BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AVANTA FLUID MANAGEMENT SYSTEM

    MDR report key: 15199914 · Received August 10, 2022

    Report

    Report Number
    2520313-2022-00028
    Event Type
    Injury
    Date Received
    August 10, 2022
    Date of Event
    June 24, 2022
    Report Date
    August 10, 2022
    Manufacturer
    BAYER MEDICAL CARE, INC.
    Product Code
    DXT
    PMA / PMN Number
    K050456
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    UPON RECEIVING THE MEDWATCH NOTICE, A BAYER SYSTEM SERVICE INJECTOR CHECKOUT OF THE MEDRAD® AVANTA FLUID MANAGEMENT SYSTEM (SN (B)(4)), WAS DISPATCHED. HOWEVER WHEN THE BAYER SERVICE REPRESENTATIVE CONTACTED THE RISK MANAGEMENT REPRESENTATIVE VIA PHONE TO SET UP THE SITE VISIT, THE CUSTOMER DECLINED THE SERVICE OFFER. THE SUBJECT DISPOSABLES AT THE TIME OF THE INCIDENT WERE UNABLE TO BE RETURNED FOR INVESTIGATION; HOWEVER, THE CUSTOMER PROVIDED THE LOT NUMBER FOR THE SINGLE-PATIENT DISPOSABLE SET (SPAT) ON THE MEDWATCH REPORT. BAYER PRODUCT ANALYSIS FUNCTIONALLY TESTED THE RETAINED SPAT (LOT NUMBER 214003) AND CONCLUDED THAT THE DISPOSABLES PERFORMED TO SPECIFICATION WITH NO PROBLEMS OBSERVED. THE MEDRAD® 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 THE PATIENT. AN OFFER OF ADDITIONAL CLINICAL APPLICATIONS TRAINING WAS MADE TO THE CUSTOMER HOWEVER NO RESPONSE HAS BEEN RECEIVED AT THIS TIME. IN THE EVENT THAT ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP WILL BE SUBMITTED. 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

    ON JULY 15, 2022, BAYER MEDICAL CARE INC., RECEIVED A COPY OF MEDWATCH (MW5110736) VIA EMAIL THAT CONTAINED THE FOLLOWING: "WHILE THE PATIENT WAS UNDERGOING CARDIAC ANGIOPLASTY/STENTING THE MEDRAD IPX1 POWER INJECTOR MALFUNCTIONED. THIS WAS AT THE END OF THE CASE, THE CARDIOLOGIST NEEDED ONE MORE PICTURE OF THE HEART. WHILE THE STAFF WERE TROUBLESHOOTING THIS THE STOPCOCK WAS OFF TO THE PATIENT. THE CARDIOLOGIST SAW AIR ENTER THE CORONARIES. NO ONE WAS INJECTING ANYTHING, DOCTOR TRIED TO WITHDRAWAL AIR FROM THE VESSEL, BUT THE PATIENT WENT INTO CARDIAC ARREST. PATIENT STABILIZED AFTER RESUSCITATION, TAKEN TO ICU, SLOW TO WAKE UP- CLINICAL PICTURE CONSISTENT WITH ANOXIC BRAIN INJURY. PATIENT HAD AN AIR EMBOLISM WHILE THE PATIENT WAS HAVE A PCI, MEDRAD AUTO INJECTOR MALFUNCTIONED AND AIR ENTERED THE PATIENTS CORONARIES AS SEEN BY THE CARDIOLOGIST ON FLUOROSCOPY. THIS REPORT IS FOR THE TUBING USED IN THE MEDRAD. FDA SAFETY REPORT ID # (B)(4)." BAYER MADE MULTIPLE ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION ASSOCIATED WITH THIS INCIDENT BEYOND WHAT WAS PROVIDED IN THE ABOVE MEDWATCH. HOWEVER, DESPITE REPEATED REQUESTS FOR FURTHER CLARIFYING INFORMATION, NO SUPPLEMENTARY INFORMATION HAS BEEN PROVIDED BY THE CUSTOMER AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1522468 AVANTA FLUID MANAGEMENT SYSTEM ANGIOGRAPHIC INJECTOR DXT BAYER MEDICAL CARE, INC. 59352532

    Patients

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