BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NVPRM PB CLV OL100IN

    MDR report key: 1882928 · Received October 15, 2010

    Report

    Report Number
    9613251-2010-00135
    Event Type
    Malfunction
    Date Received
    October 15, 2010
    Date of Event
    September 1, 2010
    Report Date
    September 17, 2010
    Manufacturer
    HOSPIRA LTD.
    Product Code
    FPA
    PMA / PMN Number
    K030002
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER INDICATED THE DEVICE WAS DISCARDED. THE DEVICE WAS NOT RETURNED TO HOSPIRA FOR TESTING AND INVESTIGATION; THEREFORE, ATTRIBUTION OF THE ISSUE TO THE DEVICE COULD NOT BE DETERMINED. THE REPORTER WAS CONTACTED AND INFORMATION ON REPROCESSING OF THE DEVICE WAS REQUESTED; HOWEVER, THE INFORMATION WAS NOT OBTAINED. 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 DIFFICULTY REGULATING FLOW. THE TUBING SET WAS BEING USED TO DELIVER AN UNSPECIFIED SOLUTION. THE CAIR CLAMP WAS BEING USED TO REGULATE THE FLOW RATE. AFTER AN UNSPECIFIED LENGTH OF TIME IN USE, THE CUSTOMER CONTACT REPORTED, "THE ROLLER CLAMP IS LOOSE" AND THE FLOW WAS DIFFICULT TO REGULATE. THE TUBING SET WAS REPLACED AND THE THERAPY WAS RESUMED. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS AND NO REPORTED DELAYS IN THERAPY CRITICAL FOR THIS PATIENT. NO MEDICAL INTERVENTIONS WERE REPORTED. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NVPRM PB CLV OL100IN 80FPA FPA HOSPIRA LTD. NA 890244W

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK