BEUDAMED
    FDA Adverse Event Death Summary report: N

    LIFECARE PCA WITH MEDNET

    MDR report key: 1219283 · Received November 3, 2008

    Report

    Report Number
    2921482-2008-00352
    Event Type
    Death
    Date Received
    November 3, 2008
    Date of Event
    October 6, 2008
    Report Date
    October 8, 2008
    Manufacturer
    HOSPIRA, INC.
    Product Code
    MEA
    PMA / PMN Number
    K042800
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE PASSED TESTING FOR DELIVERY ACCURACY. THE CUSTOMER CONTACT INDICATED THE EVENT WAS THE RESULT OF AN OPERATOR ERROR IN PROGRAMMING THE DEVICE. THE HISTORY WAS DOWNLOADED AT THE MFG FACILITY. A REVIEW OF THE HISTORY INDICATED IN 2008 AT 1209, THE PUMP WAS POWERED ON AND THE HISTORY WAS CLEARED. AT 1212, THE PUMP WAS PROGRAMMED TO DELIVER A 1 MG/ML DRUG CONCENTRATION IN THE PCA ONLY MODE, WITH A 0.7 MG PCA DOSE INSTEAD OF THE INTENDED 0.2MG PCA DOSE, A 6 MIN PT LOCKOUT, AN 8MG 4 HOUR LIMIT AND THE DOOR WAS LOCKED. BETWEEN 1307 AND 1609, THERE WERE NINE 0.7 MG PCA DOSES AND ONE UNMET PT DEMAND. AT 1719, THE DOOR WAS OPENED AND THE PUMP WAS POWERED OFF. AT 2212, THE PUMP WAS POWERED ON, A 7MG TOTAL WAS CLEARED, AND THE PUMP WAS POWERED OFF. REVIEW OF THE HISTORY INDICATES THE PUMP DELIVERED AS PROGRAMMED.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED AN OPERATOR ERROR IN PROGRAMMING THE PUMP, WHICH RESULTED IN THE PT RECEIVING MORE MEDICATION THAN INTENDED. AT AN UNSPECIFIED TIME IN THE POST ANESTHESIA CARE UNIT, THE PUMP WAS PROGRAMMED TO DELIVERY HYDROMORPHONE 1 MG/ML, IN THE PCA ONLY MODE, WITH A 0.2 MG PCA DOSE, A 6 MIN PT LOCKOUT, AND AN 8MG 4 HOUR LIMIT. AT APPROX 1800, THE PT'S WIFE NOTIFIED THE NURSE THAT SHE HAD FOUND THE PT "UNRESPONSIVE AND HIS COLOR UNNATURAL." THE CUSTOMER CONTACT REPORTED THAT A CODE WAS CALLED; HOWEVER, NO SPECIFIC MEDICAL INTERVENTIONS WERE PROVIDED. AFTER AN UNSPECIFIED LENGTH OF TIME, THE PT WAS PLACED ON "LIFE SUPPORT" AND TRANSFERRED TO THE CRITICAL CARE UNIT. THE PUMP WAS REMOVED FROM CLINICAL SERVICE. IN 2008, THE PT WAS REMOVED FROM LIFE SUPPORT, AND SUBSEQUENTLY EXPIRED. UPON REVIEW OF THE HISTORY BY THE CUSTOMER CONTACT, IT WAS NOTED THE PUMP WAS PROGRAMMED TO DELIVER A 0.7MG PCA DOSE, INSTEAD OF THE INTENDED 0.2 MG PCA DOSE. THE CUSTOMER CONTACT STATED "THAT IS ACTUALLY A MISTAKE, THE PROGRAMMING SHOULD HAVE BEEN 0.2 MG." THOUGH REQUESTED, NO ADDITIONAL INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFECARE PCA WITH MEDNET MEA HOSPIRA, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Death HYDROMORPHONE