BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFECARE PCA 3 V5.06

    MDR report key: 1931744 · Received November 22, 2010

    Report

    Report Number
    2921482-2010-00934
    Event Type
    Malfunction
    Date Received
    November 22, 2010
    Date of Event
    November 3, 2010
    Report Date
    November 4, 2010
    Manufacturer
    HOSPIRA, INC.
    Product Code
    MEA
    PMA / PMN Number
    K042800
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS EXPECTED TO BE RETURNED FOR INVESTIGATION. IT HAS NOT YET BEEN RECEIVED. THIS REPORT REPRESENTS ALL THE INFO KNOWN BY THE REPORTER UPON QUERY BY HOSPIRA PERSONNEL. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED THE PATIENT RECEIVED MORE MEDICATION THAN INTENDED. ON AN UNSPECIFIED DATE AND TIME, THE PUMP WAS PROGRAMMED TO DELIVER DILAUDID 1MG/ML, IN THE PCA+CONTINUOUS MODE, WITH A 0.4MG/HR CONTINUOUS RATE, A 0.2MG PCA DOSE, A 10 MINUTES PATIENT LOCKOUT, AN UNSPECIFIED 4 HOURS LIMIT, AND THE DELIVERY WAS STARTED. THE CUSTOMER CONTACT REPORTED AT 1800, A NEW VIAL WAS INSERTED IN THE PUMP. AT 1930 DURING A ROUTINE PUMP CHECK AT CHANGE OF SHIFT, THE DISPLAY INDICATED 1ML HAD BEEN DELIVERED; HOWEVER, THE CUSTOMER CONTACT REPORTED THERE WAS 22ML OF MEDICATION REMAINING IN THE VIAL INSTEAD OF THE EXPECTED 29ML. THERE WERE NO REPORTED ADVERSE PT EFFECTS AND THE PUMP REMAINED IN CLINICAL USE. AT 2035, THE CUSTOMER CONTACT REPORTED THE DISPLAY INDICATED THAT 1.4ML HAD BEEN DELIVERED; HOWEVER, 18ML REMAINED IN THE VIAL INSTEAD OF THE EXPECTED 28.6ML. THE DEVICE WAS REMOVED FROM CLINICAL SERVICE. THERAPY WAS RESUMED USING A REPLACEMENT PUMP AND NEW TUBING SET. THE PHYSICIAN WAS NOTIFIED. THE CUSTOMER CONTACT REPORTED, " THERE WAS NO CHANGE IN THE CLINICAL STATUS." 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 LIFECARE PCA 3 V5.06 80MEA MEA HOSPIRA, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR