BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SAPPHIRE M.T INFUSION PUMP

    MDR report key: 6126972 · Received November 24, 2016

    Report

    Report Number
    3010293992-2016-00266
    Event Type
    Malfunction
    Date Received
    November 24, 2016
    Report Date
    November 24, 2016
    Manufacturer
    Q CORE MEDICAL LTD.
    Product Code
    FRN
    UDI-DI
    07290109150109
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE EVENT WAS REPORTED BY A CUSTOMER FROM (B)(6): "UNCONTROLLED BOLUSES INFUSION - (B)(6) CAME TO THE KNOWLEDGE OF THREE FEEDBACKS AS REGARDS SAPPHIRE MT PUMPS USED IN PCA MODE, IN AMBULATORY FOR MORPHINE INFUSIONS. THE PUMPS ARE IN BAGS OR IN WALLETS. UNCONTROLLED BOLUSES INFUSION. THE TOUCH PANEL KEYS "BOLUS" AND "OK"(THE CONFIRMATION) ON THE SCREEN WERE PRESSED IN THE BAG FOR ONE "SHOT", BUT NOT BY THE PATIENT INTENTIONALLY. UNWANTED BOLUSES WERE DELIVERED (NO BOLUS DELIVERED DURING THE REFRACTORY PERIOD). VERY HIGH DISSATISFACTION OF THE CLIENT, WHO HEAVILY REQUIRES AN ENDURING SOLUTION IN ORDER TO BE ABLE TO USE SAPPHIRE DEVICES IN COMPLETE SAFETY IN BAGS OR WALLETS. INCREASED RISK OF THE PATIENTS: THE BOLUS ADMINISTRATION WAS IMPOSSIBLE BECAUSE OF THE REFRACTORY PERIOD, EVEN THOUGH THE NECESSITY WAS REAL. RISKS: INCREASING RISKS OF DEPENDENCE. CONCERNING THE POTENTIAL EFFECTS OF MORPHINE: LOSS OF ALERTNESS, MAY LEAD TO ACCIDENTS IF THE PATIENT IS PERFORMING AN ACTIVITY WHICH REQUIRES CONCENTRATION, SUCH AS DRIVING A CAR INCREASED RISK. TYPE OF DRUG: MORPHINE, PATIENT INVOLVEMENT: YES". ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER: "KINDLY ACKNOWLEDGE WHAT HUMAN HARM CAUSED AND WHAT IS THE CONDITION OF THE PATIENT? THE BOLUS WAS ADMINISTERED EARLIER THAN IT SHOULD HAVE BEEN, AND THE PATIENT COULD NOT RECEIVE THE BOLUS WHEN DESIRED. THE PATIENT IS DOING WELL. IF POSSIBLE, PLEASE PROVIDE THE AMOUNT OF UNINTENDED BOLUS THAT DELIVERED TO THE PATIENT? ONCE. PLEASE CLARIFY IF Q CORE BAGS WERE USED OR OTHER BAGS AND WALLETS? Q CORE BAGS WERE USED. WAS THE SCREEN ON LOCKED STATE WHEN THE PUMP WAS IN THE BAG? YES. ADMINISTRATION SET USED (TYPE AND LOT NUMBER): AP424".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    777885 SAPPHIRE M.T INFUSION PUMP INFUSION PUMP FRN Q CORE MEDICAL LTD. 07290109150109

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown