BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPIOX FX 15 HOLLOW FIBER OXYGENATOR AF

    MDR report key: 5840971 · Received August 2, 2016

    Report

    Report Number
    9681834-2016-00191
    Event Type
    Malfunction
    Date Received
    August 2, 2016
    Date of Event
    July 7, 2016
    Report Date
    August 2, 2016
    Manufacturer
    TERUMO CORPORATION, ASHITAKA
    Product Code
    DTZ
    UDI-DI
    04987350701206
    PMA / PMN Number
    K071494
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE ACTUAL DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURING FACILITY FOR EVALUATION. FOR THIS REASON, EVALUATION CODE 11 WAS USED IN THE CONCLUSIONS SECTION OF H6. A FOLLOW UP REPORT WILL BE SUBMITTED WITHIN 30 DAYS OF THIS REPORT BEING SENT. A REVIEW OF THE DEVICE HISTORY RECORD AND THE PRODUCT RELEASE DECISION CONTROL SHEET OF THE INVOLVED PRODUCT/LOT # COMBINATION WAS CONDUCTED WITH NO RELEVANT FINDINGS. A SEARCH OF THE COMPLAINT FILE DID NOT FIND ANY OTHER REPORT WITH THE INVOLVED PRODUCT CODE/LOT# COMBINATION. 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 FOR APPROPRIATE TRACKING, TRENDING AND FOLLOW-UP. H3 OTHER TEXT : DEVICE NOT RETURNED TO MANUFACTURER

    Description of Event or Problem · 0

    THE USER FACILITY REPORTED A TUBE FRACTURE ON THE CAPIOX FX15 DEVICE DURING PRIME. FOLLOW UP COMMUNICATION WITH THE USER FACILITY CONFIRMED THE FOLLOWING INFORMATION: THE ONE WAY VALVE LINE CONNECTED TO THE OXYGENATOR LOOKS LIKE IT HAD BEEN SEVERED; THE PRODUCT WAS CHANGED OUT; THE SURGERY WAS COMPLETED SUCCESSFULLY; AND THERE WAS NO PATIENT INVOLVEMENT.

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING SUBMITTED AS FOLLOW UP # 1 TO PROVIDE THE RETURNED SAMPLE EVALUATION RESULTS. THE ACTUAL DEVICE WAS RETURNED TO THE MANUFACTURING FACILITY FOR EVALUATION. VISUAL INSPECTION CONFIRMED THE CUSTOMER'S OBSERVATION. THE PURGE LINE TUBE HAD BEEN ALMOST FRACTURED AT THE JOINT WITH THE PORT. ELECTRON MICROSCOPIC INSPECTIONS OF THE FRACTURE CROSS-SECTIONS OF THE TUBE FOUND THAT SOME SEGMENTS WERE IN THE SMOOTH STATE AND OTHER SEGMENTS IN THE ROUGH STATE. IT WAS NOTED THAT SOME STREAKS WERE GENERATED STARTING FROM THE SMOOTH SURFACE TOWARD THE ROUGH SURFACE. THE TUBE WAS CUT VERTICALLY AND WAS SUBJECTED TO ANOTHER VISUAL INSPECTION REVEALING NO DEFECTS, WITH THE TUBE IN THE INTACT STATE. SIMULATION TESTING WAS CONDUCTED ON A CURRENT PRODUCT SAMPLE. A CURRENT PRODUCT SAMPLE WAS EXPOSED TO A SHOCK FORCE AT THE JOINT OF THE PURGE LINE TUBE AND THE PORT AFTER BEING LEFT UNDER A LOW TEMPERATURE OF 4°C. THE SAMPLING LINE TUBE BECAME FRACTURED AT THE JOINT. ELECTRON MICROSCOPIC INSPECTION OF THE FRACTURED CROSS-SECTION FOUND THAT THE STATE OF THE SURFACE WAS SIMILAR TO THAT OF THE ACTUAL SAMPLE. A REVIEW OF THE DEVICE HISTORY RECORD OF THE INVOLVED PRODUCT CODE/LOT# COMBINATION WAS CONDUCTED WITH NO RELEVANT FINDINGS. A SEARCH OF THE COMPLAINT FILE FOUND NO OTHER REPORT WITH THE INVOLVED PRODUCT CODE/LOT# COMBINATION. THERE IS NO EVIDENCE THAT THIS EVENT WAS RELATED TO A DEVICE DEFECT OR MALFUNCTION. ALTHOUGH THE EXACT CAUSE CANNOT BE DEFINITIVELY DETERMINED BASED ON THE INVESTIGATION RESULTS, IT IS LIKELY THE ACTUAL SAMPLE WAS SUBJECTED TO A SHOCK FORCE. THE DEVICE LABELING DOES ADDRESS THE POTENTIAL FOR SUCH AN EVENT IN THE INSTRUCTIONS-FOR-USE (IFU): "DO NOT USE IF THE PACKAGE OR DEVICE IS DAMAGED (E.G. CRACKED) OR ANY OF THE PART CAPS ARE OFF. DO NOT USE AN OXYGENATOR THAT LEAKS." ALL AVAILABLE INFORMATION HAS BEEN PLACED ON FILE IN QUALITY ASSURANCE FOR APPROPRIATE TRACKING, TRENDING AND FOLLOW-UP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    492010 CAPIOX FX 15 HOLLOW FIBER OXYGENATOR AF OXYGENATOR DTZ TERUMO CORPORATION, ASHITAKA NA 151216 04987350701206

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization