BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SAPPHIRE INFUSION PUMP

    MDR report key: 6176332 · Received December 15, 2016

    Report

    Report Number
    3010293992-2016-00260
    Event Type
    Malfunction
    Date Received
    December 15, 2016
    Date of Event
    July 10, 2015
    Report Date
    November 16, 2016
    Manufacturer
    Q CORE MEDICAL LTD.
    Product Code
    FRN
    PMA / PMN Number
    K123049
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    HOSPIRA INC. US SERVICE CENTER (B)(4). Q CORE MEDICAL LTD (MANUFACTURER) IS SUBMITTING THE REPORT ON BEHALF OF HOSPIRA. EXEMPTION NUMBER, E2014005.

    Description of Event or Problem · 0

    THE EVENT WAS REPORTED BY A CUSTOMER FROM USA: "THE PATIENT WITNESSED CLINICIAN PUTTING LOCK CODE. PATIENT UNLOCKED THE PUMP AND CHANGED PCA CONTINUOUS RATE, GIVING MORE MEDICATION. THOUGH ASKED, WAS NOT ABLE TO PROVIDE THE TYPE OF MEDICATION USED, PRESCRIBED VOLUME AND TOTAL VOLUME INFUSED. CUSTOMER QUOTED THE CODES SHOULD NOT HAVE BEEN VISIBLE ON DISPLAY WHEN ENTERED. PATIENT INVOLVEMENT: YES. HUMAN HARM: NO".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    830606 SAPPHIRE INFUSION PUMP INFUSION PUMP FRN Q CORE MEDICAL LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown