BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLUM A+ PUMP REFURB

    MDR report key: 4060302 · Received August 8, 2014

    Report

    Report Number
    9615050-2014-04722
    Event Type
    Malfunction
    Date Received
    August 8, 2014
    Date of Event
    July 1, 2014
    Report Date
    July 21, 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 REC'D. INVESTIGATION IS NOT COMPLETE. 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 THAT DURING TESTING AT THE USER FACILITY, IT WAS FOUND THE "PUMP FAILED ALARMING THE 'PROXIMAL AIR IN LINE' SEVERAL TIMES, EVEN WITH NEW, PRIMED SET. ALSO THE FLOW RATE NEEDS CALIBRATING (130ML/HR WHEN SET AT 125 ML/HR)". THERE WERE NO REPORTS OF ANY ADVERSE PATIENT EVENTS OR DELAYS IN CRITICAL THERAPIES WHILE THE DEVICE WAS IN CLINICAL USE. NO ADD'L INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    472958 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)