BEUDAMED
    FDA Adverse Event Death Summary report: N

    SAPPHIRE M.T INFUSION PUMP- US

    MDR report key: 6092060 · Received November 10, 2016

    Report

    Report Number
    3010293992-2016-00232
    Event Type
    Death
    Date Received
    November 10, 2016
    Date of Event
    October 7, 2016
    Report Date
    March 20, 2017
    Manufacturer
    Q CORE MEDICAL LTD.
    Product Code
    FRN
    UDI-DI
    07290109150109
    PMA / PMN Number
    K123049
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    THE EVENT WAS REPORTED BY A CUSTOMER FROM USA: "THIS IS IN REGARDS TO A PCA PUMP THAT WAS INVOLVED IN AN EVENT THAT MAY HAVE CAUSED DEATH OF A PATIENT. THE QUESTIONABLE DATES ARE ON (B)(6). HOWEVER, WE ARE NOT SURE IF IT WAS USER RELATED (I.E. SOMEONE IS CHANGING SETTINGS ON THE PUMP) OR THE PUMP FAILED TO DELIVER ACCURATELY AND WAS ALARMING. ONE OF OUR CONCERNS IS HOW A VI RESET WAS DONE ON (B)(6) 2016 AT 1:10. WE DIDNT THINK THIS IS POSSIBLE TO RESET IN THE PROGRAM. THE PATIENT HAS HAD THIS PUMP FOR QUITE SOME TIME, SINCE (B)(6), AND THEN THEY FINALLY WENT HOME AROUND (B)(6) 2016 WITH THIS SAME PUMP. POSSIBLE OVER DELIVERY. WHEN NURSE ARRIVED IN HOME AROUND 10:30PM ON (B)(6) 2016, PUMP WAS OFF AND FAMILY DIDN'T ANSWER FOR HOW LONG. PATIENT WAS NONRESPONSIVE AND MEDICATION BAG WAS DRY. NEW BAG AND NEW PUMP WERE SENT OUT THAT EVENING TO HOOK UP. PATIENT PASSED THE NEXT MORNING AT 8:30 AM (B)(6) 2016. TREATMENT SETTINGS: RATE: 5 MG PER HOUR CONTINUOUSLY WITH 2 MG BOLUS EVERY 15 MINS; VTBI: 500 ML; TIME: 24 HOURS, CONTINUOUSLY; MODE: PCA; ADMINISTRATION SET USED: SAPPHIRE TUBING 0.2 MICRON FILTER; WHAT CATHETER WAS USED:CENTRAL LINE R UPPER CHEST PORT; WHAT DRUG WAS ADMINISTERED DURING THE EVENT: DILAUDID; WHAT VOLUME WAS USED FOR PRIME: 0 ML. TUBING ATTACHED TO BAG IS PRIMED ALREADY; WHAT WAS THE INITIAL BAG VOLUME: 500 ML. RN WAS CALLED TO THE HOME BECAUSE PREVIOUS BAG WAS ALMOST OUT. PUMP SAID IT HAD 92 ML LEFT TO INFUSE BUT THERE WAS NOT THAT MUCH IN THE BAG. PER HOSPICE RECORD A NURSE ARRIVED AT THE HOME ON SATURDAY (B)(6) 2016 AT 12:45 PM FOR A BAG CHANGE. EACH BAG IS 500 ML AND ON (B)(6) 2016 AT 1:10 PER EVENT LOG VI WAS RESET TO 408 ML. IS THE VTBI DIFFERENT: PUMP WAS OFF WHEN NURSE ARRIVED VI SAID 181.3 ML AND VTBI WAS 410.7ML. DEVIATION BETWEEN THE PROGRAMED VTBI AND THE ACTUAL VOLUME LEFT: 0 ML. NO ALARMS HAD OCCURRED PER EVENT LOG OR RN. VOLUME LEFT IN THE BAG? 0 ML, BAG WAS COMPLETELY DRY AND PUMP WAS OFF. HUMAN HARM: YES; DELAY IN THERAPY: YES; NEED FOR MEDICAL INTERVENTION: YES."

    Description of Event or Problem · 0

    THE EVENT WAS REPORTED BY A CUSTOMER FROM USA: "POSSIBLE OVER DELIVERY. HUMAN HARM: YES. DELAY IN THERAPY: YES. NEED FOR MEDICAL INTERVENTION: YES".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    745765 SAPPHIRE M.T INFUSION PUMP- US INFUSION PUMP- FRN Q CORE MEDICAL LTD. 07290109150109

    Patients

    Seq Age Sex Outcome Treatment
    1 Death