BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPIOX FX OXYGENATOR

    MDR report key: 6766418 · Received August 4, 2017

    Report

    Report Number
    9681834-2017-00160
    Event Type
    Malfunction
    Date Received
    August 4, 2017
    Date of Event
    July 7, 2017
    Report Date
    August 4, 2017
    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

    D4 - UDI NUMBER FOR THE PRODUCT CODE IS NOT REQUIRED. THE ACTUAL DEVICE HAS BEEN RETURNED TO THE MANUFACTURING FACILITY FOR EVALUATION. VISUAL AND MAGNIFYING INSPECTIONS FOUND A BREAK WHICH IMPLIED THE ACTUAL SAMPLE WAS DISTORTED AND RIPPED OFF. BASED ON THE COMPLAINT DESCRIPTION, IT IS ASSUMABLE THAT THE ACTUAL SAMPLE WAS DETACHED FROM THE MAIN BODY FORCEFULLY. THIS BREAK SEEMED TO HAVE NOTHING TO DO WITH THE REPORTED ISSUE. X RAY FLUOROSCOPIC INSPECTION DID NOT REVEAL ANY ANOMALIES SUCH AS A BREAK ON THE LEAD WIRE. A REVIEW OF THE DEVICE HISTORY RECORD AND PRODUCT RELEASE DECISION CONTROL SHEET OF THE INVOLVED PRODUCT CODE/LOT NUMBER COMBINATION WAS CONDUCTED WITH NO RELEVANT FINDINGS. A SEARCH OF THE COMPLAINT FILE FOUND ONE OTHER REPORT OF THIS NATURE FROM THE SAME FACILITY. SEE MDR NUMBER 9681834-2017-00161. THERE IS NO EVIDENCE THIS EVENT WAS RELATED TO A DEVICE DEFECT OR MALFUNCTION. SINCE THE ACTUAL SAMPLE WAS RETURNED TO ASHITAKA IN THE BROKEN STATE, IT WAS NOT POSSIBLE TO COMPLETE AN EVALUATION FROM THE VIEW POINT OF ITS TEMPERATURE DETERMINATION PERFORMANCE. 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. ALL AVAILABLE INFORMATION HAS BEEN PLACED ON FILE IN QUALITY ASSURANCE AT THE MANUFACTURING FACILITY FOR APPROPRIATE TRACKING, TRENDING AND FOLLOW-UP.

    Description of Event or Problem · 0

    THE USER FACILITY REPORTED AN UNEXPECTED VALUE IN THE TEMP OF THE CAPIOX DEVICE DURING A PROCEDURE. FOLLOW UP COMMUNICATION WITH THE USER FACILITY PROVIDED THE FOLLOWING INFORMATION: THE CAPIOX DEVICE WITH LOT NUMBER 170131 SHOWED AN UNEXPECTED VALUE IN THE ARTERIAL TEMPERATURE WITH SOME VARIATION; THE CUSTOMER CHANGED OUT 170131 TO 170330; THE ISSUE WAS NOT SOLVED, THE CUSTOMER FOUND THAT WHEN CONTACT WAS MADE WITH THE BASE OF THE CABLE JACK THE INDICATED VALUES VARIED; AND THE CUSTOMER CONTINUED THE EXTRACORPOREAL CIRCULATION SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    549132 CAPIOX FX OXYGENATOR OXYGENATOR, CARDIOPULMONARY BYPASS DTZ TERUMO CORPORATION, ASHITAKA NA 170131

    Patients

    Seq Age Sex Outcome Treatment
    1 SENKO CENTRIFUGAL BLOOD PUMP MACHINE| SENKO CENTRIFUGAL BLOOD PUMP MACHINE