BEUDAMED
    FDA Adverse Event Death Summary report: N

    SAPPHIRE INFUSION PUMP

    MDR report key: 5006462 · Received August 16, 2015

    Report

    Report Number
    3010293992-2015-00155
    Event Type
    Death
    Date Received
    August 16, 2015
    Date of Event
    August 5, 2015
    Report Date
    August 6, 2015
    Manufacturer
    Q CORE MEDICAL LTD.
    Product Code
    FRN
    PMA / PMN Number
    K123049
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). Q CORE MEDICAL LTD (MANUFACTURER) IS REPORTING ON BEHALF OF HOSPIRA.

    Description of Event or Problem · 1

    THE EVENT WAS REPORTED BY A CUSTOMER FROM (B)(6): PUMP # 10 WAS INSTALLED YESTERDAY AT (B)(6) AND IT ALARMED OCCLUSION WITH A BUTTERFLY 25 1/2 IN (WHAT WE USE WITH HYPODERMOCLYSIS). NURSE (B)(6) SHOULD HAVE PUT A 23 CALIBRE FOR THIS FUNCTION (ITS A LARGE CALIBRATION FOR HYPODERMOCLYSIS) AFTER THE DEATH THIS MORNING DR (B)(6) WAS NOT ABLE TO TURN OFF THE PUMP, IT WOULD TURN ON BY ITSELF ALL THE TIME. THEY HAD TO REMOVE THE BATTERY TO HAVE IT FINALLY TURNED OFF. DELAY IN THERAPY: YES. NEED FOR MEDICAL INTERVENTION: YES. SERIOUS INJURY OR DEATH: YES. DETAILS: UNK(STATED DEATH, BUT NO INFO IF IT IS RELATED TO THE PUMP ISSUE). HUMAN HARM: YES. DETAILS: NURSE (B)(6) SHOULD HAVE PUT A 23 CALIBRE FOR THIS FUNCTION (ITS A LARGE CALIBRATION FOR HYPODERMOCLYSIS) AFTER THE DEATH THIS MORNING. ADDITIONAL INFORMATION: "IT IS MY UNDERSTANDING THAT THE DEATH IS NOT RELATED TO THE PUMP."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    541112 SAPPHIRE INFUSION PUMP FRN Q CORE MEDICAL LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1 Death