BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNK CAPIOX ARTERIAL FILTER

    MDR report key: 8491341 · Received April 8, 2019

    Report

    Report Number
    9681834-2019-00049
    Event Type
    Malfunction
    Date Received
    April 8, 2019
    Date of Event
    March 13, 2019
    Report Date
    April 8, 2019
    Manufacturer
    TERUMO CORPORATION, ASHITAKA
    Product Code
    DTM
    PMA / PMN Number
    K052205
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    D6: IMPLANTED DATE: DEVICE WAS NOT IMPLANTED D7: EXPLANTED DATE: DEVICE WAS NOT EXPLANTED G4: 510(K): K943917 THE ACTUAL DEVICE WAS NOT RETURNED; THEREFORE, AN EVALUATION OF THE ACTUAL DEVICE WAS UNABLE TO BE CONDUCTED. THE PRODUCTION PRODUCT CODE/LOT NUMBER COMBINATION WAS NOT PROVIDED BY THE USER FACILITY, WHICH PREVENTED A MEANINGFUL REVIEW OF THE DEVICE HISTORY RECORD. WITH NO RETURN OF THE ACTUAL DEVICE, THE EXACT CAUSE OF THE REPORTED EVENT CANNOT BE DEFINITIVELY DETERMINED BASED ON THE AVAILABLE INFORMATION. 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 THAT THE KEY OF THE TRACKS THAT COMES WITH THE CAPIOX ARTERIAL FILTER PRESENTS LEAKS. THE ACTUAL SAMPLE WAS CHANGED OUT. THERE WAS NO IMMEDIATE PATIENT IMPACT. THE PROCEDURE OUTCOME AND FINAL PATIENT IMPACT WAS REPORTED TO BE UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    285604 UNK CAPIOX ARTERIAL FILTER FILTER, BLOOD, CARDIOPULMONARY BYPASS, ARTERIAL LINE DTM TERUMO CORPORATION, ASHITAKA NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1