BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LC PCA NEW 802.11 AB

    MDR report key: 1884025 · Received October 14, 2010

    Report

    Report Number
    2921482-2010-00787
    Event Type
    Injury
    Date Received
    October 14, 2010
    Date of Event
    September 2, 2010
    Report Date
    September 15, 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
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON 10/06/2010, A FIELD SERVICE ENGINEER PERFORMED TESTING AND INVESTIGATION AT THE USER FACILITY. THE DEVICE PASSED TESTING FOR DELIVERY ACCURACY. DURING TESTING, THE DEVICE DELIVERED A MEASURED VOLUME OF 20.0 ML FROM AN EXPECTED DELIVERY OF 20.0 ML. DELIVERY ACCURACY FOR THIS DEVICE REQUIRES A DELIVERY OF 20ML (+/- 5%). BASED ON THE DATA VERIFIED, HOSPIRA COULD NOT ATTRIBUTE THE ISSUE TO THE DEVICE. THE DEVICE HISTORY WAS DOWNLOADED AT THE USER FACILITY. ON (B)(6) 2010 BETWEEN 1921 AND 1923, THE PUMP WAS PROGRAMMED, AS REPORTED BY THE CUSTOMER, IN THE PCA+CONTINUOUS MODE, WITH A 0.4 MG PCA DOSE, A 15 MINUTE PCA LOCKOUT, A 0.8MG/HR CONTINUOUS RATE, NO SET DOSE LIMIT, THE SETTINGS WERE CONFIRMED, THE DOOR LOCKED, THE INFUSION STARTED AND THERE WAS ONE 0.4MG PATIENT INITIATED DELIVERY. BETWEEN 1948 AND 2005, THERE WERE TWO 0.4 MG PT INITIATED DELIVERIES AND 3 UNMET PT DEMANDS. BETWEEN 2226 AND 2230, THERE WAS 1 OCCLUSION ALARM, 2 INFUSER PAUSE ALARMS, 1 CHECK SYRINGE ALARM, 1 CHECK INJECTOR ALARM, HYDROMORPHONE 1MG/ML WAS CONFIRMED, THE DOOR WAS OPENED TWICE AND LOCKED ONCE. AT 2231, THE PUMP WAS REPROGRAMMED USING THE SAME PROGRAMMING PARAMETERS, THE SETTINGS WERE CONFIRMED, THE DOOR LOCKED, AND THE INFUSION STARTED. BETWEEN 2237 AND 2329, THERE WERE TWO 0.4MG PATIENT INITIATED DELIVERIES. AT 0000, A NEW DATE STAMP OF (B)(6) 2010 OCCURRED. BETWEEN 0003 AND 0006, THERE WAS ONE 0.1MG PATIENT INITIATED DELIVERY, 1 OCCLUSION ALARM, 1 INFUSER PAUSED ALARM, 2 CHECK VIAL ALARMS, 3 BAR CODE NOT READ ALARMS, 1 CHECK SETTINGS ALARM, 1 CHECK INJECTOR ALARM, THE DOOR WAS OPENED AND LOCKED TWICE, THE PUMP WAS POWERED OFF AND THEN ON, NEW PATIENT NOT SELECTED, CCA ADULT STANDARD SET, THE PUMP REPROGRAMMED USING THE SAME PROGRAMMING PARAMETERS, THE SETTINGS WERE CONFIRMED, AND THE INFUSION STARTED. BETWEEN 0007 AND 0016, THERE WERE 4 UNMET PT DEMANDS. AT 0017, THE DOOR WAS OPENED, A 0.5 MG LOADING DOSE DELIVERED, AND THE DOOR WAS LOCKED. AT 0018, THE PUMP WAS REPROGRAMMED WITH A 10 MINUTE PCA LOCKOUT, THE SETTINGS WERE CONFIRMED, THE DOOR WAS LOCKED, THE INFUSION STARTED, AND THERE WAS 1 UNMET PATIENT DEMAND. BETWEEN 0031 AND 0112, THERE WAS ONE 0.4MG PT INITIATED DELIVERY, 2 UNMET PT DEMANDS, AND THE DOOR WAS OPENED. A REVIEW OF THE DEVICE HISTORY INDICATES THE DEVICE DELIVERED AS PROGRAMMED. THIS REPORT REPRESENTS ALL THE INFO KNOWN BY THE REPORTER UPON QUERY BY HOSPIRA PERSONNEL. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED THE PATIENT RECEIVED LESS MEDICATION THAN INTENDED. ON AN UNSPECIFIED DATE AND TIME, THE PUMP WAS PROGRAMMED TO DELIVER IN THE PCA+CONTINUOUS MODE HYDROMORPHONE 1MG/ML WITH A 0.8MG/HR CONTINUOUS RATE, A 0.4MG PCA DOSE, A 15 MINUTE LOCKOUT, AND NO 4 HOUR LIMIT. THE CUSTOMER CONTACT REPORTED THAT AT 0030, THE DISPLAY INDICATED "7ML HAD INFUSED, BUT THE SYRINGE VOLUME HAD ONLY CHANGED BY 0.5ML." IT WAS REPORTED THAT THE MEDICATION IN THE VIAL WAS AT THE 28ML MARK INSTEAD OF THE 21.5ML MARK AS EXPECTED. THE CUSTOMER CONTACT REPORTED, "THE PATIENT'S PAIN WAS NOT UNDER CONTROL AT THIS TIME." THE PHYSICIAN WAS NOTIFIED. AT AN UNSPECIFIED TIME, THE PATIENT WAS TREATED WITH A 0.5MG HYDROMORPHONE LOADING DOSE AND AN UNSPECIFIED DOSE OF BENADRYL DUE TO INCREASED ANXIETY. THE DEVICE WAS REMOVED FROM CLINICAL SERVICE. THERAPY WAS RESUMED USING A REPLACEMENT DEVICE. THOUGH REQUESTED, NO ADD'L INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LC PCA NEW 802.11 AB 80MEA MEA HOSPIRA, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR Required Intervention HYDROMORPHONE, MFR: UNK