BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLUM XL PLS MIC/MAC

    MDR report key: 1931793 · Received November 22, 2010

    Report

    Report Number
    2921482-2010-00927
    Event Type
    Malfunction
    Date Received
    November 22, 2010
    Date of Event
    November 1, 2010
    Report Date
    November 1, 2010
    Manufacturer
    HOSPIRA, INC.
    Product Code
    FRN
    PMA / PMN Number
    K952799
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS EXPECTED TO BE RETURNED FOR INVESTIGATION. IT HAS NOT YET BEEN RECEIVED. 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 THAT THE PUMP DID NOT SOUND AN AUDIBLE ALARM TONE DURING AN ALARM CONDITION WHILE IN THE LOW VOLUME SETTING. THE PUMP WAS RETURNED TO THE BIOMEDICAL ENGINEERING DEPARTMENT FOR AN UNSPECIFIED REASON. NO TRACKING INFO WAS PROVIDED; THEREFORE SPECIFIC PT INFO, PUMP PROGRAMMING, OR EVENT DETAILS WERE NOT AVAILABLE. DURING TESTING AT THE USER FACILITY, THE PUMP DID NOT SOUND AN AUDIBLE ALARM TONE DURING AN ALARM CONDITION WHILE ON THE LOW VOLUME SETTING. THERE WERE NO REPORTS OF ANY ADVERSE PT EVENTS AND NO REPORTED DELAYS OF CRITICAL THERAPIES WHILE THE PUMP WAS IN CLINICAL USE. THOUGH REQUESTED, NO ADDITIONAL INFO WAS PROVIDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK