BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYMB SET2YSITES W/FI

    MDR report key: 1944213 · Received December 6, 2010

    Report

    Report Number
    9615050-2010-00248
    Event Type
    Malfunction
    Date Received
    December 6, 2010
    Date of Event
    January 1, 2010
    Report Date
    November 10, 2010
    Manufacturer
    HOSPIRA COSTA RICA LTD.
    Product Code
    FRN
    PMA / PMN Number
    K041550
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT COMPLETE. THIS REPORT REPRESENTS ALL THE INFORMATION KNOWN BY THE REPORTER UPON QUERY BY HOSPIRA PERSONNEL. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED A DELAY IN CRITICAL THERAPY FOLLOWING A LEAK. THE TUBING SET WAS BEING USED TO DELIVER AN UNSPECIFIED CONCENTRATION OF AMIODARONE. AFTER AN UNSPECIFIED LENGTH OF TIME IN USE, IT WAS REPORTED THAT THE TUBING SET LEAKED, "FROM AN UNSPECIFIED LOCATION ON THE CASSETTE AND THE TUBING SET WOULD NOT PUMP." THE TUBING SET WAS REPLACED AND THE THERAPY WAS RESUMED. ALTHOUGH THERE WAS THE POTENTIAL FOR SERIOUS INJURY, THERE WAS NO REPORTED ADVERSE PATIENT EFFECT. NO MEDICAL INTERVENTIONS WERE REPORTED. THOUGH REQUESTED, THE CUSTOMER DECLINED TO PROVIDE ANY ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYMB SET2YSITES W/FI 80FRN FRN HOSPIRA COSTA RICA LTD. NA UNK5H

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK