BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLUM A + DRIVER NEW

    MDR report key: 3912660 · Received May 14, 2014

    Report

    Report Number
    9615050-2014-03409
    Event Type
    Malfunction
    Date Received
    May 14, 2014
    Date of Event
    April 17, 2014
    Report Date
    April 25, 2014
    Manufacturer
    HOSPIRA COSTA RICA LTD.
    Product Code
    FRN
    PMA / PMN Number
    K042801
    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 NOT NOTED IN THE DEVICE HISTORY BUT WAS NOT DUPLICATED DURING TESTING. ALTHOUGH THE DEVICE PASSED TESTING, THE DEVICE HAS BEEN IDENTIFIED AS PART OF A PRODUCT RECALL. THIS REPORT REPRESENTS ALL THE INFORMATION 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. THIS ERROR OCCURS WHEN THE BATTERY CANNOT BE FULLY CHARGED WITHIN 8 HRS. THE DEVICE WAS RETURNED TO THE BIOMED DEPT FOR A REPORT OF MALFUNCTION. NO TRACKING INFORMATION WAS PROVIDED; THEREFORE, SPECIFIC PATIENT INFORMATION, 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 ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    288261 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 #UNK, SN UNK