BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CODA INLINE FILT FOR CO2

    MDR report key: 17050103 · Received June 2, 2023

    Report

    Report Number
    1216677-2023-00088
    Event Type
    Malfunction
    Date Received
    June 2, 2023
    Date of Event
    May 3, 2023
    Report Date
    July 12, 2023
    Manufacturer
    COOPERSURGICAL, INC.
    Product Code
    MQG
    UDI-DI
    00815965020938
    PMA / PMN Number
    K001486
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DISTRIBUTION HISTORY: THIS COMPLAINT UNIT WAS MANUFACTURED AT CSI ON 1/17/2023 UNDER WO #(B)(4). MANUFACTURING RECORD REVIEW: DHR 322809 WAS REVIEWED AND NO NON-CONFORMITIES, RELATED TO THE COMPLAINT CONDITION, WERE NOTED. INCOMING INSPECTION REVIEW: NOT APPLICABLE. SERVICE HISTORY RECORD: NOT APPLICABLE. HISTORICAL COMPLAINT REVIEW: A REVIEW OF THE 2-YEAR COMPLAINT HISTORY SHOWED ONE SIMILAR REPORTED COMPLAINT CONDITION. PRODUCT RECEIPT: THE COMPLAINT UNIT WAS NOT RETURNED. VISUAL EVALUATION: VISUAL EXAMINATION OF THE COMPLAINT UNIT WAS NOT POSSIBLE AS THE UNIT CANNOT BE RETURNED. FUNCTIONAL EVALUATION: A FUNCTIONAL EVALUATION OF THE UNIT WAS NOT POSSIBLE AS THE UNIT CANNOT BE NOT RETURNED. ROOT CAUSE: THE ROOT CAUSE IS ATTRIBUTED TO END USER ERROR. THE IFU STATES THE PRESSURE TO USE ON THE DEVICE IS NOT TO EXCEED 24 PSI. THE CUSTOMER STATED THE PRESSURE WAS SET TO 60 PSI, MORE THAN DOUBLE THE SPECIFIED PRESSURE INDICATED BY THE IFU. THE VERBIAGE SUGGESTS THE CUSTOMER CONCEDES THE LINE MAY HAVE EXCEEDED 60 PSI FOR A SHORT PERIOD OF TIME. NOTE: COMPLAINT CONFIRMATION IS BASED ON THE IMAGE PROVIDED AND THE INFORMATION CONCERNING THE EXPOSURE TO HIGH PRESSURE. A REVIEW OF THE IFU CONFIRMS CLEAR INSTRUCTION TO NOT EXCEED 24 PSI WHEN PRESSURIZING THE LINE TO THE FILTER. DUE TO THE DAMAGE WHEN THIS UNIT WAS EXPOSED TO EXCESSIVE PRESSURE, HHE-23-0193 FOR CODA IN-LINE FILTERS WAS SUBMITTED. COOPERSURGICAL WILL CONTINUE TO MONITOR THIS COMPLAINT CONDITION FOR TRENDS.

    Additional Manufacturer Narrative · 0

    COOPERSURGICAL , INC. IS CURRENTLY INVESTIGATING THE REPORTED CONDITION.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION IS AVAILABLE.

    Description of Event or Problem · 0

    PER DETAILS RECEIVED FROM USER FACILITY ON INCOMING E-COMPLAINT (B)(6): "FILTER FLEW DUE TO HIGH PRESSURE. CAUSE: FILTER WAS APPARENTLY IN A LINE AT 60PSI, IT MIGHT HAVE BEEN AN ACCIDENTAL INCREASE OF PRESSURE. THE FILTERS WERE INSTALLED IN A LINE AT 60PSI" "NO INJURIES."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    972026 CODA INLINE FILT FOR CO2 CODA INLINE FILT FOR CO2 MQG COOPERSURGICAL, INC. CIPR-001 N/A 00815965020938

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other