BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOLUSET 100X60W/CAI

    MDR report key: 3367456 · Received August 6, 2013

    Report

    Report Number
    9615050-2013-02293
    Event Type
    Malfunction
    Date Received
    August 6, 2013
    Date of Event
    July 9, 2013
    Report Date
    July 9, 2013
    Manufacturer
    HOSPIRA COSTA RICA LTD.
    Product Code
    FRN
    PMA / PMN Number
    UNK
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER CONTACT INDICATED THE DEVICE WAS DISCARDED. INVESTIGATION IS NOT COMPLETE. THE CATALOG NUMBER PROVIDED IS THE INTERNATIONAL LIST NUMBER THAT WAS INVOLVED IN THE REPORTED EVENT. THE COMMODITY ON THE INTERNATIONAL LIST NUMBER THAT MALFUNCTIONED IS COMPARABLE TO THE COMMODITY ON THE DOMESTIC LIST NUMBER. THE DOMESTIC LIST NUMBER HAS A COMMON DEVICE NAME OF (B)(4) AND HAS A 510K OF K101677. THIS REPORT REPRESENTS ALL THE INFO KNOWN BY THE REPORTER UPON QUERY BY HOSPIRA PERSONNEL.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED DEVICE BREAKAGE. THE TUBING SET WAS BEING USED TO DELIVER AN UNSPECIFIED MEDICATION, AT AN UNSPECIFIED RATE. AFTER AN UNSPECIFIED LENGTH OF TIME, A BREAK AT AN UNSPECIFIED END OF THE TUBING SET WAS NOTED. NO SPECIFIC DETAILS WERE PROVIDED. ALTHOUGH THERE WAS POTENTIAL FOR A LEAK, NO LEAKAGE WAS REPORTED. THERE WERE NO REPORTED ADVERSE PT EFFECTS AND NO REPORTED DELAY OF THERAPY CRITICAL TO THIS PT. NO MEDICAL INTERVENTIONS WERE REQUIRED. THOUGH REQUESTED, NO ADDITIONAL INFO WAS PROVIDED INCLUDING IF THE TUBING SET WAS REPLACED AND THE THERAPY WAS RESUMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    369410 SOLUSET 100X60W/CAI UNK FRN HOSPIRA COSTA RICA LTD. NA 152405G

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK