BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOLUSET 100X60W/CAI

    MDR report key: 3621823 · Received December 17, 2013

    Report

    Report Number
    9615050-2013-06036
    Event Type
    Malfunction
    Date Received
    December 17, 2013
    Date of Event
    November 1, 2013
    Report Date
    November 21, 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. INVESTIGATION IS NOT COMPLETE. THE CATALOG NUMBER PROVIDED IS THE INTERNATIONAL LIST NUMBER THAT WAS INVOLVED IN THE REPORTED EVENT, WHICH IS COMPARABLE TO THE DOMESTIC LIST NUMBER LISTED IN THE "OTHER" FIELD. THE DOMESTIC LIST NUMBER HAS A COMMON DEVICE NAME OF (B)(4) AND HAS A 510K OF K101677. THE INTERNATIONAL AFFILIATE WAS CONTACTED AND INFORMATION ON REPROCESSING OF THE DEVICE WAS REQUESTED. NO RESPONSE HAS BEEN RECEIVED. THIS REPORT REPRESENTS ALL THE INFORMATION KNOWN BY THE REPORTER UPON QUERY BY HOSPIRA PERSONNEL.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED A MISSING COMPONENT. ON AN UNSPECIFIED DATE, IT WAS REPORTED THAT THERE WAS NO CONTROL VALVE. NO SPECIFIC DETAILS WERE PROVIDED. NO INFORMATION WAS PROVIDED IF THE MISSING COMPONENT WAS NOTED DURING OR PRIOR TO PATIENT USE; HOWEVER, THE CUSTOMER CONTACT INDICATED THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS AND NO REPORTED DELAY OF THERAPY. NO MEDICAL INTERVENTIONS WERE REPORTED. MULTIPLE UNSUCCESSFUL ATTEMPTS HAVE BEEN MADE TO OBTAIN ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    659909 SOLUSET 100X60W/CAI UNK FRN HOSPIRA COSTA RICA LTD. NA 170835G

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK