BEUDAMED
    FDA Adverse Event Death Summary report: N

    MEDFUSION 2001 SYRINGE INFUSION PUMP

    MDR report key: 1701109 · Received May 24, 2010

    Report

    Report Number
    2183502-2010-00201
    Event Type
    Death
    Date Received
    May 24, 2010
    Manufacturer
    SMITHS MEDICAL MD
    Product Code
    FRN
    PMA / PMN Number
    K890120
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INITIAL REPORTER WAS CONTACTED FOR ADD'L INFO AND TO ARRANGE RETURN OF THE DEVICE FOR EVAL. THE USER FACILITY REPORTED THE PT HAD MULTIPLE CO-MORBIDITIES AND WAS CRITICALLY ILL PRIOR TO THE EVENT. THE DEVICE IS CURRENTLY QUARANTINED AND THE FACILITY IS CONDUCTING AN INVESTIGATION. THE USER FACILITY IS NOT WILLING TO HAVE THE DEVICE RETURNED FOR INVESTIGATION OR TO HAVE A REP OF THE MFR BE PRESENT DURING AN INTERNAL INVESTIGATION. THE USER FACILITY USED A 10 ML SYRINGE FOR THE INFUSION, THE INITIAL REPORTER IS UNSURE OF THE INFUSION PROTOCOL OR THE BRAND OF THE SYRINGE. THE INITIAL REPORTER DID CLARIFY THAT THE DEVICE WAS RETURNED TO "(B) (4)" IN 2009 FOR A PLUNGER ISSUE NOT "NOT MFR" AS STATED IN THE (B) (4). THE MFR DID EXPLAIN THAT THEY ARE NOT AFFILIATED WITH "(B) (4)" AND THE INITIAL REPORTER VERBALIZED UNDERSTANDING. THE INITIAL REPORTER WILL CONTACT THE MFR IF THE FACILITY WILL BE CONDUCTING ANY FURTHER INVESTIGATION INTO THE DEVICE. (B) (4)

    Description of Event or Problem · 1

    .

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDFUSION 2001 SYRINGE INFUSION PUMP SYRINGE INFUSION PUMP FRN SMITHS MEDICAL MD 2001 NA

    Patients

    Seq Age Sex Outcome Treatment
    1