BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACIST

    MDR report key: 1911281 · Received November 23, 2010

    Report

    Report Number
    2134243-2010-00017
    Event Type
    Injury
    Date Received
    November 23, 2010
    Date of Event
    October 28, 2010
    Report Date
    November 23, 2010
    Manufacturer
    ACIST MEDICAL SYSTEMS, INC.
    Product Code
    DXT
    PMA / PMN Number
    K991103
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A REPRESENTATIVE OF ACIST VISITED THE HOSPITAL ON NOVEMBER 2, 2010. THE HOSPITAL REPRESENTATIVE ACKNOWLEDGED THAT THE SECOND PHYSICIAN DID NOT REALIZED THAT THE FLOW RATE AND VOLUME SETTINGS WERE SET AT A FLOW RATE AND VOLUME USED FOR AN LV INJECTION, SO A LARGER VOLUME OF CONTRAST WAS INJECTED AT A HIGHER FLOW RATE INTO THE PT'S LEFT CORONARY ARTERY, CAUSING THE PT TO FIBRILLATE AND REQUIRING INTERVENTION (DEFIBRILLATION). THE HOSPITAL DID NOT PROVIDE THE FLOW RATE AND VOLUME SETTINGS THAT WERE IN USE AT THE TIME OF THE EVENT. PER THE ACIST CVI USER'S MANUAL, THE PARAMETER RANGES FOR AN LCA INJECTION ARE: FLOW RATE - 0.8 - 10.0 ML/SECOND AND VOLUME - 0.8 - 20.0 ML. THE PARAMETER RANGES FOR AN LV INJECTION ARE: FLOW RATE - 0.8 - 40.0 ML/SECOND AND VOLUME - 0.8 - 99.9 ML. ACIST ENGINEERING PERSONNEL REVIEWED THE INFO FROM THIS EVENT AND STATED THAT THERE IS NO EVIDENCE OF MALFUNCTION OF THE INJECTOR SYSTEM BASED ON THE INFO PROVIDED BY THE HOSPITAL. THE FLOW RATE AND VOLUME CAN BE SET IN THE LCA INJECTION SETTING FOR A FLOW RATE AND VOLUME THAT WOULD BE USED FOR AN LV INJECTION. THE ACIST USER'S MANUAL INCLUDES THE FOLLOWING WARNINGS: "HIGH FLOW RATE INJECTIONS: HIGH FLOW RATE INJECTIONS CAN CAUSE PT INJURY OR DEATH. USE EXTREME CARE WHEN SETTING THE FLOW RATE TO AVOID UNINTENTIONALLY SETTING A HIGH FLOW RATE INJECTION. WHEN HIGH FLOW RATE INJECTION IS REQUIRED, BE SURE TO SELECT A PRESSURE SETTING THAT DOES NOT EXCEED THE RATED PRESSURE OF THE SELECTED CATHETER. INJECTION SYSTEM SETTING: CHECK THE ACIST SYSTEM SETTINGS BEFORE INJECTION, AND VERIFY APPROPRIATENESS OF ALL INJECTION PARAMETERS BEFORE INJECTING." BASED ON THE INFO PROVIDED BY THIS EVENT, THERE IS NO EVIDENCE OF DEVICE MALFUNCTION. THE CAUSE OF THE EVENT IS CONTRIBUTED TO USE ERROR.

    Description of Event or Problem · 1

    NARRATIVE: USER FACILITY REPORTED: PHYSICIAN WAS PERFORMING A LEFT VENTRICLE (LV) INJECTION WITH THE INJECTION SETTING SELECTED FOR A LEFT CORONARY ARTERY (LCA) INJECTION. THE PHYSICIAN DOING THE NEXT PT PROCEDURE DID NOT REALIZE THAT, ALTHOUGH THE INJECTION SETTING WAS SET FOR AN LCA INJECTION, THE PREVIOUS PHYSICIAN HAD SET THE FLOW RATE AND VOLUME TO A HIGHER FLOW RATE AND LARGER VOLUME USED FOR AN LV INJECTION. THE PHYSICIAN INJECTED THE PT'S LEFT CORONARY ARTERIES WITH A LARGE BOLUS OF CONTRAST AND THE PT FIBRILLATED. THE PT WAS DEFIBRILLATED AND SUBSEQUENTLY RECOVERED. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACIST ANGIOGRAPHIC INJECTION SYSTEM DXT ACIST MEDICAL SYSTEMS, INC. CVI NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R