BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLUM A+ 3 MEDNET SW

    MDR report key: 2043215 · Received February 24, 2011

    Report

    Report Number
    9615050-2011-00110
    Event Type
    Malfunction
    Date Received
    February 24, 2011
    Date of Event
    January 19, 2011
    Report Date
    January 28, 2011
    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
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AT THIS TIME, THE CUSTOMER WILL NOT BE RETURNING THE DEVICE FOR EVAL. IF THE DEVICE IS RECEIVED, A F/U REPORT WILL BE SUBMITTED. THE DEVICE WAS NOT RETURNED TO HOSPIRA FOR TESTING AND INVESTIGATION; THEREFORE, ATTRIBUTION OF THE ISSUE TO THE DEVICE COULD NOT BE DETERMINED. THE PUMP HISTORY WAS DOWNLOADED AT THE USER FACILITY. A REVIEW OF THE PUMP HISTORY FOUND THERE IS NO PUMP PROGRAMMING THAT CORRELATES WITH REPORTED EVENT; THEREFORE, THE HISTORY CANNOT BE UTILIZED TO EVALUATE THE REPORTED EVENT. 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 PT RECEIVED MORE MEDICATION THAN INTENDED. AT APPROX 2100, LINE A OF CHANNEL 3 WAS PROGRAMMED TO DELIVER MAGNESIUM SULFATE 2GM/50ML, AT A RATE OF 50ML/HR, WITH A VTBI (VOLUME TO BE INFUSED) OF 50ML, AND THE DELIVERY WAS STARTED. AFTER UNSPECIFIED LENGTH OF TIME "BEFORE THE REQUIRED HOUR," THE NURSE NOTED, THE DELIVERY WAS COMPLETE. THE PT COMPLAINED OF "FEELING FLUSHED." THE PUMP WAS REMOVED FROM CLINICAL SVC. THERAPY WAS RESUMED USING A REPLACEMENT PUMP. THOUGH REQUESTED, NO ADDITIONAL INFO WAS PROVIDED, INCLUDING WHAT IF MEDICAL INTERVENTIONS WERE REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PLUM A+ 3 MEDNET SW 80FRN FRN HOSPIRA COSTA RICA LTD. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK