BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AVANTA MULTI-PATIENT DISPOSABLE SET

    MDR report key: 1586894 · Received January 14, 2010

    Report

    Report Number
    2520313-2010-00003
    Event Type
    Malfunction
    Date Received
    January 14, 2010
    Date of Event
    December 15, 2009
    Report Date
    January 15, 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
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN ANALYSIS OF THE MULTI-PATIENT DISPOSABLE SET RETURNED FROM THE HOSPITAL DETERMINED THAT THERE WAS EVIDENCE OF FLASH IN ONE OF THE MOLDED PLASTIC COMPONENTS AND FLOW RATES WERE AT THE LOWER END OF THE SPECIFICATION. OUR RECORDS INDICATE THAT THIS SITE RECEIVED LOT NUMBER 820007 OF THE MULTI-PATIENT DISPOSABLE SET, WHICH IS CURRENTLY UNDER RECALL FOR THIS ISSUE. THEREFORE, IT IS POSSIBLE THAT THE DEVICE USED DURING THIS EVENT MAY HAVE CONTRIBUTED TO A MALFUNCTION.

    Description of Event or Problem · 1

    THE SITE REPORTED THAT THE SALINE LINE OF THE MULTI-PATIENT DISPOSABLE SET WAS NOT PURGING PROPERLY. THE SALINE WAS COMING OUT IN A MIST INSTEAD OF THE NORMAL STREAM. THIS HAPPENED WITH THREE DIFFERENT MULTI-PATIENT DISPOSABLE SETS. THE STAFF SAVED THE DISPOSABLES BUT NOT THE PACKAGE. THEY CHANGED THE PUMP AND STILL OBSERVED THE SAME PROBLEM. THEY THEN USED A DIFFERENT MULTI-PATIENT DISPOSABLE SET AND IT FUNCTIONED CORRECTLY. THE SITE REPORTED THAT THERE WAS NO PT INJURY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1