BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOLUSET 150 BURETTE

    MDR report key: 1396775 · Received March 12, 2009

    Report

    Report Number
    9615050-2009-00057
    Event Type
    Malfunction
    Date Received
    March 12, 2009
    Date of Event
    January 1, 2008
    Report Date
    February 18, 2009
    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
    SP
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER INDICATED THE DEVICES WERE DISCARDED. 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 80 FPK COMMON DEVICE NAME AND HAS A K063239 510K. (B) (4).

    Description of Event or Problem · 1

    GENERAL REPORT RECEIVED OF AN UNSPECIFIED NUMBER OF UNDOCUMENTED INCIDENTS OF THE FLOAT VALVES IN THE SOLUSETS DID NOT CLOSE WHEN THE SOLUSETS EMPTIED. THE SOLUSETS WERE BEING USED TO DELIVER UNSPECIFIED SOLUTIONS. IT WAS REPORTED AT THE END OF THE INFUSIONS, THE FLOAT VALVES IN THE SOLUSETS DID NOT CLOSE WHEN THE SOLUSETS EMPTIED. 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 SOLUSET 150 BURETTE UNK FPA HOSPIRA COSTA RICA LTD. NA 560245G

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK