BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLUM A+ DRIVER ED 2

    MDR report key: 2062947 · Received March 21, 2011

    Report

    Report Number
    9615050-2011-00172
    Event Type
    Malfunction
    Date Received
    March 21, 2011
    Date of Event
    February 15, 2011
    Report Date
    February 23, 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
    CO, 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 REPORTER 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. THE PUMP WAS SENT TO THE BIOMEDICAL ENGINEERING DEPARTMENT WITH AN UNSIGNED NOTE STATING, "ERROR 31." NO TRACKING INFO WAS PROVIDED; THEREFORE, SPECIFIC PT INFO, PUMP PROGRAMMING, OR EVENT DETAILS WERE NOT AVAILABLE. DURING TESTING AT THE USER FACILITY, THE DEVICE DISPLAYED E301 (AUDIO ALARM FAILURE) WITH NO AUDIBLE ALARM TONE. 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 A+ DRIVER ED 2 80FRN FRN HOSPIRA COSTA RICA LTD. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK PLUM A+ SOFTWARE MODULE| LIST# 20791, SN (B)(4)