BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SAPPHIRE M.T INFUSION PUMP

    MDR report key: 5226699 · Received November 16, 2015

    Report

    Report Number
    3010293992-2015-00205
    Event Type
    Malfunction
    Date Received
    November 16, 2015
    Date of Event
    October 13, 2015
    Report Date
    October 20, 2015
    Manufacturer
    Q CORE MEDICAL LTD.
    Product Code
    FRN
    PMA / PMN Number
    K123049
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE EVENT WAS REPORTED BY A CUSTOMER FROM USA: "DEVICE IS UNDER INFUSING. FAILS ACCURACY DURING BIOMED TESTING. DELAY IN THERAPY: NO. NEED FOR MEDICAL INTERVENTION: NO. DEATH / SERIOUS INJURY: NO." ADDITIONAL INFORMATION WAS RECEIVED ON OCT. 22ND, 2015: KINDLY ACKNOWLEDGE NO PATIENT WAS INVOLVED AND NO HUMAN HARM CAUSED. NONE. WHAT SOFTWARE VERSION IS INSTALLED ON THE DEVICE? R11V52. WHAT WERE THE TREATMENT SETTINGS? N/A. RATE: 125ML/HR. VTBI: 20ML. TIME: N/A. MODE: CONTINUES. WHAT WAS THE PRESSURE (OCCLUSION) SENSOR SETTING (0.4-1.2 BAR)? .8 BAR. ADMINISTRATION SET USED (TYPE AND LOT NUMBER): 12003-000-0020. WHAT CATHETER WAS USED (SIZE OF CATHETER, TYPE, CATALOG NUMBER, MANUFACTURER, ETC.?) NONE. DRUG ADMINISTERED: N/A. PRIMING METHOD (MANUAL / WITH PUMP): MANUAL. WHAT VOLUME WAS USED FOR PRIME? N/A. WHAT WAS THE BAG VOLUME: N/A. PLEASE DESCRIBE WHAT IS THE DEVIATION FROM THE DESCRIBED TREATMENT YOU HAVE OBSERVED. GRAVIMETRIC RESULTS TEST ONE: 18.8ML / TEST TWO:18.76ML / TEST THREE: 18.11ML . DID YOU EXPERIENCE ANY ALARMS AT THE BEGINNING / DURING / AT THE END OF THE TREATMENT, IF SO, PLEASE DETAIL THE ALARMS AND THEIR OCCURRENCES. NONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    755489 SAPPHIRE M.T INFUSION PUMP SAPPHIRE M.T INFUSION PUMP FRN Q CORE MEDICAL LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1