BEUDAMED
    FDA Adverse Event Death Summary report: N

    EMPOWER CTA

    MDR report key: 12306989 · Received August 11, 2021

    Report

    Report Number
    2134243-2021-00011
    Event Type
    Death
    Date Received
    August 11, 2021
    Date of Event
    July 11, 2021
    Report Date
    July 12, 2021
    Manufacturer
    ACIST MEDICAL SYSTEMS
    Product Code
    IZQ
    PMA / PMN Number
    K071378
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    H3: THE COMPUTED TOMOGRAPHY (CT) SCANS WERE RETURNED TO ACIST FOR EVALUATION BY THE ACIST MEDICAL ADVISORY BOARD (MAB). UPON COMPLETION OF THE REVIEW, THE FOLLOWING ASSESSMENT WAS PROVIDED. "CT SCANS OF THE HEAD WERE REVIEWED, AND NO AIR WAS VISIBLE. BASED ON THE PATIENT'S STATUS (ACUTE STROKE) AND THE ABSENCE OF AIR IDENTIFIED ON THE PATIENT'S CT SCANS, THERE IS INSUFFICIENT EVIDENCE TO INDICATE IV AIR ADMINISTRATION OCCURRED AND THUS NO CAUSAL RELATIONSHIP ESTABLISHED BETWEEN THE EMPOWERCTA INJECTION SYSTEM AND THE REPORTED PATIENT DEATH. " EVALUATION OF THE ACIST DEVICE PROVIDED NO EVIDENCE OF A DEVICE MALFUNCTION AND MAB REVIEW OF THE PATIENT'S CT SCANS CONCLUDED THERE WAS NO EVIDENCE TO INDICATE AN AIR INJECTION OCCURRED. EVALUATION OF THE AVAILABLE INFORMATION CONCLUDES NO CAUSAL RELATIONSHIP BETWEEN THE EMPOWERCTA INJECTION SYSTEM AND THE REPORTED PATIENT DEATH.

    Additional Manufacturer Narrative · 1

    THE EMPOWERCTA INJECTION SYSTEM, MODEL CTA, SERIAL NUMBER (B)(4) WAS RETURNED FOR EVALUATION ON 13 JULY 2021. THE INJECTOR SYSTEM WAS FUNCTIONALLY TESTED AND MET THE PRE-ESTABLISHED SPECIFICATIONS. A REVIEW OF THE DEVICE HISTORY WAS PERFORMED WITH NO FINDINGS RELATED TO THE REPORTED COMPLAINT. THERE WAS NO EVIDENCE OF DEVICE MALFUNCTION RELATED TO THE REPORTED EVENT. A COPY OF THE CT PROCEDURE IMAGES AND ADDITIONAL INFORMATION ON THE EVENT HAVE BEEN REQUESTED, BUT NOT YET PROVIDED. THE CONSUMABLE KITS USED DURING THE EVENT ARE NOT AVAILABLE FOR EVALUATION. THE LOT NUMBER OF THE EMPOWERCT SYRINGE USED DURING THE EVENT WAS PROVIDED AND REVIEW OF THE DEVICE HISTORY RECORDS FOR THIS LOT, 1866032008, WAS COMPLETED ON 3 AUGUST 2021. THERE WERE NO QUALITY ISSUES OR DEVIATIONS DURING THE MANUFACTURING OF THIS LOT RELATED TO THE REPORTED EVENT. UPON COMPLETION OF THE EVALUATION OF THE REQUESTED INFORMATION AND/OR IMAGES FROM THE EVENT, A FOLLOW-UP MDR WILL BE SUBMITTED TO FDA.

    Description of Event or Problem · 1

    THE PATIENT WAS ADMITTED BY AN EMERGENCY PHYSICIAN ON SUSPICION OF CEREBRAL INFARCTION. APPROXIMATELY 20 MINUTES AFTER A COMPUTED TOMOGRAPHY (CT) SCAN WITH AN EMPOWERCTA INJECTION SYSTEM, MODEL CTA, THE PATIENT WENT INTO CARDIAC ARREST. THE PATIENT IS DECEASED. THE USER FACILITY CONSIDERED THAT AIR MAY HAVE BEEN INJECTED INTO THE PATIENT, BUT THIS WAS NOT CONCLUSIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1205289 EMPOWER CTA INJECTOR, CONTRAST MEDIUM, AUTOMATIC, PRODUCT CODE: IZQ IZQ ACIST MEDICAL SYSTEMS EMPOWER CTA

    Patients

    Seq Age Sex Outcome Treatment
    1 94 YR Death CTA CONNECTING TUBE, LOT IAQVJ-1903.| CTA CONNECTING TUBE, LOT IAQVJ-1903