BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AVANTA FLUID MANAGEMENT SYSTEM

    MDR report key: 3111265 · Received May 8, 2013

    Report

    Report Number
    2520313-2013-00023
    Event Type
    Injury
    Date Received
    May 8, 2013
    Date of Event
    April 11, 2013
    Report Date
    April 12, 2013
    Manufacturer
    MEDRAD
    Product Code
    DXT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A SYSTEM SERVICE CHECK OF THE AVANTA FLUID MANAGEMENT SYSTEM, SERIAL #(B)(4), COMPLETED ON (B)(4) 2013 CONFIRMED THAT THE INJECTOR WAS OPERATING WITHIN BAYER R & I SPECS. THE MULTI-PATIENT DISPOSABLE SET (MPAT) AND THE SINGLE-PATIENT DISPOSABLE SET (SPAT) THAT WERE REPORTEDLY IN USE DURING THE ALLEGED EVENT WERE DISCARDED BY THE SITE. THE SITE WAS UNABLE TO PROVIDE THE LOT NUMBERS OF THE DISPOSABLES; THEREFORE, TESTING OF RETAINED SAMPLES WAS NOT POSSIBLE. THE AVANTA FLUID MANAGEMENT SYSTEM OPERATION MANUAL STATES THAT "THE OPERATOR IS REQUIRED TO EXPEL ALL TRAPPED AIR FROM THE SYRINGE, DRIP CHAMBERS, CONNECTORS, TUBINGS, AND CATHETER BEFORE CONNECTING TO TE PT." OPERATOR VIGILANCE IS ALWAYS REQUIRED TO ELIMINATE POTENTIAL AIR HAZARDS DURING USE. THE CARDIAC CATHETERIZATION LAB MANAGER STATED THE STAFF NOTICED THAT THE CONNECTION BETWEEN THE MULTI-PATIENT DISPOSABLE SYSTEM (MPAT) AND SINGLE PT DISPOSABLE SET (SPAT) WAS LOOSE AND FLUID WAS LEAKING AT THIS CONNECTION DURING THE PROCEDURE. POST PROCEDURE, WITHOUT A PT IN THE ROOM, THE STAFF SET UP FOR THE NEXT PT AND PURPOSELY LOOSENED THE CONNECTION BETWEEN THE MPAT/SPAT TO THE POINT OF FLUID LEAKING AND CAREFULLY WATCHED TO SEE IF ANY AIR ENTERED THE FLUID PATH. NO AIR WAS OBSERVED ENTERING THE FLUID PATH DURING THIS TEST SET-UP. ADD'L APPLICATIONS TRAINING HAS BEEN OFFERED AND ACCEPTED BY THE SITE. THIS TRAINING IS SCHEDULED FOR THE WEEK OF (B)(4) 2013.

    Description of Event or Problem · 1

    THE SITE REPORTED THE FOLLOWING: DURING A CARDIAC CATHETERIZATION, THE PT EXPERIENCED WHAT WAS THOUGHT TO BE AN AIR INJECTION; HOWEVER, THE PHYSICIAN IS NOT SURE IF IT WAS AN AIR INJECTION OR NOT AS AIR WAS NOT SEEN TRAVELING INTO THE LEFT ANTERIOR DESCENDING ARTERY. THE PT DID REQUIRE MEDICAL INTERVENTION INCLUDING THE ADMINISTRATION OF INTRACORONARY NITROGLYCERIN. THE PT FULLY RECOVERED AND THE PROCEDURE WAS COMPLETED WITHOUT FURTHER INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    202397 AVANTA FLUID MANAGEMENT SYSTEM ANGIOGRAPHIC INJECTOR DXT MEDRAD AVA 500 TABL

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention MULTI-PATIENT DISPOSABLE SET (MPAT)| SINGLE-PATIENT DISPOSABLE SET (SPAT)