BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OFTPLUM A+ PUMP REFURB

    MDR report key: 4202569 · Received September 18, 2014

    Report

    Report Number
    9615050-2014-05306
    Event Type
    Malfunction
    Date Received
    September 18, 2014
    Date of Event
    September 1, 2014
    Report Date
    September 2, 2014
    Manufacturer
    HOSPIRA COSTA RICA LTD
    Product Code
    FRN
    PMA / PMN Number
    K070398
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT COMPLETE. THIS REPORT REPRESENTS ALL THE INFORMATION KNOWN BY THE REPORTER UPON QUERY BY HOSPIRA PERSONNEL.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED THAT THERE WAS A BURNING SMELL NOTED FROM THE DEVICE. THE DEVICE WAS RETURNED TO THE BIOMEDICAL DEPARTMENT FOR AN UNSPECIFIED REASON. IT WAS REPORTED THAT THE ENGINEERING DEPARTMENT NOTED A BURNING SMELL. NO SPECIFIC EVENT DETAILS WERE AVAILABLE. THERE WERE NO REPORT OF ANY ADVERSE PT EVENTS AND NO REPORTED DELAYS OF 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
    580094 OFTPLUM A+ PUMP REFURB 80FRN FRN HOSPIRA COSTA RICA LTD NA NA

    Patients

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