BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLUM A + DRIVER NEW

    MDR report key: 3832196 · Received March 7, 2014

    Report

    Report Number
    9615050-2014-01743
    Event Type
    Malfunction
    Date Received
    March 7, 2014
    Date of Event
    February 9, 2014
    Report Date
    February 11, 2014
    Manufacturer
    HOSPIRA COSTA RICA LTD.
    Product Code
    FRN
    PMA / PMN Number
    K042081
    Removal / Correction Number
    FA210-07
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A FIELD SERVICE ENGINEER PERFORMED TESTING AND INVESTIGATION AT THE USER FACILITY. DURING TESTING, THE DEVICE PASSED TESTING. AN E321 (BATTERY CHARGER TIMEOUT) ERROR CODE WAS NOTED IN THE DEVICE HISTORY BUT WAS NOT DUPLICATED DURING TESTING. ALTHOUGH THE DEVICE PASSED TESTING, THE DEVICE HAS BEEN IDENTIFIED A PART OF A PRODUCT RECALL. THIS REPORT REPRESENTS ALL THE INFO KNOWN BY THE REPORTER UPON QUERY BY HOSPIRA PERSONNEL.

    Description of Event or Problem · 1

    DURING TESTING AT THE USER FACILITY, AN E321 (BATTERY CHARGER TIMEOUT) ERROR CODE WAS NOTED. THE DEVICE WAS RETURNED TO THE BIOMEDICAL DEPARTMENT FOR A REPORT OF STOPPED WORKING ERROR CODE. NO TRACKING INFO WAS PROVIDED; THEREFORE, SPECIFIC PATIENT INFO, PUMP PROGRAMMING, OR EVENT DETAILS WERE NOT AVAILABLE. THERE WERE NO REPORTS OF ANY ADVERSE PATIENT EVENTS OR DELAYS IN CRITICAL THERAPIES WHILE THE DEVICE WAS IN CLINICAL USE. NO ADD'L INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    138537 PLUM A + DRIVER NEW 80FRN FRN HOSPIRA COSTA RICA LTD. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK PLUM A+ SOFTWARE MODULE, LIST #20791, SN UNK