BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLUM A+ DRIVER NEW 8

    MDR report key: 3963325 · Received June 19, 2014

    Report

    Report Number
    9615050-2014-04088
    Event Type
    Malfunction
    Date Received
    June 19, 2014
    Date of Event
    May 29, 2014
    Report Date
    May 29, 2014
    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
    SC, 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.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED THE DEVICE INTERMITTENTLY ALARMED WITH AN E321 (BATTERY CHARGER TIMEOUT) ERROR CODE. THE DEVICE WAS RETURNED TO THE BIOMEDICAL DEPT WITH AN UNSIGNED NOTE THAT STATED, "E321 DURING INFUSION". 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 OR DELAYS IN CRITICAL THERAPIES WHILE THE DEVICE WAS IN CLINICAL USE. DURING TESTING AT THE USER FACILITY, THE DEVICE INTERMITTENTLY ALARMED WITH AN E321 (BATTERY CHARGER TIMEOUT) ERROR CODE. THIS ERROR OCCURS WHEN THE BATTERY CANNOT BE FULLY CHARGED WITHIN 8 HOURS. NO ADD'L INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    359571 PLUM A+ DRIVER NEW 8 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)