BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIFECARE PCA 3 V5.06

    MDR report key: 1940401 · Received December 20, 2010

    Report

    Report Number
    2921482-2010-01016
    Event Type
    Injury
    Date Received
    December 20, 2010
    Date of Event
    November 28, 2010
    Report Date
    November 30, 2010
    Manufacturer
    HOSPIRA, INC.
    Product Code
    MEA
    PMA / PMN Number
    K042800
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS EXPECTED TO BE RETURNED FOR INVESTIGATION. IT HAS NOT YET BEEN RECEIVED. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED THAT PATIENT RECEIVED MORE MEDICATION THAN INTENDED. ON (B)(6) 2010 AT AN UNSPECIFIED TIME, THE PUMP WAS PROGRAMMED IN THE PCA ONLY MODE TO DELIVER DILAUDID 0.2 MG/ML, WITH A 0.2 MG LOADING DOSE, A 0.4 MG PCA DOSE, A 10 MINUTE PATIENT LOCKOUT, AND A 6 MG FOUR HOUR DOSE LIMIT. THE CUSTOMER CONTACT REPORTED THAT THE PATIENT WAS ALSO BEING TREATED WITH UNSPECIFIED CONCENTRATIONS OF OXYCODONE AND XANAX. ON (B)(6) 2010 AT 0710, DURING A NURSING PCA CHECK, THE PATIENT WAS FOUND IN AN "OVER SEDATED STATE." IT WAS REPORTED THE PATIENT WAS SLEEPY BUT COULD BE AROUSED. THE CUSTOMER REPORTED THE PATIENT'S RESPIRATORY RATE WAS 4 BREATHS PER MINUTE. AT UNSPECIFIED TIMES, IT WAS REPORTED THAT THE PATIENT'S OXYGEN SATURATION WAS BETWEEN 80% TO 100%. THE PATIENT WAS TREATED WITH NARCAN 0.4 MG AND OXYGEN THERAPY WAS INITIATED AT 6 L/MIN PER MASK. THE CUSTOMER STATED, "THE PATIENT IMMEDIATELY RETURNED TO NORMAL LEVEL OF CONSCIOUSNESS AND WAS EASILY AROUSABLE." THE PUMP WAS REMOVED FROM CLINICAL SERVICE. THERAPY WAS RESUMED USING A REPLACEMENT PUMP. ON (B)(6) 2010, THE PATIENT WAS CHANGED TO ORAL PAIN MEDICATION. THE CUSTOMER CONTACT REPORTED THE EVENT "COULD BE DUE TO HUMAN OR EQUIPMENT RELATED ISSUES OR THE CUMULATIVE EFFECTS OF THE MULTIPLE MEDICATIONS THE PATIENT WAS RECEIVING." THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    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 40 YR Life Threatening| R OXYCODONE: MANUFACTURER UNK| DILAUDID: MANUFACTURER UNK| XANAX: MANUFACTURER UNK