BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPIOX FX 15 HOLLOW FIBER OXYGENATOR AF

    MDR report key: 4854076 · Received June 18, 2015

    Report

    Report Number
    9681834-2015-00118
    Event Type
    Malfunction
    Date Received
    June 18, 2015
    Date of Event
    May 29, 2015
    Report Date
    June 18, 2015
    Manufacturer
    TERUMO CORPORATION, ASHITAKA
    Product Code
    DTZ
    PMA / PMN Number
    K071494
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING SUBMITTED AS FOLLOW-UP #2 FOR MFG. REPORT # 9681834-2015-00118 TO PROVIDE THE RETURN SAMPLE EVALUATION RESULTS AND TO PROVIDE THE CORRECT LOT NUMBER THE DEVICE MANUFACTURING DATE. THE ACTUAL SAMPLE WAS RETURNED TO THE MANUFACTURING FACILITY FOR EVALUATION. VISUAL INSPECTION UPON RECEIPT FOUND NO ANOMALIES OR DEFECTS. VISUAL INSPECTION UPON RECEIPT FOUND THAT ITS LOT NUMBER WAS ORIGINALLY REPORTED 141010 BUT WAS FOUND TO BE 141017. IT WAS ALSO FOUND THAT THE ACTUAL SAMPLE IS THE SINGLE OXYGENATOR TYPE WITHOUT A HARD SHELL RESERVOIR, NOT A HARD SHELL RESERVOIR ALL-IN-ONE TYPE. A REVIEW OF THE DEVICE HISTORY RECORD AND PRODUCT RELEASE DECISION CONTROL SHEET OF THE INVOLVED PRODUCT/LOT# COMBINATION CONFIRMED THAT THERE WERE NO PRODUCTION RELATED PROBLEMS OR NO DISCREPANCY IN THE INSPECTION/TEST RESULTS. A REVIEW OF THE COMPLAINT FILES CONFIRMED THAT THE INVOLVED PRODUCT/LOT# COMBINATION HAS NOT BEEN REPORTED PREVIOUSLY. DUE TO THE LIMITED INFORMATION, THE CAUSE OF THIS COMPLAINT CANNOT BE DETERMINED, THE ACTUAL SAMPLE WAS FOUND TO BE A HARD SHELL RESERVOIR, NOT AN INTEGRATED TYPE. ALL AVAILABLE INFORMATION HAS BEEN PLACED ON FILE IN QUALITY MANAGEMENT FOR APPROPRIATE TRACKING, TRENDING AND FOLLOW UP.

    Additional Manufacturer Narrative · 1

    THE EVALUATION IS YET TO BE COMPLETED. A FOLLOW UP WILL BE SENT WITHIN 30 DAYS OF THIS REPORT BEING SENT. ALL AVAILABLE INFORMATION HAS BEEN PLACED ON FILE IN QUALITY ASSURANCE FOR APPROPRIATE TRACKING, TRENDING AND FOLLOW-UP. CURRENTLY UNDER EVALUATION.

    Additional Manufacturer Narrative · 1

    (B)(4). THE ACTUAL DEVICE HAS NOT BEEN RECEIVED BY THE MANUFACTURING FACILITY FOR EVALUATION. A FOLLOW UP REPORT WILL BE SUBMITTED WITHIN 30 DAYS OF THE MANUFACTURER RECEIVING THE ACTUAL SAMPLE AND/OR NEW INFORMATION. A REVIEW OF DEVICE HISTORY RECORD AND THE PRODUCT RELEASE DECISION CONTROL SHEET OF THE INVOLVED PRODUCT/LOT NUMBER COMBINATION CONFIRMED THAT THERE WERE NO PRODUCT RELATED PROBLEMS AND NO DISCREPANCY IN THE INSPECTION/TEST RESULTS. A REVIEW OF THE COMPLAINT FILES CONFIRMED THAT THIS PRODUCT/LOT# COMBINATION HAS NOT BEEN REPORTED PREVIOUSLY. ALL AVAILABLE INFORMATION HAS BEEN PLACED ON FILE IN QUALITY ASSURANCE FOR APPROPRIATE TRACKING, TRENDING AND FOLLOW-UP. (B)(4). DEVICE NOT RETURNED TO MANUFACTURER.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THE APPEARANCE OF THE CAPIOX FX15 DEVICE DID NOT LOOK RIGHT. FOLLOW UP COMMUNICATION WITH THE USER FACILITY REPORTED THE FOLLOWING INFORMATION: IT WAS REPORTED WHEN TAKEN OUT OF THE BOX THE DEVICE DID NOT LOOK RIGHT; AND NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 1

    THIS REPORT IS BEING SUBMITTED AS FOLLOW-UP #2 FOR MFG. REPORT # 9681834-2015-00118 TO PROVIDE THE RETURN SAMPLE EVALUATION RESULTS AND TO PROVIDE THE CORRECT LOT NUMBER AND THE DEVICE MANUFACTURING DATE.

    Description of Event or Problem · 1

    THIS REPORT IS BEING SUBMITTED AS FOLLOW-UP #1 FOR MFR. REPORT # 9681834-2015-00118 TO PROVIDE THE EVALUATION UPDATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    397089 CAPIOX FX 15 HOLLOW FIBER OXYGENATOR AF OXYGENATOR DTZ TERUMO CORPORATION, ASHITAKA NA 141017

    Patients

    Seq Age Sex Outcome Treatment
    1