BEUDAMED
    FDA Adverse Event Other Summary report: N

    PLUM A+3 V11.51 NEW

    MDR report key: 1654370 · Received April 7, 2010

    Report

    Report Number
    2921482-2010-00199
    Event Type
    Other
    Date Received
    April 7, 2010
    Date of Event
    March 8, 2010
    Report Date
    March 10, 2010
    Manufacturer
    HOSPIRA, INC.
    Product Code
    FRN
    PMA / PMN Number
    K024084
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT ISOLATED OR IDENTIFIED BY SERIAL NUMBER; THEREFORE, IT WILL NOT BE RETURNED FOR INVESTIGATION. THE CUSTOMER CONTACT INDICATED THE EVENT WAS THE RESULT OF AN OPERATOR ERROR IN PROGRAMMING THE DEVICE. THIS REPORT REPRESENTS ALL THE INFO KNOWN BY THE REPORTER UPON QUERY BY HOSPIRA PERSONNEL. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED AN OPERATOR ERROR IN PROGRAMMING THE DEVICE, WHICH RESULTED IN THE PATIENT RECEIVING MORE MEDICATION THAN INTENDED. THE PATIENT WAS ADMITTED WITH A DIAGNOSIS OF CONGESTIVE HEART FAILURE. AFTER AN UNSPECIFIED LENGTH OF TIME, THE PATIENT'S CONDITION REPORTEDLY DETERIORATED AND THE PATIENT "PRE-CODED." THE PATIENT WAS TRANSFERRED TO THE ICU (INTENSIVE CARE UNIT). THE PATIENT REQUIRED AN ADVANCED AIRWAY AND PROPOFOL WAS ORDERED FOR SEDATION. THE DEVICE WAS PROGRAMMED TO DELIVER AN UNSPECIFIED CONCENTRATION OF PROPOFOL AT A RATE OF 5ML/HR. NO FURTHER PROGRAMMING PARAMETERS WERE PROVIDED. AFTER AN UNSPECIFIED LENGTH OF TIME, THE PATIENT WENT INTO CARDIAC ARREST. AFTER AN UNSPECIFIED LENGTH OF TIME, THE PHYSICIAN ORDERED AN UNSPECIFIED IV LINE FLUSHED. REPORTEDLY, THE NURSE PROGRAMMED THE DEVICE TO DELIVER THE PROPOFOL AT A RATE OF 999ML/HR. AFTER APPROXIMATELY 2ML WAS DELIVERED, THE PHYSICIAN ORDERED THE DELIVERY RATE TO BE DECREASED TO AN UNSPECIFIED RATE. THE NURSE REPROGRAMMED THE DEVICE TO DELIVER THE NEW RATE. THE CUSTOMER CONTACT STATED THE NURSE DID NOT RESPOND TO THE CONFIRMATION SCREEN TO ACCEPT THE NEW PROGRAMMING. THE DEVICE CONTINUED TO DELIVER THE PROPOFOL AT THE PREVIOUSLY PROGRAMMED RATE OF 999ML/HR. FOR AN UNSPECIFIED LENGTH OF TIME. AT AN UNSPECIFIED TIME, THE PATIENT EXPIRED. THE CAUSE OF DEATH HAS NOT YET BEEN DETERMINED. ALTHOUGH REQUESTED, NO ADDITIONAL INFO WAS AVAILABLE AT THIS TIME. HOSPIRA IS CONTINUING TO INVESTIGATE THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PLUM A+3 V11.51 NEW 80FRN FRN HOSPIRA, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Death PROPOFOL, MANUFACTURER UNK