BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PCA PLS II

    MDR report key: 3192207 · Received June 20, 2013

    Report

    Report Number
    9615050-2013-01701
    Event Type
    Malfunction
    Date Received
    June 20, 2013
    Date of Event
    May 20, 2013
    Report Date
    May 21, 2013
    Manufacturer
    HOSPIRA COSTA RICA LTD.
    Product Code
    FRN
    PMA / PMN Number
    K912928
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT COMPLETE. THE DEVICE HISTORY WAS DOWNLOADED AT THE SERVICE CENTER. THE INITIAL DEVICE PROGRAMMING WAS OVERWRITTEN BY NEWER INFORMATION. ON (B)(6) 2013 AT 1821, AN EMPTY SYRINGE ALARM WAS NOTED. BETWEEN 0628 AND 0631, THE DOOR WAS OPENED TWICE, THERE WAS ONE VIAL ALARM, 3 CHECK SYRINGE ALARMS, 3 INJECTOR ALARMS, A 7.2 MG TOTAL WAS CLEARED AND THE DOOR WAS LOCKED TWICE. BETWEEN 1850 AND 2350, THERE WERE 5 0.3 MG PT INITIATED PCA DELIVERIES AND 5 UNMET DEMANDS. ON (B)(6) 2013, NEW DAY STAMP. BETWEEN 1207 AND 2348, 8 UNMET DEMANDS AND 7 VIAL ALARMS. ON (B)(6) 2013, A NEW STAMP OCCURRED. BETWEEN 1323 AND 0537, THERE WERE 5, 0.3 MG PT INITIATED PCA DELIVERIES AND 2 UNMET DEMANDS, AND AN EMPTY SYRINGE ALARM OCCURRED. AT 0554, THE DOOR WAS OPENED, THERE WERE 3 VIAL ALARMS, 3 EMPTY SYRINGE ALARMS, 1 CHECK SYRINGE ALARM, AND THE DEVICE WAS TURNED OFF. THIS REPORT REPRESENTS ALL THE INFORMATION KNOWN BY THE REPORTER UPON QUERY BY HOSPIRA PERSONNEL.

    Description of Event or Problem · 1

    HOLD - AB 07/02/2013THE CUSTOMER CONTACT REPORTED THE PT RECEIVED MORE MEDICATION THAN INTENDED. ON (B)(6) 2013, AT AN UNSPECIFIED TIME, THE DEVICE WAS PROGRAMMED TO DELIVER HYDROMORPHONE 1 MG/ML, IN THE PCA ONLY MODE, WITH A 0.3 MG PCA DOSE, A 15 MINUTE PT LOCKOUT, AND A 2 MG 4 HOUR LOCK OUT, AND THE DELIVERY WAS STARTED. ON (B)(6) 2013 AT 0530, IT WAS REPORTED THE NURSE FOUND THE DEVICE WAS ALARMING FOR AN EMPTY SYRINGE; HOWEVER, THE DEVICE DISPLAYED THAT 7.2 MG HAD BEEN DELIVERED. THE DEVICE WAS REMOVED FROM CLINICAL SERVICE. THERAPY WAS RESUMED USING A REPLACEMENT DEVICE. THERE WERE NO REPORTED ADVERSE PT EFFECTS. NO MEDICAL INTERVENTIONS WERE REQUIRED. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    281492 PCA PLS II 80FRN FRN HOSPIRA COSTA RICA LTD. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR