BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AVANTA FLUID MANAGEMENT SYSTEM

    MDR report key: 16427390 · Received February 23, 2023

    Report

    Report Number
    2520313-2023-00005
    Event Type
    Injury
    Date Received
    February 23, 2023
    Date of Event
    January 30, 2023
    Report Date
    March 27, 2023
    Manufacturer
    BAYER MEDICAL CARE INC.
    Product Code
    DXT
    PMA / PMN Number
    K050456
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AS INITIALLY REPORTED, THE CUSTOMER INFORMED BAYER THAT THE DISPOSABLES USED DURING THE PROCEDURE HAD BEEN DISCARDED. HOWEVER, THE CUSTOMER LATER ADVISED THAT THE ACTUAL DISPOSABLES HAD BEEN LOCATED AND WERE MADE AVAILABLE FOR EVALUATION. BAYER PRODUCT ANALYSIS RECEIVED AND EXAMINED TWO RETURNED SYRINGES AND ONE RETURNED MULTI-PATIENT ADMINISTRATION SET (MPAT) TUBING ASSEMBLY. FUNCTIONAL TESTING OF THE FIRST SYRINGE AND MPAT TUBING CONCLUDED THAT THE RETURNED PRODUCTS PERFORMED TO SPECIFICATION WITH NO PROBLEMS OBSERVED. THE CUSTOMER ALSO PROVIDED A SECOND SYRINGE FOR EVALUATION; HOWEVER, VISUAL EXAMINATION FOUND THAT PLUNGER WAS OUT OF CORRECT RADIAL ORIENTATION. THIS WOULD HAVE PREVENTED SUCCESSFUL INSTALLATION AND USE BY THE CUSTOMER. PRODUCT ANALYSIS DETERMINED THAT THIS SYRINGE WOULD NOT HAVE BEEN ABLE TO BE UTILIZED DURING THE REPORTED INCIDENT. THE OFFER OF ADDITIONAL CLINICAL APPLICATIONS TRAINING HAS BEEN MADE TO THE CUSTOMER; HOWEVER, THEY HAVE NOT RESPONDED. THE AVANTA FLUID MANAGEMENT SYSTEM OPERATION MANUAL CAUTIONS THE USER AS FOLLOWS: "WARNING: EXPEL ALL AIR FROM THE SYRINGE, DRIP CHAMBERS, CONNECTORS, TUBINGS, TRANSDUCER, AND CATHETER BEFORE CONNECTING THE SYSTEM TO THE PATIENT." THIS INFORMATION DOES NOT CONSTITUTE AN ADMISSION THAT THE DEVICE, THE COMPANY, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO A REPORTABLE EVENT.

    Additional Manufacturer Narrative · 0

    A SYSTEM SERVICE CHECK OF THE MEDRAD® AVANTA FLUID MANAGEMENT SYSTEM (SN: (B)(4) WAS COMPLETED ON JANUARY 31, 2023, WHICH CONFIRMED THAT THE INJECTOR WAS OPERATING WITHIN BAYER SPECIFICATIONS. THE MULTI-PATIENT DISPOSABLE SET (MPAT) AND THE SINGLE-PATIENT DISPOSABLE SET (SPAT) THAT WERE IN USE DURING THE PROCEDURE WERE DISCARDED BY THE SITE; HOWEVER, THEY WERE ABLE TO PROVIDE A LOT NUMBER FOR THE AVANTA SYRINGE. FUNCTIONAL TESTING OF A RETAINED SYRINGE, LOT NUMBER: 8421051, A LAB STOCK MPAT AND A LAB STOCK SPAT CONCLUDED THAT THE DISPOSABLES PERFORMED TO SPECIFICATION WITH NO PROBLEMS OBSERVED. THE OFFER OF ADDITIONAL CLINICAL APPLICATIONS TRAINING HAS BEEN MADE TO THE CUSTOMER; HOWEVER, THEY HAVE NOT RESPONDED. THE AVANTA FLUID MANAGEMENT SYSTEM OPERATION MANUAL CAUTIONS THE USER AS FOLLOWS: "WARNING: EXPEL ALL AIR FROM THE SYRINGE, DRIP CHAMBERS, CONNECTORS, TUBINGS, TRANSDUCER, AND CATHETER BEFORE CONNECTING THE SYSTEM TO THE PATIENT." THIS INFORMATION DOES NOT CONSTITUTE AN ADMISSION THAT THE DEVICE, THE COMPANY, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO A REPORTABLE EVENT.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THE FOLLOWING: AN 81 YEAR OLD MALE PATIENT WAS UNDERGOING A CORONARY ANGIOGRAPHY PROCEDURE WHILE CONNECTED TO A MEDRAD® AVANTA FLUID MANAGEMENT SYSTEM (SN: (B)(4). DURING THE PROCEDURE, THE PATIENT EXPERIENCED SLIGHT CHEST PAIN AND AN ELEVATED ST SEGMENT WAS OBSERVED ON THE ELECTROCARDIOGRAM (ECG). VASODILATOR MEDICATIONS WERE IMMEDIATELY ADMINISTERED AFTER WHICH THE PATIENT'S CONDITION STABILIZED. UPON REVIEW OF THE IMAGES, THE PHYSICIAN OBSERVED A SMALL AMOUNT OF AIR WITHIN THE VASCULATURE. THE PATIENT WAS REPORTED TO BE FINE WITH NO OTHER SIDE EFFECTS NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    594289 AVANTA FLUID MANAGEMENT SYSTEM ANGIOGRAPHIC INJECTOR DXT BAYER MEDICAL CARE INC. 58746413

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Male Other AVANTA SYRINGE - AVA 500 SYR - LOT 8421051| MULTI-PATIENT DISPOSABLE SET - LOT UNKNOWN| SINGLE-PATIENT DISPOSABLE SET - LOT UNKNOWN