BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLUM A+3 PUMP MEDNET WIRELESS

    MDR report key: 1193464 · Received October 7, 2008

    Report

    Report Number
    2921482-2008-00317
    Event Type
    Malfunction
    Date Received
    October 7, 2008
    Date of Event
    September 15, 2008
    Report Date
    September 15, 2008
    Manufacturer
    HOSPIRA, INC.
    Product Code
    FRN
    PMA / PMN Number
    K052052
    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 WAS RECEIVED. INVESTIGATION IS NOT COMPLETE.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED THAT THE PUMP DID NOT SOUND AN AUDIBLE ALARM TONE DURING AN ALARM CONDITION. THE PUMP WAS RETURNED TO THE BIOMEDICAL ENGINEERING DEPT WITH AN UNSIGNED NOTE INDICATING THE PUMP WAS "MALFUNCTIONING." NO TRACKING INFO WAS PROVIDED; THEREFORE, SPECIFIC PT INFO, PUMP PROGRAMMING, OR EVENT DETAILS WERE NOT AVAILABLE. THERE WERE NO REPORTS OF ANY ADVERSE PT EVENTS WHILE THE DEVICE WAS IN CLINICAL USE. DURING TESTING AT THE USER FACILITY, THE CHANNEL 3 OF THE PUMP DID NOT SOUND AN AUDIBLE ALARM TONE DURING AN ALARM CONDITION. THOUGH REQUESTED, NO ADD'L INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PLUM A+3 PUMP MEDNET WIRELESS 80-FRN FRN HOSPIRA, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK