BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SECHRIST AIR/OXYGEN MIXER MODEL 3500CP-G

    MDR report key: 17541948 · Received August 14, 2023

    Report

    Report Number
    2020676-2023-00016
    Event Type
    Injury
    Date Received
    August 14, 2023
    Date of Event
    July 31, 2023
    Report Date
    August 14, 2023
    Manufacturer
    SECHRIST INDUSTRIES, INC.
    Product Code
    DTX
    PMA / PMN Number
    K023745
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CUSTOMER REPORTED SECHRIST UNIT WAS IN USE WITH ANOTHER MEDICAL DEVICE ON A PATIENT. SECHRIST DEVICE DID NOT CAUSE OR CONTRIBUTE TO THE REPORTED ISSUE, PER THE CUSTOMER. THE UNIT WAS CONTAMINATED WITH BLOOD FROM THE SETUP WITH THE OTHER MEDICAL DEVICE. NO PATIENT INJURY WAS REPORTED. NO DEVICE MALFUNCTION WAS REPORTED. WE ARE REPORTING TO FDA SINCE OUR DEVICE WAS IN USE AT THE TIME OF THIS BLOOD INCIDENT. AT THIS TIME, THERE IS NO EVIDENCE THAT A MANUFACTURING NON-CONFORMITY CONTRIBUTED TO THE REPORTED COMPLAINT AND THE INSTRUCTIONS FOR USE (IFU) WERE REVIEWED AND DETERMINED TO PROVIDE ADEQUATE INSTRUCTIONS AND WARNINGS FOR THE SAFE AND EFFECTIVE USE OF THE DEVICE. THEREFORE, NO CORRECTIVE OR PREVENTIVE ACTIONS ARE REQUIRED. ALL COMPLAINTS ARE TRENDED BY MANAGEMENT ON A MONTHLY BASIS.AS PART OF THIS MONTHLY REVIEW, ANY EXCURSION ABOVE THE CONTROL LIMITS FOR THIS FAILURE MODE WILL BE ASSESSED, DOCUMENTED, AND ACTED UPON AS WARRANTED. MANUFACTURER REFERENCE FILE NO. (B)(4).

    Description of Event or Problem · 0

    CUSTOMER CALLED TO INQUIRE ABOUT OVERHAULING UNIT THAT HAD BEEN CONTAMINATED WITH BLOOD. NO PATIENT INJURY WAS REPORTED. UNIT WAS CONNECTED TO ANOTHER MEDICAL DEVICE AT TIME OF BLOOD INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    51760 SECHRIST AIR/OXYGEN MIXER MODEL 3500CP-G GAS CONTROL UNIT, CARDIOPULMONARY BYPASS DTX SECHRIST INDUSTRIES, INC. 3500CP-G

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown