BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIFECARE PCA PLUS INFUSER

    MDR report key: 1101893 · Received August 7, 2008

    Report

    Report Number
    2921482-2008-00244
    Event Type
    Injury
    Date Received
    August 7, 2008
    Date of Event
    June 11, 2008
    Report Date
    July 9, 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
    TX, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE HISTORY WAS DOWNLOADED AT THE MANUFACTURING FACILITY. A REVIEW OF THE HISTORY INDICATES THE ORIGINAL PUMP SETTINGS WITH PROGRAMMING PARAMETERS HAD SCROLLED OFF THE HISTORY. ON THERE REPORTED EVENT DATE OF 2008 BETWEEN 0044 & 0529, THERE WERE SEVEN 0.2 MG PT INITIATED DELIVERIES, THE DOOR WAS OPENED, A TOTAL OF 3.0 MG WAS CLEARED AND THE DOOR WAS LOCKED. BETWEEN 0536 & 1058, THERE WERE 14 0.2 MG PT INITIATED DELIVERIES, THE DOOR WAS OPENED, THERE WAS A VIAL ALARM, A CHECK SYRINGE ALARM, A DOOR ALARM, AND INJECTOR ALARM AND THE DOOR WAS LOCKED. BETWEEN 1109 & 1536, THERE WERE FIVE 0.2 MG PT INITIATED DELIVERIES & FOUR UNMET PT DEMANDS, THE DOOR WAS OPENED AND THERE WERE THREE VIAL ALARMS. AT 1537, THE DOOR WAS LOCKED, OPENED, THERE WERE 2 CHECK SYRINGE ALARMS, AN INJECTOR ALARM, 2 VIAL ALARMS, THE DOOR WAS LOCKED & OPENED. BETWEEN 1538 AND 1539, THE DOOR WAS LOCKED 2 TIMES, THE DOOR WAS OPENED 3 TIMES, THERE WAS A CHECK SYRINGE ALARM, AN INJECTOR ALARM, A 3.8MG TOTAL WAS CLEARED AND THE DOOR WAS LOCKED. BETWEEN 1546 AND 1614 THERE WERE EIGHT VIAL ALARMS, 11 CHECK SYRINGE ALARMS, 7 INJECTOR ALARMS, THE DOOR WAS OPENED FOUR TIMES AND LOCKED THREE TIMES AND THE PUMP WAS POWERED OFF. BETWEEN 1656 AND 1723, THERE WERE 5 CHECK SYRINGE ALARMS, 2 INJECTOR ALARMS, 1 CHECK SET ALARM, 6 VIAL ALARMS, THE DOOR WAS OPENED AND LOCKED FIVE TIMES. AT 1724, THE DOOR WAS LOCKED, OPENED, & POWERED OFF. A REVIEW OF THE HISTORY INDICATES THE DEVICE DELIVERED AS PROGRAMMED.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED THE PT RECEIVED MORE MEDICATION THAN INTENDED. ON AN UNSPECIFIED DATE AND TIME, THE PUMP WAS PROGRAMMED TO DELIVER HYDROMORPHONE 1 MG/ML IN THE PCA ONLY MODE, WITH A 0.2 MG PCA DOSE, A 6 MINUTE PT LOCKOUT, AND A 7 MG FOUR HOUR LIMIT. ON AN UNSPECIFIED DATE AND TIME, THE PT RECEIVED A 0.2 MG LOADING DOSE. IN 2008, AT 3 UNSPECIFIED TIMES, THE CUSTOMER CONTACT REPORTED THAT THE PUMP ALARMED AND EACH TIME THE NURSE ADJUSTED THE SYRINGE AND THE ALARM STOPPED. AFTER THE SYRINGE WAS ADJUSTED FOR THE THIRD TIME, THE NURSE NOTED THE SYRINGE WAS EMPTY AND THAT THE PT WAS REPORTED TO BE SEDATED. AT 1726, THE PT WAS TREATED WITH NALOXONE 0.4 MG AND WAS TRANSFERRED TO THE INTENSIVE CARE UNIT (ICU). THE CUSTOMER CONTACT REPORTED THAT THE NURSES IN THE ICU VERIFIED THAT THE PUMP WAS PROGRAMMED CORRECTLY. THE PUMP WAS REMOVED FROM CLINICAL SERVICE. THERE WERE NO REPORTED ADVERSE PT SEQUELAE. THOUGH REQUESTED, NO ADDITIONAL INFO 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 67 YR Life Threatening| R HYDROMORPHONE