BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NV PRM 1 LWR CLV 100"

    MDR report key: 1237456 · Received November 11, 2008

    Report

    Report Number
    9613251-2008-00378
    Event Type
    Malfunction
    Date Received
    November 11, 2008
    Date of Event
    October 1, 2008
    Report Date
    October 29, 2008
    Manufacturer
    HOSPIRA, LTD.
    Product Code
    FPA
    PMA / PMN Number
    K941214
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    MEDICAL ASSISTANT

    Narratives

    Additional Manufacturer Narrative · 1

    DUE TO HAZARDOUS CONTAMINATION, THE DEVICES WILL NOT BE RETURNED FOR INVESTIGATION. THIS REPORT REPRESENTS ALL THE INFORMATION KNOWN BY THE REPORTER UPON QUERY BY HOSPIRA PERSONNEL.

    Description of Event or Problem · 1

    GENERAL REPORT RECEIVED OF AN UNSPECIFIED NUMBER OF UNDOCUMENTED INCIDENTS OF DIFFICULTY REGULATING FLOW; SUBSEQUENTLY, THE PATIENTS RECEIVED MORE SOLUTIONS THAN INTENDED. THE TUBING SETS WERE BEING USED TO DELIVER UNSPECIFIED CHEMOTHERAPEUTIC SOLUTIONS. THE CLAIR CLAMPS WERE BEING USED TO REGULATE THE FLOW. AFTER UNSPECIFIED LENGTHS OF TIME IN USE, IT WAS REPORTED "THE ROLLER CLAMPS APPEAR TO HAVE STAYED IN PLACE, BUT THE RATES SPONTANEOUSLY CHANGE TO A FASTER DELIVERY." THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS. NO MEDICAL INTERVENTIONS WERE REQUIRED. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NV PRM 1 LWR CLV 100" 80-FPA FPA HOSPIRA, LTD. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1