BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LC PCA III INFUSER

    MDR report key: 2143065 · Received June 23, 2011

    Report

    Report Number
    9615050-2011-00450
    Event Type
    Injury
    Date Received
    June 23, 2011
    Date of Event
    May 24, 2011
    Report Date
    May 26, 2011
    Manufacturer
    HOSPIRA COSTA RICA LTD.
    Product Code
    MEA
    PMA / PMN Number
    K043256
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT COMPLETE. PUMP HISTORY DOWNLOADED AT THE SERVICE CENTER. REVIEW OF PUMP HISTORY INDICATES ON (B)(6) 2011, BETWEEN 1327 AND 1328, POWERED ON, 2 CHECK INJECTOR ALARMS, 2 CHECK SYRINGE ALARMS, BAR CODE NOT READ ALARM, CHECK VIAL ALARM, TOTALS CLEARED 30.4MG, CONFIRM CUSTOM VIAL, HISTORY CLEARED AND PUMP PROGRAMMED TO DELIVER A DRUG CONCENTRATION OF 50MCG/ML, IN THE PCA ONLY MODE, WITH A 15MCG PCA DOSE, A 10MIN PATIENT LOCKOUT AND A 300MCG FOUR HOUR LIMIT, DOOR LOCKED AND ONE 15MCG PATIENT INITIATED DELIVERY. BETWEEN 1339 AND 2231, THERE WERE THIRTY-TWO 15MCG PATIENT INITIATED DELIVERIES, 31 UNMET PATIENT DEMANDS AND DOOR OPENED. BETWEEN 2232 AND 2256, PUMP WAS REPROGRAMMED IN THE PCA+CONTINUOUS MODE WITH A 10MCG/HR CONTINUOUS RATE, DOOR LOCKED, INFUSER PAUSED ALARM AND 2 START INFUSION. AT 0000, NEW DAY STAMP (B)(6) 2011. BETWEEN 0014 AND 0856, THERE WERE FOURTEEN 15MCG PATIENT INITIATED DELIVERIES, 18 UNMET PATIENT DEMANDS AND PUMP POWERED OFF. AT 1540, TOTALS CLEARED 816MCG. THIS REPORT REPRESENTS ALL THE INFORMATION KNOWN BY THE REPORTER UPON QUERY BY HOSPIRA PERSONNEL.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED THE DEVICE DID NOT DELIVER. ON (B)(6) 2011, AT 1315, THE PUMP WAS PROGRAMMED TO DELIVER A 20ML VIAL OF FENTANYL 50MCG/ML, IN THE PCA+CONTINUOUS MODE, WITH A 10MCG/HR CONTINUOUS RATE, A 15MCG PCA DOSE, A 10MINUTE PATIENT LOCKOUT, AND A 300MCG FOUR HOUR DOSE LIMIT AND THE DELIVERY WAS STARTED. ON (B)(6) 2011, AT 0847, THE NURSE NOTED THAT 18ML REMAINED IN THE VIAL; HOWEVER, THE PUMP DISPLAY INDICATED THAT 779MCG HAD BEEN DELIVERED. THE CUSTOMER CONTACT STATED, "THE DISPLAY WAS INCREMENTING AS IF DELIVERING BUT THERE WAS NO DELIVERY. THE SYRINGE REMAINED FULL." AT THIS TIME, THE PATIENT REPORTED A PAIN LEVEL OF 7 ON A SCALE OF 1 TO 10. THE PHYSICIAN WAS NOTIFIED. THE PHYSICIAN ORDERED THE PCA THERAPY BE DISCONTINUED AND SWITCHED THE PATIENT TO ORAL OXYCONTIN AND OXYCODONE AS NEEDED. THE CUSTOMER REPORTED THAT WHEN THE PATIENT WAS "PROPERLY MEDICATED ON THE ORAL PAIN MEDICATION, THE PATIENT'S PAIN WAS CONTROLLED." THE DEVICE WAS REMOVED FROM CLINICAL SERVICE. DURING TESTING AT THE USER FACILITY, THE DEVICE PASSED TESTING FOR DELIVERY ACCURACY; HOWEVER, THE DEVICE DID NOT ALARM WHEN A DISTAL OCCLUSION WAS PRESENT. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Required Intervention FENTANYL, MANUFACTURER UNK