BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NV FIL SOLUSET 100

    MDR report key: 2430837 · Received December 27, 2011

    Report

    Report Number
    9615050-2011-00990
    Event Type
    Malfunction
    Date Received
    December 27, 2011
    Date of Event
    November 25, 2011
    Report Date
    November 30, 2011
    Manufacturer
    HOSPIRA COSTA RICA
    Product Code
    FPA
    PMA / PMN Number
    UNK
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT COMPLETE. THE CATALOG NUMBER PROVIDED IS THE INTERNATIONAL LIST NUMBER THAT WAS INVOLVED IN THE REPORTED EVENT, WHICH IS COMPARABLE TO THE DOMESTIC LIST NUMBER LISTED IN THE "OTHER" FIELD. THE DOMESTIC LIST NUMBER HAS A COMMON DEVICE NAME OF (B)(4) AND HAS A 510K OF K063239. THIS REPORT REPRESENTS ALL THE INFORMATION KNOWN BY THE REPORTER UPON QUERY BY HOSPIRA PERSONNEL.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED A SEPARATION. THE TUBING SET WAS BEING USED TO DELIVER AN UNSPECIFIED VOLUME OF 0.9 PERCENT NORMAL SALINE VIA GRAVITY. AFTER AN UNSPECIFIED LENGTH OF TIME, IT WAS REPORTED THAT THE TUBING SEPARATED FROM THE PROXIMAL LID OF THE SOLUSET. THE TUBING SET WAS REPLACED AND THE THERAPY WAS RESUMED. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS AND NO REPORTED DELAY OF THERAPY CRITICAL TO THIS PATIENT. 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 FIL SOLUSET 100 UNK FPA HOSPIRA COSTA RICA NA 021085G

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK