BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLM A+PMP W/BSE MOD

    MDR report key: 3111655 · Received May 7, 2013

    Report

    Report Number
    9615050-2013-01054
    Event Type
    Malfunction
    Date Received
    May 7, 2013
    Date of Event
    March 1, 2013
    Report Date
    April 11, 2013
    Manufacturer
    HOSPIRA COSTA RICA LTD.
    Product Code
    FRN
    PMA / PMN Number
    K011442
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TESTING AND INVESTIGATION FOUND THAT DURING TESTING, THE DEVICE DID NOT ALARM WITH AN E321 ERROR CODE; HOWEVER, THE BATTERY WAS FOUND TO NOT HOLD A CHARGE. THE DEVICE HISTORY WAS DOWNLOADED AT THE SERVICE CENTER. A REVIEW OF THE DEVICE HISTORY DID NOT FIND ANY E321 ERROR CODES AS REPORTED BY THE CUSTOMER CONTACT. AS INDICATED, THE DEVICE HAS BEEN IDENTIFIED AS 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

    THE CUSTOMER CONTACT REPORTED THE DEVICE ALARMED WITH AN E321 (BATT CHARGER TIMEOUT) ERROR CODE. THE DEVICE WAS RETURNED TO THE BIOMEDICAL DEPARTMENT WITH A NOTE THAT STATED, "DEPLETED BATTERY." THERE WERE NO REPORTS OF ANY ADVERSE PATIENT EVENTS OR DELAYS IN CRITICAL THERAPIES WHILE THE PUMP WAS IN CLINICAL USE. DURING TESTING AT THE USER FACILITY, THE DEVICE ALARMED WITH AN E321 (BATT CHARGER TIMEOUT) ERROR CODE. THOUGH REQUESTED, NO ADDITIONAL INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    199817 PLM A+PMP W/BSE MOD 80FRN FRN HOSPIRA COSTA RICA LTD. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA PLUM A+ SOFTWARE MODULE, LIST #12097, SN (B)(4)