BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIFECARE PCA 3

    MDR report key: 1161191 · Received September 15, 2008

    Report

    Report Number
    2921482-2008-00295
    Event Type
    Injury
    Date Received
    September 15, 2008
    Date of Event
    August 20, 2008
    Report Date
    August 25, 2008
    Manufacturer
    HOSPIRA, INC.
    Product Code
    MEA
    PMA / PMN Number
    K022203
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    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.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED AN ADVERSE EVENT WHILE THE PUMP WAS IN USE. ON AN UNSPECIFIED DATE AND TIME, THE PUMP WAS PROGRAMMED TO DELIVER KETAMINE 10MG/DL IN THE CONTINUOUS ONLY MODE AT A RATE OF 19MG/HR, NO DOSE LIMIT WAS SELECTED AND THE DELIVERY WAS STARTED. THE CUSTOMER CONTACT REPORTED THE PATIENT WAS ALSO RECEIVING AN UNSPECIFIED CONCENTRATION OF MORPHINE VIA ANOTHER PCA 3 PUMP. NO SPECIFIC PROGRAMMING PARAMETERS WERE PROVIDED. AFTER APPROXIMATELY 30 MINUTES, THE PATIENT BECAME "UNRESPONSIVE." THE DELIVERY WAS STOPPED. THE PHYSICIAN & THE RAPID RESPONSE TEAM WERE NOTIFIED. THE PATIENT WAS TREATED WITH 100% OXYGEN BY REBREATHER MASK. AFTER AN UNSPECIFIED LENGTH OF TIME, THE PATIENT WAS RESPONSIVE AND FULLY ALERT. THE THERAPIES WERE DISCONTINUED. THE PATIENT WAS TRANSFERRED TO THE INTERMEDIATE CARE UNIT FOR OBSERVATION. THE PUMP WAS REMOVED FROM CLINICAL SERVICE. THERE WERE NO REPORTED ADVERSE PATIENT SEQUELAE. THE CUSTOMER CONTACT REPORTED THAT "THE ACUTE PAIN SERVICE DID NOT THINK THE PUMP WAS AT FAULT. THEY THOUGHT THE INCIDENT WAS DUE TO A CUMULATIVE EFFECT OF THE DRUG AFTER A BOLUS." THOUGH REQUESTED NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Life Threatening| R LIFECARE PCA 3 PUMP| KETAMINE MANUFACTURED BY HOSPIRA INC.| MORPHINE