BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SAPPHIRE M.T INFUSION PUMP- US

    MDR report key: 6065904 · Received October 30, 2016

    Report

    Report Number
    3010293992-2016-00241
    Event Type
    Malfunction
    Date Received
    October 30, 2016
    Date of Event
    September 9, 2016
    Report Date
    October 5, 2016
    Manufacturer
    Q CORE MEDICAL LTD.
    Product Code
    FRN
    UDI-DI
    07290109150109
    PMA / PMN Number
    K123049
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). EXEMPTION NUMBER, E2014005.

    Additional Manufacturer Narrative · 0

    (B)(4). EXEMPTION NUMBER, E2014005.

    Description of Event or Problem · 0

    THE EVENT WAS REPORTED BY A CUSTOMER FROM USA: OVER DELIVERY.

    Description of Event or Problem · 0

    THE EVENT WAS REPORTED BY A CUSTOMER FROM USA: "SAPPHIRE PUMP OVER INFUSION - HOSPIRA PCA SHOWING 47CC OF DRUG LEFT WHEN IN ACTUALITY THE BAG WAS EMPTY. RAN FOR APPR 48 HOURS ON SAME PROGRAM USING SAVED BAG AND TUBING VI100ML, ACTUAL DELIVERY 113.5. PUMP TREATMENT INFORMATION:CONC 10:1MG/ML, RATE 50MCG/HR, BOLUS 25MCG, 10 MIN LOCKOUT, 6 BOLUSES/HR. ALARM SETTINGS: OCCLUSION UNITS PSI, OCCLUSION PRESSURE 10PSI, PUMP UNATTENDED 2 MIN, INFUSION NEAR END 10 MIN, ALARM VOLUME MAX. TYPE OF DRUG: FENTANYL. KINDLY ACKNOWLEDGE NO HUMAN HARM CAUSED: CAUSED NO HUMAN HARM. WHAT WAS THE PRESSURE (OCCLUSION) SENSOR SETTING (0.4-1.2 BAR): 10PSI. WHAT WAS THE INITIAL BAG VOLUME: 100ML. WHAT WAS THE VOLUME LEFT IN THE BAG: PUMP SHOWS 47CC, ACTUAL BAG IS EMPTY. PATIENT INVOLVEMENT: YES. DEATH/SERIOUS INJURY: NO. HUMAN HARM: NO. MEDICAL INTERVENTION NEEDED: NO."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    716795 SAPPHIRE M.T INFUSION PUMP- US INFUSION PUMP FRN Q CORE MEDICAL LTD. 07290109150109

    Patients

    Seq Age Sex Outcome Treatment
    1