BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOLUSET 100X60W/CAI

    MDR report key: 3575169 · Received December 10, 2013

    Report

    Report Number
    9615050-2013-05839
    Event Type
    Malfunction
    Date Received
    December 10, 2013
    Date of Event
    November 1, 2013
    Report Date
    November 13, 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 THAT THE DEVICE WAS DISCARDED. DURING THE INVESTIGATION, NO POSSIBLE CAUSE FOR THE CUSTOMER REPORTED LEAK WERE IDENTIFIED. THE DEVICE WAS NOT RETURNED TO HOSPIRA FOR TESTING AND INVESTIGATION; THEREFORE, ATTRIBUTION OF THE ISSUE TO THE DEVICE COULD NOT BE DETERMINED. THE CATALOG NUMBER PROVIDED IS THE INTERNATIONAL LIST NUMBER THAT WAS INVOLVED IN THE REPORTED EVENT, WHICH IS COMPARABLE TO THE DOMESTIC LIST NUMBER HAS A COMMON DEVICE NAME OF 80FPA AND HAS A 510K OF K101677. THE INFORMATION ON REPROCESSING OF THE DEVICE WAS REQUESTED; HOWEVER, NO RESPONSE HAS BEEN RECEIVED. THIS REPORT REPRESENTS ALL INFORMATION KNOWN BY THE REPORTER UPON QUERY BY HOSPIRA PERSONNEL.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED A LEAK. ON AN UNSPECIFIED DATE, IT WAS REPORTED THAT THE CAP WHICH TO ADD MEDICINE COULD NOT BE CLOSED AND AN UNSPECIFIED VOLUME OF SOLUTION LEAKED. NO SPECIFIC DETAILS WERE PROVIDED INCLUDING IF THE LEAK OCCURRED DURING A PRIOR TO PT USE; HOWEVER, THE CUSTOMER CONTACT INDICATED THERE WERE NO REPORTED ADVERSE PT EFFECTS AND NO REPORTED DELAY OF THERAPY. NO MEDICAL INTERVENTIONS WERE REPORTED. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED INCLUDING IF THE TUBING SET WAS REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    645295 SOLUSET 100X60W/CAI UNK FRN HOSPIRA COSTA RICA LTD. NA 170825G

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK