BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    L.C. 5000/CE 2-CHANNEL PUMP (50/CASE)

    MDR report key: 3369314 · Received August 22, 2013

    Report

    Report Number
    9615050-2013-02520
    Event Type
    Malfunction
    Date Received
    August 22, 2013
    Date of Event
    July 28, 2013
    Report Date
    July 29, 2013
    Manufacturer
    HOSPIRA COSTA RICA LTD.
    Product Code
    FPA
    PMA / PMN Number
    UNK
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOT NUMBER OF THE DEVICE THAT WAS IN USE IS UNK. THE CUSTOMER CONTACT IDENTIFIED A POSSIBLE LOT NUMBER (PLOTS). THE POSSIBLE LOT NUMBER IS 131155H. THE DEVICE IS EXPECTED TO BE RETURNED FOR INVESTIGATION. IT HAS NOT YET BEEN RECEIVED. THE CATALOG NUMBER PROVIDED IS THE INTERNATIONAL LIST NUMBER THAT WAS INVOLVED IN THE REPORTED EVENT, WHICH IS COMPARABLE TO THE DOMESTIC LIST NUMBER LISTED IN THE "OTHER" FIELD. THE DOMESTIC LIST NUMBER HAS A COMMON DEVICE NAME OF 80FRN AND HAS A 510K OF K981259. THIS REPORT REPRESENTS ALL THE INFO KNOWN BY THE REPORTER UPON QUERY BY HOSPIRA PERSONNEL.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED A CRACK IN THE SOLUSET; SUBSEQUENTLY, A LEAK WAS NOTED. THE TUBING SET WAS BEING USED TO DELIVER AN UNSPECIFIED VOLUME OF TPN (TOTAL PARENTERAL NUTRITION), AT A RATE OF 11.7 ML/HR, VIA A PLUM PUMP. AT 0030, IT WAS REPORTED THAT THE DELIVERY WAS STARTED. THE CUSTOMER CONTACT REPORTED THAT AFTER THE DELIVERY OF THE SOLUTION IN THE SOLUSET OF THE TUBING SET WAS COMPLETE, THE NURSE SQUEEZED AND REFILLED THE SOLUSET THAT WAS DELIVERED TO THE PT. AT 1100, AFTER 122ML OF TPN WAS DELIVERED, IT WAS REPORTED THAT THE PUMP ALARMED FOR AN UNSPECIFIED ALARM. AT THIS TIME, THE NURSE CHECKED THE SOLUTION CONTAINER AND NOTED THE SOLUSET OF THE TUBING SET HAD COLLAPSED INWARD. DURING REFILLING OF THE SOLUSET WITH SOLUTION AFTER THE SOLUTION WAS SQUEEZED, THE SOLUSET CRACKED AND AN UNSPECIFIED VOLUME OF SOLUTION LEAKED ONTO THE FLOOR. THE TUBING SET WAS REPLACED; HOWEVER, THE SOLUTION CONTAINER WAS REPLACED WITH A CONTAINER OF SOLUTION 18 AND DEXTROSE 10%, AND THE DELIVERY WAS RESUMED. AFTER APPROX 6 HOURS, IT WAS REPORTED THAT A NEW TPN SOLUTION CONTAINER WAS OBTAINED AND TPN THERAPY WAS RESUMED. THE CUSTOMER CONTACT REPORTED A DELAY OF THERAPY TO OBTAIN A NEW SOLUTION CONTAINER; HOWEVER, THERE WERE NO REPORTED ADVERSE PT EFFECTS. NO MEDICAL INTERVENTIONS WERE REPORTED. THOUGH REQUESTED, NO ADD'L INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    408563 L.C. 5000/CE 2-CHANNEL PUMP (50/CASE) UNK FPA HOSPIRA COSTA RICA LTD. NA PLOTS5H

    Patients

    Seq Age Sex Outcome Treatment
    1 7 DA