BEUDAMED
    FDA Adverse Event Other Summary report: N

    PCA PLS II

    MDR report key: 1622136 · Received March 2, 2010

    Report

    Report Number
    2921482-2010-00099
    Event Type
    Other
    Date Received
    March 2, 2010
    Date of Event
    January 26, 2010
    Report Date
    February 1, 2010
    Manufacturer
    HOSPIRA, INC.
    Product Code
    MEA
    PMA / PMN Number
    K912928
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, 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 19.42 ML FROM AN EXPECTED DELIVERY OF 20 ML. DELIVERY ACCURACY FOR THIS DEVICE REQUIRES DELIVERY OF 20 ML +/- 1 ML (+/- 5%). THE HISTORY WAS DOWNLOADED AT THE MFG FACILITY. A REVIEW OF THE HISTORY INDICATES THAT ON (B)(6) 2010 AT 1048, THE DEVICE WAS PROGRAMMED IN THE PCA+CONTINUOUS MODE TO DELIVER AN UNSPECIFIED MEDICATION WITH A CONCENTRATION OF 0.8 MG/ML, WITH A CONTINUOUS RATE OF 0.8MG/HR, A 0.2MG PCA DOSE, A 15 MIN PT LOCKOUT, AN 8.0MG FOUR HOUR LIMIT AND THE DELIVERY WAS STARTED. NEW DATE STAMP OF (B)(6)2010. AT 0507, A 0.2MG PT INITIATED DELIVERY. AT 0732, EMPTY SYRINGE ALARM OCCURRED. AT 0742, 63.5 MG TOTAL CLEARED... NEW DATE STAMP (B)(6) 2010. AT 1145 EMPTY SYRINGE ALARM OCCURRED. AT 0338, PUMP WAS REPROGRAMMED TO DELIVER A DRUG CONCENTRATION OF 1.0MG/ML WITH NO FOUR HOUR LIMIT SELECTED AND THE DELIVERY WAS RESUMED. NEW DATE STAMP (B)(6) 2010. BETWEEN 1203 AM AND 1221 PM, THERE WERE 6 0.2MG PT INITIATED DELIVERIES AND 4 UNMET PT DEMANDS. AT 0506, EMPTY SYRINGE ALARM OCCURRED. NEW DATE STAMP (B)(6) 2010. BETWEEN 0455 AND 0954, THERE WERE 6 0.2MG PT INITIATED DELIVERIES. NEW DATE STAMP (B)(6) 2010. AT 0507, EMPTY SYRINGE ALARM OCCURRED. BETWEEN 0516 AND 0520, 2 INFUSION RESTART ALARMS, 1 VIAL ALARM, 3 CHECK SYRINGE ALARMS, 1 DOOR ALARM, 2 INJECTOR ALARMS, DOOR OPENED AND LOCKED, AND START INFUSION. BETWEEN 0723 AND 1017, THERE WERE TWO 0.2MG PT INITIATED DELIVERIES, 2 OCCLUSION ALARMS, 3 VIAL ALARMS, 3 CHECK SYRINGE ALARMS, 2 INJECTOR ALARMS, 2 START INFUSIONS, 2 DOORS OPENED AND 1 DOOR LOCKED, AND POWERED OFF. AT 1018, CHECK SYRINGE ALARM AND EMPTY SYRINGE ALARM AND THE DEVICE WAS POWERED OFF. AT 1101, A CHECK SYRINGE ALARM AND AN EMPTY SYRINGE ALARM OCCURRED AND THE PUMP WAS POWERED OFF. THIS REPORT REPRESENTS ALL THE INFO KNOWN BY THE REPORTER UPON BY HOSPIRA PERSONNEL. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED AN OPERATOR ERROR IN PROGRAMMING THE DEVICE, WHICH RESULTED IN THE PT RECEIVING MORE MEDICATION THAN INTENDED. THE CUSTOMER CONTACT REPORTED ON (B)(6) 2010, AN ORDER WAS WRITTEN BY THE PHYSICIAN FOR THE PT TO RECEIVE AN UNSPECIFIED CONCENTRATION OF DILAUDID, IN THE PCA+ CONTINUOUS MODE, WITH A CONTINUOUS RATE OF 1 MG/HR, A PCA DOSE OF 0.25MG, A 15 MIN PT LOCKOUT, AND A 12MG FOUR HOUR DOSE LIMIT. REPORTEDLY, THE PUMP WAS PROGRAMMED TO DELIVER THE DILAUDID; HOWEVER, NO SPECIFIC PROGRAMMING PARAMETERS WERE PROVIDED. ON (B)(6) 2010 AT 1151, THE CUSTOMER CONTACT REPORTED THE PT RECEIVED "ALL 30 CC OF DILAUDID IN 2 HOURS. WITH HER ORDERS IF SHE HIT THE BUTTON EVERY TIME SHE COULD HAVE, SHOULD HAVE LASTED SIX HOURS ACCORDING TO PHARMACY." THE CUSTOMER CONTACT INDICATED THAT THE PT HAD NO EFFECTS AND NO MEDICAL INTERVENTIONS WERE REQUIRED. THE DEVICE WAS REMOVED FROM CLINICAL SERVICE. THE CUSTOMER CONTACT REPORTED, "THE HISTORY DOES NOT MATCH THE PHYSICIAN ORDERS" AND "FOR AN UNSPECIFIED REASON, THE NURSE MUST HAVE BEEN PROGRAMMING IT DIFFERENTLY." THOUGH REQUESTED, NO ADD'L INFO WAS PROVIDED INCLUDING PUMP PROGRAMMING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PCA PLS II 80FRN MEA HOSPIRA, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK