BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SAPPHIRE MULTI THERAPY INFUSION PUMP

    MDR report key: 4802195 · Received May 27, 2015

    Report

    Report Number
    3010293992-2015-00082
    Event Type
    Injury
    Date Received
    May 27, 2015
    Date of Event
    May 18, 2014
    Report Date
    May 21, 2015
    Manufacturer
    Q CORE MEDICAL LTD
    Product Code
    FRN
    PMA / PMN Number
    K123049
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) (MANUFACTURER) IS SUBMITTING THE REPORT ON BEHALF OF HOSPIRA. IMP. REF. #(B)(4).

    Description of Event or Problem · 1

    THE EVENT REPORTED BY A CUSTOMER FROM USA: "PATIENT HAD A 46 HOUR CHEM INFUSION THT WAS ADMINISTERED IN ABOUT 90 MINS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    342399 SAPPHIRE MULTI THERAPY INFUSION PUMP INFUSION PUMP FRN Q CORE MEDICAL LTD INFUSION PUMP NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK