THE INVESTIGATION FOUND THAT THE TRAINING OF A NEW ASSOCIATE FOR THE PROPER POSITIONING OF THE SAMPLING LINE TUBE IN THE PACKAGE HAD BEEN INSUFFICIENT. DUE TO THIS, THE SAMPLING LINE TUBE OF THE ACTUAL DEVICE WAS ACCIDENTALLY SANDWICHED BETWEEN THE DEVICE AND THE CUSHION MATERIAL DURING THE NEW ASSOCIATES PACKAGING WORK, RESULTING IN THE REPORTED DEFORMATION OF THE SAMPLING LINE TUBE. 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.

    Description of Event or Problem · 0

    THE USER FACILITY REPORTED DURING PREPARATION, THE SAMPLING LINE TUBE WAS FOUND TO HAVE BEEN FLATTENED. THE PROCEDURE OUTCOME AND PATIENT CONDITION WAS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    237462 CAPIOX FX OXYGENATOR OXYGENATOR, CARDIOPULMONARY BYPASS DTZ TERUMO CORPORATION, ASHITAKA NA 180129

    Patients

    Seq Age Sex Outcome Treatment
    1