BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLUM A+ 11.6 POLAND

    MDR report key: 1933770 · Received December 20, 2010

    Report

    Report Number
    2921482-2010-00948
    Event Type
    Malfunction
    Date Received
    December 20, 2010
    Date of Event
    October 22, 2010
    Report Date
    November 4, 2010
    Manufacturer
    HOSPIRA, INC.
    Product Code
    FRN
    PMA / PMN Number
    K070398
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT COMPLETE. THIS REPORT REPRESENTS ALL THE INFO KNOWN BY THE REPORTER UPON QUERY BY HOSPIRA PERSONNEL. (B)(4)

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED AN UNSPECIFIED NUMBER OF UNDOCUMENTED INCIDENTS WHERE AIR WAS NOTED IN THE TUBING DISTAL TO THE PUMP WITH NO PUMP ALARM WHILE THE PUMP WAS IN USE. THE CUSTOMER REPORTED THAT WHEN THE PUMP WAS PROGRAMMED TO DELIVER AT RATES LESS THAN OR EQUAL TO 5ML/HR, AN UNSPECIFIED AMOUNT AND UNSPECIFIED SIZE OF AIR BUBBLES WERE NOTED IN THE TUBING DISTAL TO THE PUMP WITH NO PUMP ALARM. THERE WERE NO REPORTS OF ANY ADVERSE PT EVENTS AND NO REPORTED DELAYS OF CRITICAL THERAPIES WHILE THE PUMP WAS IN CLINICAL USE. THE AIR SENSITIVITY ON THE PLUM A+ DEVICE IS A FIXED SETTING TO RECOGNIZE AIR BUBBLES GREATER THAN OR EQUAL TO 0.5ML. HOSPIRA IS CONTINUING TO INVESTIGATE THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PLUM A+ 11.6 POLAND 80FRN FRN HOSPIRA, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 (B)(4)| PLUM A+ SOFTWARE MODULE, LIST #12097