BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFECARE PLUM PUMP MODEL 5000

    MDR report key: 602281 · Received May 4, 2005

    Report

    Report Number
    2921482-2005-00257
    Event Type
    Malfunction
    Date Received
    May 4, 2005
    Date of Event
    February 14, 2005
    Report Date
    April 13, 2005
    Manufacturer
    HOSPIRA, INC.
    Product Code
    FRN
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    "THE PT'S PUMP HAD BEEN INFUSING HEPARIN AT 20CC/HR. WHEN THE NURSE CHECKED THE HEPARIN BAG IT WAS DRY. THE HEPARIN CASSETTE HAD FLIPPED AND MORE THAN 3/4 OF THE HEPARIN HAD INFUSED OVER 90 MINUTES. THE PUP DOOR WAS FOUND OPEN ALLOWING A FREE FLOW OF IV FLUID. THE PT RECEIVED APPROX. 250 CC WITHIN THIS TIME FRAME. THE PT STATED THEY DO NOT KNOW WHO FLIPPED THE IV. THE PUMP WAS TESTED INTERNALLY AND WAS FOUND TO BE FUNCTIONING PROPERLY. NO TUBING WAS SAVED SO IT CANNOT BE DETERMINED IF THERE WAS AN ISSUE WITH THE PLUMSET. THERE WAS NO INJURY TO THE PT." UPON FURTHER QUERY THE FOLLOWING INFO WAS PROVIDED: THE PUMP WAS DELIVERING 25,000U/500ML OF HEPARIN AT A RATE OF 20ML/HR (1000U/HR) WITH A DOSE LIMIT OF 500ML. AFTER AN UNSPECIFIED LENGTH OF TIME, WHEN THE PT WAS TRANSPORTED BACK TO THEIR ROOM FOLLOWING AN EEG, THE NURSE CHECKED THE SETTINGS AND NOTED THAT THE HEPARIN BAG HAD APPROX. 250ML REMAINING IN THE BAG. APPROX. ONE AND HALF HOURS LATER, THE NURSE NOTED THAT THE HEPARIN BAG WAS EMPTY, THE DOOR OF THE PUMP WAS OPEN AND THAT THE TUBING CASSETTE WAS INVERTED. THE PHYSICIAN WAS NOTIFIED AND THE PT WAS "MONITORED." THERE WERE NO REPORTED ADVERSE PT EFFECTS. THE DEVICE WAS REMOVED FROM CLINICAL SERVICE. IT WAS REPORTED THAT DURING TESTING BY THE BIOMEDICAL ENGINEER AT THE USER FACILITY, THE DEVICE PASSED ALL TESTING AND WAS RETURNED TO CLINICAL SERVICE. THOUGH REQUESTED, NO ADD'L INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFECARE PLUM PUMP MODEL 5000 * FRN HOSPIRA, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 *