BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLUM A+ DRIVER ED 2

    MDR report key: 3410323 · Received September 6, 2013

    Report

    Report Number
    9615050-2013-02806
    Event Type
    Malfunction
    Date Received
    September 6, 2013
    Date of Event
    July 14, 2013
    Report Date
    August 7, 2013
    Manufacturer
    HOSPIRA COSTA RICA LTD.
    Product Code
    FRN
    PMA / PMN Number
    K042081
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ND, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT COMPLETE. THE DEVICE HISTORY WAS DOWNLOADED AT THE USER FACILITY. A REVIEW OF THE DEVICE HISTORY INDICATES ON (B)(6) 2013 AT 1807, LINE A WAS PROGRAMMED FOR SIMPLE DELIVERY TO DELIVER AT A RATE OF 125ML/HR, WITH A VTBI (VOLUME TO BE INFUSED) OF 600ML, FOR A DURATION OF 4 HOURS AND 48 MINUTES, AND THE DELIVERY WAS STARTED. BETWEEN 1809 AND 1828, THE DEVICE ALARMED N101 (NO ACTION ALARM) 5 TIMES AND THE ALARM WAS SILENCED 5 TIMES. AT 1845, LINE A WAS PROGRAMMED TO DELIVER IV FLUIDS (MAINTENANCE), AT A RATE OF 125ML/HR, WITH A VTBI OF 850ML, FOR A DURATION OF 6 HOURS AND 48 MINUTES, AND THE DELIVERY WAS STARTED. BETWEEN 1852 AND 1853, THE DELIVERY WAS STOPPED WITH A VOLUME INFUSED (VI) OF 211.2ML AND THE DEVICE WAS TURNED OFF. A REVIEW OF THE HISTORY INDICATES THE DEVICE DELIVERED AS PROGRAMMED. 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 THE DEVICE WAS FOUND DELIVERING AT A RATE DIFFERENT THAN THE ORIGINALLY PROGRAMMED RATE. AT AN UNSPECIFIED TIME, IT WAS REPORTED THAT THE DEVICE WAS PROGRAMMED TO DELIVER AN UNSPECIFIED VOLUME OF AN UNSPECIFIED IV FLUID, AT A RATE OF 100ML/HR AND THE DELIVERY WAS STARTED. NO FURTHER PROGRAMMING PARAMETERS WERE PROVIDED. AFTER AN UNSPECIFIED LENGTH OF TIME, THE NURSE NOTED THAT THE DEVICE HAD ZEROED OUT. NO SPECIFIC DETAILS WERE PROVIDED. THE NURSE REPORTED THAT THE DISPLAY INDICATED THAT 250ML WAS LEFT TO BE INFUSE; HOWEVER, 800ML WAS REMAINING IN THE SOLUTION CONTAINER. THE DEVICE WAS REMOVED FROM CLINICAL SERVICE. THERAPY WAS RESUMED USING A REPLACEMENT DEVICE. THERE WERE NO REPORTED ADVERSE PT EFFECTS AND NO REPORTED DELAY OF THERAPY CRITICAL TO THIS PT. NO MEDICAL INTERVENTIONS WERE REQUIRED. DURING TESTING AT THE FACILITY, THE DEVICE PASSED TESTING. THOUGH REQUESTED, NO ADDITIONAL INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    444997 PLUM A+ DRIVER ED 2 80FRN FRN HOSPIRA COSTA RICA LTD. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK PLUM A+ SOFTWARE MODULE, LIST # 20791,| SN (B)(4)