BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFECARE PCA 3 V 5.06

    MDR report key: 3070170 · Received April 15, 2013

    Report

    Report Number
    9615050-2013-00721
    Event Type
    Malfunction
    Date Received
    April 15, 2013
    Date of Event
    January 19, 2013
    Report Date
    March 19, 2013
    Manufacturer
    HOSPIRA COSTA RICA LTD.
    Product Code
    MEA
    PMA / PMN Number
    K042800
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT COMPLETE. THE DEVICE HISTORY WAS DOWNLOADED AT THE SERVICE CENTER. A REVIEW OF THE HISTORY INDICATES THAT ON THE CUSTOMER REPORTED EVENT DATE OF (B)(6) 2013 AT 1044, THE DEVICE WAS PROGRAMMED FOR PCA ONLY DELIVERY OF HYDROMORPHONE 1 MG/ML, CCA NMH, WITH A LOADING DOSE OF 0.5 MG, WITH A 15 MINUTE PCA LOCKOUT, NO DOSE LIMIT WAS SELECTED AND THE DOOR WAS LOCKED. BETWEEN 1045 AND 1046, A LOADING DOSE WAS DELIVERED AND THERE WAS ONE UNMET PT DEMAND. BETWEEN 1611 AND 2005, THERE WERE TWO 0.3 MG PT INITIATED DELIVERIES. BETWEEN 2059 AND 2105, THERE WERE 5 CHECK VIAL ALARMS, CHECK SETTINGS ALARMS, CHECK SYRINGE ALARMS, BAR CODE NOT READ ALARMS, THE DOOR WAS OPENED AND LOCKED 5 TIMES, THE PROGRAMMED SETTINGS WERE RETAINED AND CONFIRMED. BETWEEN 2233 AND 2251, THE DOOR WAS OPENED 4 TIMES, LOCKED 3 TIMES, AN OPEN DOOR ALARM OCCURRED, A CHECK SETTINGS ALARM OCCURRED 2 TIMES, A CHECK VIAL AND CHECK SYRINGE ALARM OCCURRED. AT 2251, THE DEVICE WAS POWERED OFF. REVIEW OF DEVICE HISTORY INDICATES THAT DEVICE DELIVERED AS PROGRAMMED. THIS REPORT REPRESENTS ALL THE INFO KNOWN BY THE REPORTER UPON QUERY BY HOSPIRA PERSONNEL.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED THE PT RECEIVED MORE MEDICATION THAN INTENDED. ON AN UNSPECIFIED DATE AND TIME, THE DEVICE WAS PROGRAMMED TO DELIVER AN UNSPECIFIED MEDICATION AND THE DELIVERY WAS STARTED. NO SPECIFIC PROGRAMMING PARAMETERS WERE PROVIDED. ON (B)(6) 2013 AT 2100, IT WAS REPORTED THE PT WAS LETHARGIC. NO SPECIFIC DETAILS WERE PROVIDED. DURING TESTING AT THE USER FACILITY, THE DEVICE PASSED TESTING FOR DELIVERY ACCURACY. THOUGH REQUESTED, THE CUSTOMER DECLINED TO PROVIDE ADD'L INFO, INCLUDING PUMP PROGRAMMING, SPECIFIC EVENT DETAILS, IF ANY MEDICAL INTERVENTIONS WERE REQUIRED AND THE PT OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    160886 LIFECARE PCA 3 V 5.06 80MEA MEA HOSPIRA COSTA RICA LTD. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK