BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOLUSET 100X60 CE-SL

    MDR report key: 1456391 · Received June 18, 2009

    Report

    Report Number
    9615050-2009-00134
    Event Type
    Malfunction
    Date Received
    June 18, 2009
    Date of Event
    May 15, 2009
    Report Date
    May 22, 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
    GR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS EXPECTED TO BE RETURNED FOR INVESTIGATION. IT HAS NOT YET BEEN RECEIVED. THE CATALOG NUMBER PROVIDED IS THE INTERNATIONAL LIST NUMBER THAT WAS INVOLVED IN THE REPORTED EVENT, WHICH IS COMPARABLE TO THE DOMESTIC LIST NUMBER 12722. THE DOMESTIC LIST NUMBER HAS A COMMON DEVICE NAME OF 80FPK AND HAS A 510K OF K063239. (B) (4) (B) (4). (B) (6).

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED A PARTICULATE. THE TUBING SET WAS BEING USED TO DELIVER AN UNSPECIFIED VOLUME OF SALINE SOLUTION. AFTER AN UNSPECIFIED LENGTH OF TIME IN USE, THE NURSE NOTED A PARTICULATE AT AN UNSPECIFIED LOCATION IN THE TUBING SET. THE TUBING SET WAS REPLACED AND THE THERAPY WAS RESUMED. 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 100X60 CE-SL UNK FPA HOSPIRA COSTA RICA LTD. NA 600465G

    Patients

    Seq Age Sex Outcome Treatment
    1