BEUDAMED
    FDA Adverse Event Death Summary report: N

    PLUM A+ 11.6 BRAZIL

    MDR report key: 1677987 · Received May 6, 2010

    Report

    Report Number
    2921482-2010-00309
    Event Type
    Death
    Date Received
    May 6, 2010
    Date of Event
    April 1, 2010
    Report Date
    April 6, 2010
    Manufacturer
    HOSPIRA, INC.
    Product Code
    FRN
    PMA / PMN Number
    K070398
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS EXPECTED TO BE RETURNED FOR INVESTIGATION. IT HAS YET BEEN RECEIVED. (B) (4). (B) (4).

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED THE PUMP DID NOT DELIVER. AT 1830, THE PUMP WAS PROGRAMMED TO DELIVER AN UNSPECIFIED CONCENTRATION OF DOBUTAMINE AT A RATE OF 30ML/HR. NO FURTHER PROGRAMMING PARAMETERS WERE PROVIDED. AT 1940, THE PHYSICIAN NOTED THE PUMP WAS STILL POWERED ON; HOWEVER, THE DELIVERY HAD STOPPED DELIVERING. NO AUDIBLE ALARM TONE WAS REPORTED. AT 2200, IT WAS REPORTED THE PT HAD BRADYCARDIA. NO SPECIFIC VALUE WAS PROVIDED. AT 2230, THE PT WENT INTO CARDIOGENIC SHOCK. RESUSCITATION PROCEDURES WERE PERFORMED. THE PT WAS TREATED WITH UNSPECIFIED CONCENTRATIONS OF XYLOCAINE 3ML, CALCIUM GLUCONATE 2 VIALS, MAGNESIUM SULFATE 2 VIALS, SODIUM BICARBONATE 2MG, AND "ANCORON." IT WAS REPORTED THAT CARDIOVERSION AT 150 JOULES WAS PERFORMED TWICE. THE PT EXPIRED AT 2300. THE DEVICE WAS REMOVED FROM CLINICAL SERVICE. INFO WAS REQUESTED FROM THE CUSTOMER CONTACT REGARDING SPECIFIC EVENT DETAILS THAT OCCURRED DURING THE 1940 TO 2200 TIMEFRAME. NO RESPONSE WAS RECEIVED. HOSPIRA IS CONTINUING TO INVESTIGATE THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PLUM A+ 11.6 BRAZIL 80FRN FRN HOSPIRA, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Death PLUM A+ SOFTWARE MODULE, LIST #12097,(B) (4)| DOBUTAMINE, MANUFACTURER UNK