BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NV100IN PRM PG MACRO

    MDR report key: 1880989 · Received October 5, 2010

    Report

    Report Number
    9613251-2010-00128
    Event Type
    Malfunction
    Date Received
    October 5, 2010
    Date of Event
    May 28, 2010
    Report Date
    September 11, 2010
    Manufacturer
    HOSPIRA LTD.
    Product Code
    FPA
    PMA / PMN Number
    K030002
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    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. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED A SEPARATION. THE TUBING SET WAS TO BE USED TO DELIVER AN UNSPECIFIED SOLUTION. IT WAS REPORTED THAT DURING PRIMING OF THE TUBING SET PRIOR TO PATIENT USE, THE CUSTOMER CONTACT REPORTED THAT A ¿PIECE OF TUBING FELL OFF DURING PRIMING.¿ THERE WAS NO REPORTED DELAY IN CRITICAL THERAPY. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NV100IN PRM PG MACRO 80FPA FPA HOSPIRA LTD. NA 810544W

    Patients

    Seq Age Sex Outcome Treatment
    1 NA