BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SAPPHIRE M.T INFUSION PUMP - SPANISH

    MDR report key: 6137671 · Received December 1, 2016

    Report

    Report Number
    3010293992-2016-00274
    Event Type
    Malfunction
    Date Received
    December 1, 2016
    Date of Event
    November 24, 2016
    Report Date
    February 19, 2020
    Manufacturer
    Q CORE MEDICAL LTD.
    Product Code
    FRN
    UDI-DI
    07290109150109
    PMA / PMN Number
    K123049
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    B.6 TIME LINES: LATE SUBMISSION- DISCUSSED WITH THE FDA OVER A PHONE CALL ON THE(B)(6)2020 . G.1 DISTRIBUTOR INFORMATION: HOSPIRA INC. US SERVICE CENTER (B)(4). EXEMPTION NUMBER, E2014005 Q CORE MEDICAL LTD (MANUFACTURER) IS SUBMITTING THE REPORT ON BEHALF OF HOSPIRA.

    Additional Manufacturer Narrative · 0

    (B)(6). (B)(4). EXEMPTION NUMBER, E2014005.

    Description of Event or Problem · 0

    THE EVENT WAS REPORTED BY A CUSTOMER FROM COLOMBIA: PROGRAMING ISSUE.

    Description of Event or Problem · 0

    THE EVENT WAS REPORTED BY A CUSTOMER FROM (B)(6): "THE PUMP WAS SELF-PROGRAMMED. THE REPORTER STATED THAT THE PUMP WAS PROGRAMMED TO 10 BOLUS IN 4HOURS 1MG/BOLUS, WHEN REVISED THE PUMP NOTICED THAT IT SELF PROGRAMMED TO BOLUS IN 1 HOUR, PROGRAMMED IT AGAIN TO 10 BOLUS IN 4 HOURS BUT THEN WHEN REVISING THE PUMP AGAIN, IT HAD SELF PROGRAMMED AGAIN TO 10 BOLUS IN 1 HOUR. THEREFORE, THE PUMP WAS CHANGED AND SENT TO HOSPITAL BIOMEDICAL DEPARTMENT WHERE IT WILL BE REVISED TODAY BY HOSPIRA BIOMEDICAL ENGINEER (B)(6). THERE WAS PATIENT INVOLVED, BUT WAS NOT HARMED. PATIENT INFORMATION IS NOT AVAILABLE. THERE WAS NO ADVERSE EVENT, NEITHER DELAY IN THERAPY. THE PUMP REFERENCE NUMBER AND SOFTWARE VERSION WILL BE SENT BY EMAIL. NO OTHER INFORMATION IS PROVIDED. PUMP TREATMENT INFORMATION:10 BOLUS IN 4 HOUR 1 MG/BOLUS. TYPE OF DRUG: MORPHINE. WAS THERE A PRIME PERFORMED: YES. PUMP OR MANUAL: PUMP. PATIENT INVOLVEMENT: YES. DEATH/SERIOUS INJURY: NO. HUMAN HARM: NO. DELAY IN THERAPY: NO. MEDICAL INTERVENTION NEEDED: NO".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    788621 SAPPHIRE M.T INFUSION PUMP - SPANISH INFUSION PUMO FRN Q CORE MEDICAL LTD. 07290109150109

    Patients

    Seq Age Sex Outcome Treatment
    1