BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLUM A+3 PUMP

    MDR report key: 1011817 · Received March 11, 2008

    Report

    Report Number
    2921482-2008-00080
    Event Type
    Malfunction
    Date Received
    March 11, 2008
    Date of Event
    February 13, 2008
    Report Date
    February 14, 2008
    Manufacturer
    HOSPIRA, INC.
    Product Code
    FRN
    PMA / PMN Number
    K024084
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TESTING AND INVESTIGATION FOUND THE DEVICE DID NOT SOUND AN AUDIBLE ALARM TONE DURING AN ALARM CONDITION. THIS WAS DUE THE PIEZO ALARM ASSEMBLY CONNECTOR WAS NOT PLUGGED INTO THE CENTRAL PROCESSING UNIT CIRCUIT BOARD.

    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 THE REPORT OF AN ALARM CONDITION. DURING TESTING AT THE USER FACILITY, THE PUMP DID NOT SOUND AN AUDIBLE ALARM TONE DURING AN ALARM CONDITION. THERE WERE NO REPORTS OF ANY ADVERSE PT EVENTS 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 A+3 PUMP 80-FRN FRN HOSPIRA, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA