BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LC PCA HOSPIRA MEDNE

    MDR report key: 2316600 · Received October 6, 2011

    Report

    Report Number
    9615050-2011-00758
    Event Type
    Malfunction
    Date Received
    October 6, 2011
    Date of Event
    September 13, 2011
    Report Date
    September 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
    NE, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE PASSED TESTING FOR DELIVERY ACCURACY. DURING TESTING THE DEVICE DELIVERED A MEASURED VOLUME OF 19.62ML FROM AN EXPECTED DELIVERY OF 20ML. DELIVERY ACCURACY FOR THIS DEVICE REQUIRES A DELIVERY OF 20ML +/-1ML (+/-5%). BASED ON THE DATA VERIFIED HOSPIRA COULD NOT ATTRIBUTE THE ISSUE TO THE DEVICE. PUMP HISTORY DOWNLOADED AT THE SERVICE CENTER. REVIEW OF HISTORY INDICATES ON (B)(6) 2011 AT 1756, PUMP WAS POWERED ON, THERE WAS A CHECK SYRINGE ALARM, A 0.9MG TOTAL AND HISTORY CLEARED. BETWEEN 1757 AND 1758, CCA OPIOID TOLERANT SET, MORPHINE 1MG/ML CONFIRMED, DOOR OPENED AND POWERED OFF. BETWEEN 1909 AND 1910, HISTORY CLEARED, NEW PT SELECTED, CCA OPIOID NAIVE SET AND PUMP POWERED OFF. BETWEEN 1912 AND 1924, PUMP POWERED ON, HISTORY CLEARED, NEW PT SELECTED, CCA OPIOID TOLERANT SET, PUMP PROGRAMMED TO DELIVER MORPHINE 1MG/ML, IN PCA ONLY MODE, WITH A 1MG PCA DOSE, A 30 MINUTE PCA LOCKOUT, AN 8MG 4HR LIMIT, THERE WAS A DOOR OPEN ALARM, DOOR LOCKED AND OPENED, A 0MG LOADING DOSE SET, THERE WAS A 0.1MG LD LHL ALERT, PUMP POWERED OFF. BETWEEN 1925 AND 1937, PUMP POWERED ON X4, POWERED OFF X3, HISTORY CLEARED X4, NEW PT SELECTED X4, PUMP PROGRAMMED X3 USING PREVIOUSLY PROGRAMMED PARAMETERS, SETTINGS CONFIRMED X3. BETWEEN 1938 AND 1945, CCA OPIOID NAIVE SET, PUMP PROGRAMMED X2 USING PREVIOUSLY PROGRAMMED PARAMETERS, SETTINGS CONFIRMED AND DOOR LOCKED. BETWEEN 2002 AND 2346, THERE WERE THREE 1MG PT INITIATED DELIVERIES, ONE 0.8MG PT INITIATED DELIVERIES, AN OCCLUSION ALARM, 3 UNMET PT DEMANDS AND DOOR OPENED AND LOCKED X2. AT 0000, NEW DATE STAMP OF (B)(6) 2011. BETWEEN 0001 AND 1313, THERE WERE SEVEN 1MG PT INITIATED DELIVERIES, TWO 0.1MG PT INITIATED DELIVERIES, ONE 0.8MG PT INITIATED DELIVERY, 3 OCCLUSION ALARMS, CHECK VIAL ALARM, CHECK SYRINGE ALARM, A 7.9MG SHIFT TOTAL CLEARED, DOOR OPENED X6, LOCKED X5 AND PUMP POWERED OFF. REVIEW OF THE HISTORY INDICATES 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 THE PT RECEIVED LESS MEDICATION THAN INTENDED. ON (B)(6) 2011 AT 1756, THE PUMP WAS PROGRAMMED TO DELIVER MORPHINE SULFATE 1MG/ML IN A 30ML VIAL, IN THE PCA ONLY MODE, WITH A 1MG PCA DOSE, A 30 MINUTE PT LOCKOUT, AND AN 8MG 4 HOUR DOSE LIMIT. ON (B)(6) 2011 AT 0617, THE CUSTOMER CONTACT REPORTED THAT THE DISPLAY INDICATED 7.9MG HAD BEEN DELIVERED AND THE TOTALS WERE CLEARED. AT 1530, THE PCA THERAPY WAS DISCONTINUED. AT THIS TIME, THE CUSTOMER CONTACT REPORTED THE DISPLAY INDICATED 4.1MG HAD BEEN DELIVERED. HOWEVER, THE CUSTOMER CONTACT REPORTED THAT WHEN THE NURSE WASTED THE MEDICATION, 29MG WERE REMAINING IN THE VIAL INSTEAD OF 26MG AS EXPECTED. THE CUSTOMER CONTACT REPORTED THE PT'S PAIN WAS "UNDER CONTROL." THE PUMP WAS REMOVED FROM CLINICAL SERVICE. DURING TESTING AT THE USER FACILITY, THE DEVICE PASSED TESTING. THERE WERE NO REPORTED ADVERSE PT EFFECTS AND NO REPORTED DELAY OF THERAPY CRITICAL TO THIS PT. NO MEDICAL INTERVENTIONS WERE REQUIRED. THOUGH REQUESTED, NO ADD'L INFO WAS PROVIDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK