BEUDAMED
    FDA Adverse Event Other Summary report: N

    AVANTA FLUID MGMT SYSTEM

    MDR report key: 3894203 · Received June 9, 2014

    Report

    Report Number
    2520313-2014-00031
    Event Type
    Other
    Date Received
    June 9, 2014
    Date of Event
    May 2, 2014
    Report Date
    May 22, 2014
    Manufacturer
    BAYER MEDICAL CARE, INC.
    Product Code
    DXT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A SYS SERVICE CHECK OF THE AVANTA FLUID MGMT SYS SERIAL NUMBER (B)(4) WAS COMPLETED ON MAY 5, 2014 WHICH CONFIRMED THAT THE INJECTOR WAS OPERATING WITHIN BAYER R & I SPECIFICATIONS. BAYER R & I SERVICE REVIEWED THE SYSTEM'S LOG FILES AND FOUND THAT THERE WERE MULTIPLE 3702 ERROR MESSAGES WHICH INDICATE THAT THE SYSTEM WAS PRESENTING MULTIPLE AIR-IN-LINE ERROR MESSAGES PRIOR TO AND UP TO THE REPORTED EVENT. VISUAL EXAMINATION OF THE AVANTA FLUID MGMT SYS FOUND THAT THE WINDOW WAS MISSING FROM ONE OF THE AIR DETECTOR INDICATOR (ADI) DOORS. THIS WINDOW IS DESIGNED TO HOLD THE TUBING SET IN THE AIR DETECTOR ASSEMBLY. IF THE WINDOW IS NOT PRESENT, THE TUBING SET COULD DISLODGE FROM THE SENSOR AND PRESENT A FALSE-POSITIVE AIR IN LINE ERROR MESSAGE. THE AVANTA FLUID MGMT INJECTION SYSTEM CONTAINS A GROSS AIR DETECTION FEATURE WHICH IS INTENDED TO ASSIST QUALIFIED MED PROFESSIONAL USERS/OPERATORS DURING INJECTIONS TO DETECT GROSS AIR CONTAINED IN THE MULTI-PT DISPOSABLE SET. OPERATOR VIGILANCE IS ALWAYS REQUIRED TO ELIMINATE POTENTIAL AIR HAZARDS DURING USE. THE MULTI-PT DISPOSABLE SET (MPAT) AND THE SINGLE-PT DISPOSABLE SET (SPAT) THAT WERE IN USE DURING THE PROCEDURE WERE DISCARDED BY THE SITE; HOWEVER, THE SITE WAS ABLE TO PROVIDE LOT NUMBERS FROM THE INVENTORY ON HAND AT THE TIME. BAYER R & I QUAL ASSURANCE PRODUCT ANALYSIS EXAMINED RETAINED SAMPLES FROM MPAT, LOT NUMBER 140403, AND SPAT, LOT NUMBER 158404. TESTING CONCLUDED THAT THE RETAINED DISPOSABLES PERFORMED TO SPECIFICATION WITH NO PROBLEMS OBSERVED. ADDITIONAL APPLICATIONS TRAINING WAS OFFERED; HOWEVER, THE SITE DECLINED. THE SITE CONTINUES TO USE THE AVANTA FLUID MGMT SYS AFTER THE REPORTED EVENT- NO FURTHER ISSUES WERE REPORTED.

    Description of Event or Problem · 1

    BAYER R & I WAS NOTIFIED OF AN ALLEGED AIR INJECTION THAT HAD OCCURRED DURING A DIAGNOSTIC CORONARY ANGIOGRAPHIC PROCEDURE WHILE THE PT WAS CONNECTED TO THE AVANTA FLUID MGMT SYSTEM. AN AIR BUBBLE WAS VISUALIZED UNDER FLUOROSCOPY AT A BIFURCATING SITE OF THE OBTUSE MARGINAL (OM) GRAFT SYSTEM. THE PHYSICIAN USED AN EXPORT CATHETER TO EXTRACT THE AIR BUBBLE WITHOUT INCIDENT. THE PT REMAINED STABLE WITH NO OTHER SIDE EFFECTS NOTED. NO INJURY OR ADVERSE EVENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    334354 AVANTA FLUID MGMT SYSTEM ANGIOGRAPHIC INJECTOR DXT BAYER MEDICAL CARE, INC. AVA 500 PEDL

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention