BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERILE FX25RW OX W/ RES

    MDR report key: 4777975 · Received May 14, 2015

    Report

    Report Number
    1124841-2015-00162
    Event Type
    Malfunction
    Date Received
    May 14, 2015
    Date of Event
    April 28, 2015
    Report Date
    July 28, 2015
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP.
    Product Code
    DTZ
    PMA / PMN Number
    K140774
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    TERUMO HAS RECEIVED THE ACTUAL DEVICE FOR EVALUATION; HOWEVER, THE INVESTIGATION HAS YET TO BE COMPLETED. TERUMO PLANS ON SUBMITTING A FOLLOW-UP REPORT WHEN THE INVESTIGATION IS COMPLETE AND MORE INFORMATION BECOMES AVAILABLE. (B)(4).

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS SUBMITTED TO THE FDA IN ACCORD WITH APPLICABLE REGULATIONS AND AS INDICATED BY TERUMO CARDIOVASCULAR SYSTEMS ¿ AND AS INDICATED BY TERUMO CARDIOVASCULAR SYSTEMS IN THE INITIAL REPORT SUBMITTED TO THE FDA ON MAY 14, 2015. (B)(4). THE ACTUAL DEVICE WAS VISUALLY INSPECTED UPON RECEIPT, AND THE REPORTED DAMAGE TO THE FILTERED LUER PORT WAS CONFIRMED. THE THREADS ON THE LUER PORT APPEARED TO BE STRIPPED. FURTHER INSPECTION REVEALED THAT THE PURGE LINE HAD BEEN MOVED TO ANOTHER ONE OF THE FILTERED LUER PORTS. THE ANGLED MALE LUER ON THE OXYGENATOR PURGE LINE WAS INSPECTED BUT NO DAMAGE WAS OBSERVED. THIS INDICATES THAT THE DAMAGE WAS NOT CAUSED WHEN REMOVING THE PURGE LINE. SINCE THE DAMAGED CAP WAS NOT RETURNED, IT COULD NOT BE DETERMINED IF THE DAMAGE OCCURRED DURING MANUFACTURING OR DURING CUSTOMER USE. (B)(4). ALL AVAILABLE INFORMATION HAS BEEN PLACED ON FILE IN QUALITY MANAGEMENT FOR APPROPRIATE TRACKING, TRENDING AND FOLLOW UP.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR SYSTEMS CORP. THAT DURING SETUP, THE OXYGENATOR LUER PORT CAP WAS STUCK. TORQUE WAS USED TO REMOVE IT RESULTING IN THE CAP BREAKING AND A PIECE WENT INTO THE RESERVOIR. NO PT INVOLVEMENT AS THIS OCCURRED DURING SETUP. PRODUCT WAS CHANGED OUT. SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT DELAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    316544 STERILE FX25RW OX W/ RES BLOOD GAS OXYGENATOR DTZ TERUMO CARDIOVASCULAR SYSTEMS CORP. 3CX FX25RW TC09

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK