BEUDAMED
    FDA Adverse Event Death Summary report: N

    LIFECARE PCA 3 V5.06

    MDR report key: 1603514 · Received February 8, 2010

    Report

    Report Number
    2921482-2010-00053
    Event Type
    Death
    Date Received
    February 8, 2010
    Date of Event
    January 1, 2009
    Report Date
    January 12, 2010
    Manufacturer
    HOSPIRA, INC.
    Product Code
    MEA
    PMA / PMN Number
    K042800
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AT THIS TIME, THE CUSTOMER WILL NOT BE RETURNING THE DEVICES FOR EVALUATION. IF THE DEVICES ARE RECEIVED, A FOLLOW-UP REPORT WILL BE SUBMITTED. THE DEVICE WAS NOT IDENTIFIED BY SERIAL NUMBER, HOWEVER, THE CUSTOMER HAS IDENTIFIED FOUR POSSIBLE SERIAL NUMBERS: (B) (4). THE PUMP HISTORIES WERE DOWNLOAD AND PRINTED AT THE USER FACILITY. THE CUSTOMER DID NOT PROVIDE AN EVENT DATE OR PROGRAMMING PARAMETERS; THEREFORE, THE HISTORIES CANNOT BE UTILIZED TO EVALUATE THE REPORTED EVENT. (B) (4)

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED A DEATH WHILE THE DEVICE WAS IN USE. THE PUMP WAS BEING USED TO DELIVER AN UNSPECIFIED MEDICATION. AFTER AN UNSPECIFIED LENGTH OF TIME IN USE, IT WAS REPORTED THE PT EXPIRED. THE CUSTOMER CONTACT REPORTED "THERE WAS NO PUMP FAILURE." DURING TESTING AT THE USER FACILITY, THE PUMP "TESTED JUST FINE." INFO WAS REQUESTED FROM THE CUSTOMER CONTACT INCLUDING THE EVENT DATE, PT'S INFO, THE NAME OF THE MEDICATION BEING DELIVERED, PUMP PROGRAMMING PARAMETERS, SPECIFIC EVENT DETAILS, ACTIONS TAKEN AS A RESULT OF THE EVENT, THE DATE OF DEATH, AND THE PT'S DIAGNOSIS. THE CUSTOMER CONTACT HAS DECLINED TO PROVIDE ADDITIONAL INFO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFECARE PCA 3 V5.06 80MEA MEA HOSPIRA, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Death