BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLUM A+ PUMP REFURB

    MDR report key: 3802760 · Received February 21, 2014

    Report

    Report Number
    9615050-2014-01410
    Event Type
    Malfunction
    Date Received
    February 21, 2014
    Date of Event
    January 1, 2014
    Report Date
    January 22, 2014
    Manufacturer
    HOSPIRA COSTA RICA LTD.
    Product Code
    FRN
    PMA / PMN Number
    K070398
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RP
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS EXPECTED TO BE RETURNED FOR INVESTIGATION IT HAS NOT YET BEEN RECEIVED. 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 DURING TESTING AT THE USER FACILITY THE DEVICE CONTINUED TO DELIVER AT THE PROGRAMMED RATE, AFTER THE PROGRAMMED VOLUME TO BE INFUSED WAS COMPLETE. THERE WAS NO REPORTS OF ANY ADVERSE PATIENT EVENTS, AND NO REPORTED DELAYS OF CRITICAL THERAPIES WHILE THE DEVICE WAS IN CLINICAL USE. THOUGH REQUESTED, NO ADD'L INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    109000 PLUM A+ PUMP REFURB 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)