BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLUM 360 DRIVER NEW

    MDR report key: 6394741 · Received March 10, 2017

    Report

    Report Number
    9615050-2017-00036
    Event Type
    Malfunction
    Date Received
    March 10, 2017
    Date of Event
    February 10, 2017
    Report Date
    February 10, 2017
    Manufacturer
    HOSPIRA COSTA RICA LTD.
    Product Code
    FRN
    PMA / PMN Number
    K141789
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SUBSEQUENT TO THE SUBMISSION OF THE INITIAL MEDICAL DEVICE REPORT, THE CORRECT CONTACT PHONE, CONTACT ADDRESS AND CONTACT CITY WAS PROVIDED. THE CORRECTED CONTACT ADDRESS IS: (B)(6).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A DEVICE THAT WOULD NOT POWER UP ON AC OR DC POWER AND HAD AN INACTIVE AC LED INDICATOR. THIS DOES NOT INDICATE A REPORTABLE EVENT. HOWEVER, DURING TESTING, THE FIELD SERVICE ENGINEER FOUND THAT THERE WAS A BURN SMELL, AND CONFIRMED THAT THE MECHANISM WAS DAMAGED DUE TO THE BURNING CENTER OF THE DRIVER PRINTED WIRING ASSEMBLY (PWA). THE FSE REPLACED THE MECHANISM ASSEMBLY, POWER SUPPLY PWA, AND CENTRAL PROCESSING UNIT (CPU) PWA, AND THE PROBABLE CAUSE WAS DETERMINED TO BE DAMAGE TO THESE COMPONENTS.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A DEVICE THAT WOULD NOT POWER UP ON AC OR DC POWER AND HAD AN INACTIVE AC LED INDICATOR. THIS DOES NOT INDICATE A REPORTABLE EVENT. HOWEVER, DURING TESTING, THE FIELD SERVICE ENGINEER FOUND THAT THERE WAS A BURN SMELL, AND CONFIRMED THAT THE MECHANISM WAS DAMAGED DUE TO THE BURNING CENTER OF THE DRIVER PRINTED WIRING ASSEMBLY (PWA). THE FSE REPLACED THE MECHANISM ASSEMBLY, POWER SUPPLY PWA, AND CENTRAL PROCESSING UNIT (CPU) PWA, AND THE PROBABLE CAUSE WAS DETERMINED TO BE DAMAGE TO THESE COMPONENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    179566 PLUM 360 DRIVER NEW PUMP INFUSION FRN HOSPIRA COSTA RICA LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1