BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NV FIL SOLUSET 100

    MDR report key: 1775793 · Received July 22, 2010

    Report

    Report Number
    9615050-2010-00137
    Event Type
    Malfunction
    Date Received
    July 22, 2010
    Date of Event
    June 23, 2010
    Report Date
    June 25, 2010
    Manufacturer
    HOSPIRA COSTA RICA LTD.
    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 IS COMPARABLE TO THE DOMESTIC LIST NUMBER IN THE "OTHER" FIELD. THE DOMESTIC LIST NUMBER HAS A COMMON DEVICE NAME OF AN 80FPK AND HAS A 510K OF K063239. 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 THE FLOAT VALVE IN THE SOLUSET IN THE TUBING SET DID NOT CLOSE WHEN THE SOLUSET EMPTIED. IT WAS REPORTED THE SOLUSET WAS FILLED WITH AN UNSPECIFIED VOLUME OF EPILIM AND AFTER AN UNSPECIFIED LENGTH OF TIME IN USE, THE SOLUSET EMPTIED. IT WAS REPORTED THAT THE FLOAT VALVE DID NOT CLOSE WHEN THE EPILIM DELIVERY WAS COMPLETED. IT WAS NOT SPECIFIED IF AIR REACHED THE PATIENT; HOWEVER, THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS AND NO REPORTED DELAY IN 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 LTD. NA 710725G

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK