BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AVANTA MULTI-PT DISPOSABLE SET

    MDR report key: 1610181 · Received February 4, 2010

    Report

    Report Number
    2520313-2010-00008
    Event Type
    Malfunction
    Date Received
    February 4, 2010
    Date of Event
    January 5, 2010
    Report Date
    February 4, 2010
    Manufacturer
    MEDRAD, INC.
    Product Code
    DXT
    Removal / Correction Number
    2520313-1/15/10-001-R
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THREE OF THE FOUR MPATS WERE RETURNED TO MEDRAD FOR EVALUATION. VISUAL INSPECTION OF THE MPATS FOUND THAT TWO OF THE HIGH PRESSURE CHECK VALVES WERE RESTRICTED BY MOLDING FLASH. THE HIGH PRESSURE CHECK VALVE OF THE THIRD MPAT DID NOT HAVE ANY VISIBLE FLASH. A FLOW TEST WAS PERFORMED ON THIS THIRD MPAT WITH THE RESULTING DETERMINATION THAT THE HIGH PRESSURE CHECK VALVE PERFORMED TO SPECIFICATION. THE REPORTED LOT NUMBER, 820007, IS CURRENTLY UNDER RECALL FOR THIS ISSUE (MOLDING FLASH); THEREFORE, IT IS POSSIBLE THAT THE DEVICE USED DURING THIS EVENT MAY HAVE CONTRIBUTED TO A MALFUNCTION, AS DEFINED IN 21 CFR 803.

    Description of Event or Problem · 1

    THE SITE REPORTED THAT THEY HAD ISSUES PURGING THE SALINE SIDE OF FOUR OF THE AVANTA MULTI-PT DISPOSABLE SETS (MPAT), WHICH WERE ALL FROM THE SAME LOT NUMBER, 820007. THEY REPORTED THAT THE FLOW FROM THE SALINE SIDE OF THE MPAT WAS INSUFFICIENT TO PROPERLY PURGE THE SALINE LINE OF AIR. DURING THE MPAT PURGE, THE AVANTA FLUID MANAGEMENT INJECTION SYSTEM SOUNDED NORMAL BUT THE FLOW FROM THE SALINE MULTI-GUARD WAS NOT THE NORMAL RAPID DRIP - IT APPEARED TO BE A PRESSURIZED SPRAY. EACH TIME, THE CUSTOMER REPLACED THE SALINE SIDE MPAT AND CONTINUED WITH THE SET-UP PROCEDURE. THERE WERE NO INJURIES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AVANTA MULTI-PT DISPOSABLE SET ANGIOGRAPHIC TUBING SET DXT MEDRAD, INC. 3018231 820007

    Patients

    Seq Age Sex Outcome Treatment
    1 AVANTA FLUID MGMT INJECTION SYSTEM