BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLMA DVD V11.51 1 N

    MDR report key: 1781151 · Received July 29, 2010

    Report

    Report Number
    2921482-2010-00572
    Event Type
    Malfunction
    Date Received
    July 29, 2010
    Date of Event
    June 28, 2010
    Report Date
    July 2, 2010
    Manufacturer
    HOSPIRA, INC.
    Product Code
    FRN
    PMA / PMN Number
    K070398
    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. THE PUMP HISTORY WAS DOWNLOADED AT THE USER FACILITY. A REVIEW OF THE PUMP HISTORY INDICATES THAT ON (B)(6) 2010 AT 1339, LIEN A WAS PROGRAMMED TO DELIVER TPN AT A RATE OF 13ML/HR INSTEAD OF THE REPORTED RATE OF 1.3ML/HR, WITH A VTBI (VOLUME TO BE INFUSED) OF 156ML FOR A DURATION OF 12 HOURS AND THE DELIVERY WAS STARTED. AT 1700, THE DEVICE ALARMED N232 PROX AIR A. AT 1702, THE DEVICE ALARMED WITH N102 INFUSER IDLE 2 MINUTES. AT 1703, THE DEVICE ALARMED N251 CASSETTE TEST FAILURE. AT 1704, THE ALARM WAS SILENCED AND THE DEVICE WAS TURNED OFF. A REVIEW OF THE PUMP HISTORY INDICATED THE PUMP DELIVERED AS PROGRAMMED. THIS REPORT REPRESENTS ALL THE INFORMATION KNOWN BY THE REPORTER UPON QUERY BY HOSPIRA PERSONNEL. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED THE PATIENT RECEIVING MORE IV FLUID THAN INTENDED. AT AN UNSPECIFIED TIME, THE PUMP WAS PROGRAMMED TO DELIVER TPN (TOTAL PARENTERAL NUTRITION) THERAPY WITH A RATE OF 1.3ML/HR AND THE DELIVERY WAS STARTED. NO FURTHER PROGRAMMING PARAMETERS WERE PROVIDED. AFTER AN UNSPECIFIED LENGTH OF TIME, THE CLINICIAN NOTED THE PUMP DISPLAYED A RATE OF 13ML/HR. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS OR DELAY IN THERAPY CRITICAL TO THIS PATIENT. NO MEDICAL INTERVENTIONS WERE REQUIRED. THE PUMP WAS REMOVED FROM CLINICAL SERVICE. THERAPY WAS RESUMED USING A REPLACEMENT DEVICE. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED. HOSPIRA IS CONTINUING TO INVESTIGATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PLMA DVD V11.51 1 N 80FRN FRN HOSPIRA, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 (B)(4)| LIST #12097| PLUM A+ SOFTWARE MODULE