BEUDAMED
    FDA Adverse Event Death Summary report: N

    3C PCA NEW 802.11 AB

    MDR report key: 1663365 · Received April 19, 2010

    Report

    Report Number
    2921482-2010-00258
    Event Type
    Death
    Date Received
    April 19, 2010
    Date of Event
    March 25, 2010
    Report Date
    March 25, 2010
    Manufacturer
    HOSPIRA, INC.
    Product Code
    MEA
    PMA / PMN Number
    K042800
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    AT THIS TIME THE CUSTOMER WILL NOT BE RETURNING THE DEVICE FOR EVALUATION. THE CUSTOMER CONTACT REPORTED THAT DURING TESTING AT THE USER FACILITY, THE PUMP PASSED TESTING. (B) (4)

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED A PT DEATH WHILE THE PUMP WAS IN USE. AT AN UNSPECIFIED TIME, THE PUMP WAS PROGRAMMED TO DELIVER MORPHINE 1MG/DL, IN THE PCA ONLY MODE, WITH A 2.0MG PCA DOSE, AND A 15 MINUTE PT LOCKOUT. NO FURTHER PROGRAMMING PARAMETERS WERE PROVIDED. THE PT WAS BEING TREATED POST OPERATIVELY IN THE CARDIAC INTENSIVE CARE UNIT AND WAS ON CONTINUOUS CARDIAC MONITORING. AT UNSPECIFIED TIME, THE NURSE ENTERED THE PT'S ROOM AND FOUND THE PT IN ASYSTOLE. AT 2053, A CODE WAS CALLED AND CPR WAS PERFORMED. THE PT WAS INTUBATED AND WAS TREATED WITH UNSPECIFIED CONCENTRATIONS OF EPINEPHRINE AND DOPAMINE. THE CUSTOMER REPORTED "THE CODE WAS UNABLE TO REVIVE HER." AT 2113, THE PT EXPIRED. THE CAUSE OF DEATH WAS NOT SPECIFIED. AN AUTOPSY WAS NOT PERFORMED. THE CUSTOMER REPORTED THAT THE PT HAD RECEIVED A TOTAL OF 4MG OF MORPHINE. THE PUMP WAS REMOVED FROM CLINICAL SERVICE. DURING TESTING AT THE USER FACILITY, IT WAS REPORTED THE PUMP PASSED TESTING AND "WAS WORKING PROPERLY WITH NO ISSUE." THE CUSTOMER CONTACT INDICATED THAT AFTER THE EVENT, IT WAS FOUND THE PT'S AUTOMATIC INTERNAL CARDIAC DEFIBRILLATOR (AICD) "WAS NOT WORKING CORRECTLY." NO SPECIFIC DETAILS WERE PROVIDED. THE CUSTOMER INDICATED THAT THE EVENT WAS NOT THE RESULT OF ANY MALFUNCTION OF THE PUMP. THOUGH REQUESTED, NO ADDITIONAL INFO WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 3C PCA NEW 802.11 AB 80MEA MEA HOSPIRA, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Death MORPHINE, MFR BY INTL MEDICATION SYSTEMS, LTD.