BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIFECARE PCA 3 V5.06

    MDR report key: 1833634 · Received September 8, 2010

    Report

    Report Number
    2921482-2010-00682
    Event Type
    Injury
    Date Received
    September 8, 2010
    Date of Event
    August 1, 2010
    Report Date
    August 13, 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
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS EXPECTED TO BE RETURNED FOR INVESTIGATION. IT HAS NOT YET BEEN RECEIVED. 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 ADVERSE EVENT WHILE THE DEVICE WAS IN USE. ON AN UNSPECIFIED DATE AND TIME, THE PUMP WAS PROGRAMMED TO DELIVER AN UNSPECIFIED MEDICATION. NO SPECIFIC PROGRAMMING PARAMETERS WERE PROVIDED. THE CUSTOMER CONTACT REPORTED THAT ON AN UNSPECIFIED DATE AND TIME, THE PT EXPERIENCED A RESPIRATORY ARREST. IT WAS REPORTED THAT "RAPID RESPONSE" WAS INITIATED. IT WAS REPORTED, THE PT WAS TREATED WITH AN UNSPECIFIED CONCENTRATION OF NARCAN. THE CUSTOMER CONTACT REPORTED, THE PT WAS "OK." THOUGH REQUESTED, THE CUSTOMER HAS DECLINED TO PROVIDE ADD'L INFO INCLUDING SPECIFIC PT INFO, PUMP PROGRAMMING, AND EVENT DETAILS.

    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 Required Intervention