BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SAPPHIRE M.T INFUSION PUMP- US

    MDR report key: 6108776 · Received November 17, 2016

    Report

    Report Number
    3010293992-2016-00250
    Event Type
    Malfunction
    Date Received
    November 17, 2016
    Date of Event
    October 20, 2016
    Report Date
    March 30, 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
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

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

    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,(B)(4). Q CORE MEDICAL LTD (MANUFACTURER) IS SUBMITTING THE REPORT ON BEHALF OF HOSPIRA. EXEMPTION NUMBER, E2014005.

    Description of Event or Problem · 0

    THE EVENT WAS REPORTED BY A CUSTOMER FROM USA: "OVER DELIVERY - A PATIENT LAST NIGHT RECEIVED OVER DELIVERY FROM A SAPPHIRE MT PUMP. THAT PATIENT WAS UNRESPONSIVE. THE RAPID RESPONSE TEAM GAVE NARCAN. THE BAG OF THE PCA IS EMPTY WHICH HAS A DILAUDID 20MG IN 100ML, IT SUPPOSED TO HAVE A LOT OF FLUID THERE. GAVE THE NARCAN AND THEY RESUSCITATE THE PATIENT. THE PATIENT NOW IS OKAY. DRUG DELIVERED: DILAUDID PATIENT INVOLVEMENT: YES. HUMAN HARM: YES. MEDICAL INTERVENTION NEEDED: YES."

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    762502 SAPPHIRE M.T INFUSION PUMP- US INFUSION PUMP FRN Q CORE MEDICAL LTD. 07290109150109

    Patients

    Seq Age Sex Outcome Treatment
    1