BEUDAMED
    FDA Adverse Event Other Summary report: N

    LIFECARE PCA PLUS INFUSER

    MDR report key: 1200196 · Received October 6, 2008

    Report

    Report Number
    2921482-2008-00314
    Event Type
    Other
    Date Received
    October 6, 2008
    Date of Event
    September 8, 2008
    Report Date
    September 10, 2008
    Manufacturer
    HOSPIRA, INC.
    Product Code
    MEA
    PMA / PMN Number
    K895710
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AT THIS TIME THE CUSTOMER WILL NOT BE RETURNING THE DEVICE FOR EVALUATION. THE CUSTOMER CONTACT INDICATED THE EVENT WAS THE RESULT OF AN OPERATOR ERROR. THE DEVICE PASSED TESTING AT THE USER FACILITY.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED INADVERTENT DELIVERY DUE TO SYRINGE MANIPULATION. AT 1200, THE PUMP WAS PROGRAMMED TO DELIVER DILAUDID 0.4MG/ML IN THE PCA ONLY MODE "AT A RATE OF 0.2MG/HR," WITH A "4" MINUTE PATIENT LOCKOUT, AND "A DOSE LIMIT OF 3MG." NO FURTHER PROGRAMMING PARAMETERS WERE PROVIDED. AT 1430, THE NURSE NOTED THE PATIENT'S "AFFECT HAD CHANGED CONSIDERABLY." AT THIS TIME, IT WAS REPORTED THAT THE DISPLAY INDICATED 0.8MG HAD BEEN DELIVERED; HOWEVER, THE SYRINGE INDICATED 4ML HAD BEEN DELIVERED INSTEAD OF THE EXPECTED 2ML. THE DELIVERY WAS STOPPED. THE PHYSICIAN WAS NOTIFIED. THE PUMP WAS REMOVED FROM CLINICAL SERVICE. THERAPY WAS "HELD UNTIL LATER IN THE EVENING" WHEN IT WAS RESUMED USING A REPLACEMENT PUMP. NO MEDICAL INTERVENTIONS WERE REQUIRED. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELAE. THE CUSTOMER CONTACT STATED THE EVENT, "WAS DUE TO A USER ERROR WHEN MANIPULATING THE SYRINGES." DURING TESTING AT THE USER FACILITY, THE DEVICE PASSED TESTING. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFECARE PCA PLUS INFUSER 80-FRN MEA HOSPIRA, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Other DILAUDID