BEUDAMED
    FDA Adverse Event Injury Summary report: N

    Q CORE SAPPHIRE PUMP

    MDR report key: 4345943 · Received August 11, 2014

    Report

    Report Number
    3010293992-2014-00004
    Event Type
    Injury
    Date Received
    August 11, 2014
    Date of Event
    July 4, 2014
    Report Date
    July 10, 2014
    Manufacturer
    Q CORE MEDICAL LTD
    Product Code
    FRN
    PMA / PMN Number
    K123049
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DISTRIBUTOR INFO: (B)(4). Q CORE MEDICAL LTD (MANUFACTURER) IS SUBMITTING THE REPORT ON BEHALF OF (B)(4).

    Description of Event or Problem · 1

    PROBLEM AS DESCRIBED IN THE COMPLAINT: THE PT FELL INTO A COMA AT HOME 5 MINUTES AFTER A MORPHINE BOLUS WAS GIVEN. THE PT WAS HOSPITALIZED. NO DATA AVAILABLE ON THE DESCRIPTION OF THE INFUSION PROCESS. TREATMENT: MORPHINE. INFUSION SET: (B)(4). PT CONSEQUENCES: COMA, THE PT HAS RECOVERED. ADD'L INFO RECEIVED ON (B)(6) 2014 FROM THE CUSTOMER (USER) ANSWERING SPECIFIC QUESTIONS FROM Q CORE: MEDICAL PRESCRIPTION ON (B)(6) 2014; THE PUMP HAS BEEN INSTALLED ON (B)(6) 2014 (EVENING); NURSE'S VISIT ON (B)(6) 2014 (MORNING); 1ST BOLUS ASKED ON (B)(6) 2014 (MORNING); ISSUE OCCURRED FEW MINUTES AFTER THE BOLUS PRESCRIPTION 0.5MG/H (THAT IS TO SAY 12MG/24H); BOLUS 2MG/H (MAX 1 BOLUS/H).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    475368 Q CORE SAPPHIRE PUMP INFUSION PUMP FRN Q CORE MEDICAL LTD SAPPHIRE M.T NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention