BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIFECARE PCA PLUS INFUSER

    MDR report key: 1003532 · Received February 26, 2008

    Report

    Report Number
    2921482-2008-00068
    Event Type
    Injury
    Date Received
    February 26, 2008
    Date of Event
    January 17, 2008
    Report Date
    January 31, 2008
    Manufacturer
    HOSPIRA, INC.
    Product Code
    FRN
    PMA / PMN Number
    K895710
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    AT THIS TIME, THE CUSTOMER WILL NOT BE RETURNING THE PUMP FOR EVALUATION. IF THE PUMP IS RECEIVED, A FOLLOW-UP REPORT WILL BE SUBMITTED. DURING TESTING AT THE USER FACILITY, THE DEVICE PASSED TESTING; HOWEVER, THE CUSTOMER CONTACT INDICATED THAT THERE WAS, "A WHITE BUILD-UP ON THE DOOR" AND LIQUID NOTED INSIDE THE PUMP DOOR.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED THE PATIENT RECEIVED MORE MEDICATION THAN INTENDED. AT 1445, THE PUMP WAS PROGRAMMED TO DELIVER HYDROMORPHONE 0.4MG/ML IN THE PCA+ CONTINUOUS MODE, WITH A 0.1MG/HR CONTINUOUS RATE, A 0.2MG PCA DOSE, AND A 10 MINUTE PATIENT LOCKOUT. NO FURTHER PROGRAMMING PARAMETERS WERE PROVIDED. THE CUSTOMER CONTACT REPORTED THE PROGRAMMING WAS CONFIRMED BY TWO NURSES AND THE DELIVERY WAS INITIATED. AT 1600, THE NURSE RETURNED TO THE PATIENT'S ROOM AND NOTED THE PATIENT WAS DIFFICULT TO AROUSE. THE PUMP DISPLAY "SHOWED 0.0MG FOR DOSE ACCUMULATED", AND THE AMOUNT LEFT IN THE VIAL INDICATED THAT "14ML/5.6MG HAD BEEN DELIVERED". THE PATIENT WAS REPORTED TO HAVE OXYGEN DESATURATION, DECREASED RESPIRATIONS, AND WAS SOMNOLENT. THE PATIENT WAS TREATED WITH AN UNSPECIFIED TYPE OF OXYGEN THERAPY, WAS MONITORED WITH CONTINUOUS PULSE OXIMETRY, AND VITAL SIGNS WERE TAKEN EVERY 15 MINUTES. AFTER AN UNSPECIFIED LENGTH OF TIME, THE PATIENT WAS AROUSABLE. THE PUMP WAS REMOVED FROM CLINICAL SERVICE. THERE WERE NO REPORTED ADVERSE PATIENT SEQUELAE. DURING TESTING AT THE USER FACILITY, THE PUMP PASSED TESTING; HOWEVER, THE CUSTOMER CONTACT INDICATED THAT THERE WAS, "A WHITE BUILD-UP ON THE DOOR" AND LIQUID NOTED INSIDE THE PUMP DOOR. 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 FRN HOSPIRA, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Life Threatening| R HYDROMORPHONE, MANUFACTURER UNK