BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACIST

    MDR report key: 11979178 · Received June 10, 2021

    Report

    Report Number
    2134243-2021-00009
    Event Type
    Malfunction
    Date Received
    June 10, 2021
    Date of Event
    May 11, 2021
    Report Date
    May 12, 2021
    Manufacturer
    ACIST MEDICAL SYSTEMS
    Product Code
    DXT
    UDI-DI
    30841716102685
    PMA / PMN Number
    K010390
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H3: REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED ON JULY 26, 2021, FOR THE FOLLOWING CVI CONSUMABLE KIT LOT USED DURING THE EVENT, THE ACIST MANIFOLD KIT, MODEL BT2000, LOT 31520V. THIS REVIEW CONFIRMED THAT THERE WERE NO QUALITY ISSUES DURING THE MANUFACTURING OF THIS LOT RELATED TO THE REPORTED EVENT. THE KIT WAS DISCARDED BY THE USER FACILITY AFTER THE EVENT. BASED ON THE INFORMATION PROVIDED BY THE USER FACILITY THAT THE TRANSDUCER CARTRIDGE DIDN'T SNAP COMPLETELY INTO THE TRANSDUCER BACKPLATE, THE CAUSE OF THE ISSUE MAY BE A MOLDING DEFECT OF THE TRANSDUCER CARTRIDGE, ALTHOUGH THIS CANNOT BE CONCLUSIVELY CONFIRMED WITHOUT INVESTIGATING THE ACTUAL BT2000 MANIFOLD KIT USED DURING THE EVENT. THE ACIST MEDICAL ADVISORY BOARD MEMBER PROVIDED THE FOLLOWING CLINICAL ASSESSMENT: INACCURATE PRESSURE READING DOES POSE A RISK TO THE PATIENT. IN THIS CASE, THE ADMINISTRATION OF ATROPINE WHEN THE PATIENT WAS ALREADY HYPERTENSIVE, DOES EXPOSE THE PATIENT TO UNNECESSARY RISK. THE CAUSE OF THE EVENT IS INCONCLUSIVE. THIS REPORT IS CONSIDERED CLOSED.

    Additional Manufacturer Narrative · 1

    PATIENT AGE OR DATE OF BIRTH: PATIENT AGE AND BIRTHDATE ARE UNKNOWN. ESTIMATED AGE AND BIRTHDATE ARE ENTERED INTO THESE FIELDS. DEVICE EVALUATED BY MANUFACTURER: THE CONSUMABLE KITS USED DURING THE EVENT WERE DISCARDED. A REVIEW OF THE DEVICE HISTORY RECORD WILL BE COMPLETED FOR THE BT2000 MANIFOLD KIT, LOT 31520V, USED DURING THE EVENT AND WILL BE PROVIDED IN A FOLLOW-UP REPORT.

    Description of Event or Problem · 1

    DURING AN ANGIOGRAPHIC PROCEDURE USING THE ACIST ANGIOGRAPHIC INJECTION SYSTEM, MODEL CVI, THE USER REPORTED THE PATIENT'S BLOOD PRESSURE READING WAS CONSISTENTLY 40 MMHG SYSTOLIC ON THE HOSPITAL'S HEMODYNAMIC MONITORING SYSTEM. DUE TO THIS READING, THE PATIENT WAS ADMINISTERED ATROPINE. THE USER OBSERVED THAT THE TRANSDUCER CARTRIDGE OF THE ACIST MANIFOLD KIT, MODEL BT2000, WAS NOT CLICKED INTO PLACE ON THE TRANSDUCER BACKPLATE, CAUSING THE INACCURATE PRESSURE READING. THE PATIENT'S BLOOD PRESSURE READING WAS 170 SYSTOLIC MMHG ON THE NON-INVASIVE CUFF PRESSURE. THE PATIENT ALSO REQUIRED AN ADDITIONAL DIAGNOSTIC PROCEDURE (TRANSESOPHAGEAL ECHOCARDIOGRAM).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    876888 ACIST INJECTOR AND SYRINGE, ANGIOGRAPHIC, PRODUCT CODE: DXT ACIST MEDICAL SYSTEMS BT2000 SINGLE USE MANIFOLD KIT 31520V 30841716102685

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Other