BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLUM A+ DRIVER EDITION 2

    MDR report key: 6050535 · Received October 24, 2016

    Report

    Report Number
    9615050-2016-00058
    Event Type
    Malfunction
    Date Received
    October 24, 2016
    Date of Event
    January 1, 2016
    Report Date
    September 13, 2016
    Manufacturer
    HOSPIRA COSTA RICA LTD.
    Product Code
    FRN
    PMA / PMN Number
    K042081
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE DEVICE WAS RETURNED TO THE SERVICE CENTER WITH A CUSTOMER REPORT OF THE DEVICE CONTINUOUSLY REBOOTING ON ITS OWN. THIS DOES NOT INDICATE A REPORTABLE EVENT. HOWEVER, DURING TESTING AT THE SERVICE CENTER THE UNIT AUDIBLY ALARMED WITH E302 (BACKLIGHT FAILURE). AN ABNORMAL BURN WAS FOUND ON THE DRIVER PRINTED WIRE ASSEMBLY (PWA) AND FLAT CABLE FROM DRIVER PWA TO AIR, PRESSURE AND PIN PRINTED WIRE ASSEMBLY (APP PWA). NO PROBABLE CAUSE WAS FOUND FOR THE COMPLAINT OF THE DEVICE CONTINUOUSLY REBOOTING ON IT OWN, AS IT WAS NOT DUPLICATED DURING TESTING AND THE MECHANISM PASSED FUNCTIONAL TESTING WITHIN SPECIFICATIONS. THE PROBABLY CAUSE FOR THE E302 ALARM WAS DUE TO THE BURN ON THE DRIVER PWA AND FLAT CABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    703595 PLUM A+ DRIVER EDITION 2 PUMP INFUSION FRN HOSPIRA COSTA RICA LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1