BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLUM XL PLS MIC/MAC

    MDR report key: 1812450 · Received August 17, 2010

    Report

    Report Number
    2921482-2010-00630
    Event Type
    Malfunction
    Date Received
    August 17, 2010
    Date of Event
    July 1, 2010
    Report Date
    July 20, 2010
    Manufacturer
    HOSPIRA, INC.
    Product Code
    FRN
    PMA / PMN Number
    K952799
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    A FIELD SERVICE ENGINEER PERFORMED TESTING AND INVESTIGATION AT THE USER FACILITY. DURING TESTING, THE CONTROL KNOB POSITION DID NOT MATCH THE DISPLAYED POSITION. THIS WAS DUE TO A WORN MAGNET. THE DEVICE SELECTS PROGRAMMING POSITIONS BY MOVING A MAGNET OVER HALL EFFECT SENSORS ON THE DISPLAY PRINTED WIRING ASSEMBLY. THE CONTROL KNOB MAGNET TURNS ON THE APPROPRIATE SENSOR, ENABLING A PROGRAMMING POSITION. WHEN THE CONTROL KNOB ASSEMBLY IS TURNED, THE CONTROL KNOB MAGNET IS TURNED ALSO TURNING ON A SENSOR. IF THE CONTROL KNOB MAGNET IS WORN OUT OR DAMAGED, THE SENSOR IN THE CONTROL KNOB POSITION MAY NOT BE TURNED ON. THIS REPORT REPRESENTS ALL THE INFO KNOWN BY THE RPTR UPON QUERY BY HOSPIRA PERSONNEL. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED THE CONTROL KNOB POSITION DID NOT MATCH THE DISPLAYED POSITION. THE DEVICE WAS RETURNED TO THE BIOMEDICAL ENGINEERING DEPT WITH AN UNSIGNED NOTE THAT STATED, "DISPLAY DOES NOT MATCH CONTROL KNOB SETTINGS." NO TRACKING INFO WAS PROVIDED; THEREFORE, SPECIFIC PT INFO, PUMP PROGRAMMING, OR EVENT DETAILS WERE NOT AVAILABLE. DURING TESTING AT THE USER FACILITY, WHEN THE CONTROL KNOB WAS TURNED TO THE SET RATE POSITION, THE DEVICE DISPLAYED SET RATE. WHEN THE CONTROL KNOB WAS SET TO THE SET VTBI POSITION, THE DEVICE DISPLAYED SET VTBI; HOWEVER, WHEN THE CONTROL KNOB WAS TURNED TO THE RESET POSITION, THE DEVICE BEEPED 3 TIMES AND CLEARED THE VOLUME INFUSED AS IF THE CONTROL KNOB WAS TURNED TO THE CLEAR VOLUME POSITION. THERE WERE NO REPORTS OF ANY ADVERSE PT EVENTS AND NO REPORTED DELAYS OF CRITICAL THERAPIES WHILE THE DEVICE WAS IN CLINICAL USE. THOUGH REQUESTED, NO ADD'L INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PLUM XL PLS MIC/MAC 80FRN FRN HOSPIRA, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK