BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LC PCA SW VERSION 1.

    MDR report key: 2182750 · Received July 11, 2011

    Report

    Report Number
    9615050-2011-00524
    Event Type
    Malfunction
    Date Received
    July 11, 2011
    Date of Event
    June 11, 2011
    Report Date
    June 16, 2011
    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
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS EXPECTED TO BE RETURNED FOR INVESTIGATION. IT HAS NOT YET BEEN RECEIVED. THE PUMP HISTORY WAS DOWNLOADED AT THE USER FACILITY. ON (B)(6) 2011, AT 0550, THE FOLLOWING PREVIOUSLY PROGRAMMED SETTINGS WERE RETAINED AND CONFIRMED, FENTANYL 50 MCG/ML IN THE PCA+CONTINUOUS MODE, WITH A 14 MCG/HR CONTINUOUS RATE, A 14 MCG PCA DOSE, A 6 MINUTE PT LOCKOUT AND NO DOSE LIMIT, DOOR WAS LOCKED AND INFUSION STARTED. BETWEEN 0620 AND 1035, THREE 14 MCG PT INITIATED DELIVERIES, INFUSION PAUSED ALARM AND INFUSION STARTED. AT 1048, OPERATING ON BATTERY AND ONE 14 MCG PT INITIATED DELIVERY. AT 1101, OPERATING ON AC. BETWEEN 1119 AND 1158, INFUSER PAUSED ALARM, INFUSION STARTED AND TWO 14 MCG PT INITIATED DELIVERIES. AT 1206, OPERATING ON BATTERY. BETWEEN 1214 AND 1215, INFUSER PAUSED ALARM, DOOR OPENED AND LOCKED AND INFUSION STARTED. AT 1216, OPERATING ON AC. BETWEEN 1253 AND 1431, THREE 14 MCG PT INITIATED DELIVERIES. BETWEEN 1512 AND 1623, OPERATING ON BATTERY AND THREE 14 MCG PT INITIATED DELIVERIES. AT 1626, OPERATING ON AC. BETWEEN 1702 AND 1908, FOUR 14 MCG PT INITIATED DELIVERIES, INFUSER PAUSED ALARM AND INFUSION STARTED. AT 1946, OPERATING ON BATTERY BETWEEN 1952 AND 1956, 2 INFUSER PAUSED ALARMS AND INFUSION STARTED TWICE. AT 2006, OPERATING ON AC. BETWEEN 2011 AND 2201, FIVE 14 MCG PT INITIATED DELIVERIES. AT 2201, OPERATING ON BATTERY. AT 2207, OPERATING ON AC. BETWEEN 2251 AND 0000, TWO 14 MCG PT INITIATED DELIVERIES AND NEW DATE STAMP OF (B)(6) 2011. AT 0347, OPERATING ON BATTERY. AT 0353, OPERATING ON AC. BETWEEN 0354 AND 0520, FOUR 14 MCG PT INITIATED DELIVERIES, 3 INFUSER PAUSED ALARMS, INFUSION STARTED TWICE, DOOR OPENED, 702 MCG SHIFT TOTAL CLEARED, ONE CHECK VIAL ALARM, 5 CHECK SYRINGE ALARMS, 4 BARCODE NOT READ ALARMS, A CHECK INJECTOR ALARM, PREVIOUSLY PROGRAMMED SETTINGS RETAINED AND CONFIRMED, DOOR LOCKED. BETWEEN 0528 AND 0744, TWO 14 MCG PT INITIATED DELIVERIES. AT 0753, OPERATING ON BATTERY. BETWEEN 0805 AND 0903, THREE 14 MCG PT INITIATED DELIVERIES, INFUSER PAUSED ALARM AND INFUSION STARTED. AT 0917, POWER LOSS ALARM. AT 0922, SET TIME AND DATE (B)(6) 2011 AND 124 MCG TOTAL CLEARED. A REVIEW OF THE PUMP HISTORY INDICATES, THE PUMP 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 THAT WHILE OPERATING ON AC POWER, THE PUMP POWERED OFF BY ITSELF WITHOUT SOUNDING AN AUDIBLE ALARM TONE. ON (B)(6) 2011, AT AN UNSPECIFIED TIME, THE PUMP WAS PROGRAMMED TO DELIVER FENTANYL 50 MCG/ML, IN THE PCA+CONTINUOUS MODE, WITH A 14 MCG/HR CONTINUOUS RATE, A 14 MCG PCA DOSE, A 6 MINUTE PT LOCKOUT, AND NO DOSE LIMIT AND THE DELIVERY WAS STARTED. THE CUSTOMER CONTACT REPORTED THAT ON (B)(6) 2011 AT 1000, THE PT'S PARENT CALLED THE NURSE TO REPORT THAT THE PT WAS IN PAIN AND WHEN THE PT PRESSED THE PT PENDANT, THERE WAS NO BEEP TO INDICATE A DOSE WAS BEING DELIVERED. AT THIS TIME, THE PARENT LOOKED AT THE DISPLAY AND NOTED THE SCREEN WAS DARK. WHEN THE NURSE ARRIVED AT THE PT'S ROOM, THE PUMP WAS NOTED TO BE PLUGGED INTO AC POWER AND POWERED OFF. IT WAS REPORTED THERE WAS NO ALARM. AT THIS TIME, THE PT REPORTED A PAIN LEVEL OF "5" ON A SCALE OF 1 TO 10. THE PUMP WAS REMOVED FROM CLINICAL SERVICE. THERAPY WAS RESUMED USING A REPLACEMENT PUMP. NO MEDICAL INTERVENTIONS WERE REQUIRED. AT AN UNSPECIFIED TIME, IT WAS REPORTED THAT THE PT'S PAIN LEVEL IMPROVED TO AN UNSPECIFIED LEVEL. DURING TESTING AT THE USER FACILITY, NO POWER LOSS WAS NOTED WHILE OPERATING ON AC POWER; HOWEVER, THE BATTERY WAS REPORTED AS "NOT MAINTAINING A CHARGE." THOUGH REQUESTED, NO ADD'L INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LC PCA SW VERSION 1. 80MEA MEA HOSPIRA COSTA RICA LTD. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1