BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VITAL SIGNS CATHETER MOUNT, DISPOSABLE WITH EXPANDABLE TUBE

    MDR report key: 10337293 · Received July 29, 2020

    Report

    Report Number
    3004050971-2020-00005
    Event Type
    Injury
    Date Received
    July 29, 2020
    Date of Event
    June 29, 2020
    Report Date
    June 30, 2020
    Manufacturer
    VYAIRE MEDICAL
    Product Code
    CAH
    PMA / PMN Number
    K031653
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE MANUFACTURING DHR RECORD OF THE COMPLAINT LOT (LOT # 201194) SHOWED THE COMPLAINT LOT WERE MANUFACTURED ACCORDING TO THE PROCESS MANUFACTURING REQUIREMENT AND HAVE NO ABNORMAL ISSUE . THE TEST OF RETAIN LOT SAMPLE(LOT # 201194) ALSO COMPLIED TO SPECIFICATION REQUIREMENT AND NO ABNORMALITY WAS FOUND. IN ADDITION, SINCE THE STATUS OF RETURN SAMPLE AND THE APPLICATION PARAMETER/INFORMATION ARE UNKNOWN, THE ACTUAL FAILURE ANALYSIS OF THE COMPLAINT PRODUCT CANNOT BE CONDUCTED, THEREFORE, THE ACTUAL CAUSE OF THE COMPLAINT EVENT CANNOT BE DETERMINED . VYAIRE MEDICAL WILL SUBMIT A SUPPLEMENTAL REPORT IN ACCORDANCE WITH 21 CFR SECTION 803.56 IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 1

    AT THIS TIME, VYAIRE HAS NOT RECEIVED THE SUSPECT DEVICE/COMPONENT FOR EVALUATION. THEREFORE, NO ROOT CAUSE COULD BE DETERMINED YET. VYAIRE MEDICAL WILL SUBMIT A SUPPLEMENTAL REPORT IN ACCORDANCE WITH 21 CFR SECTION 803.56 IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE PATIENT UNDERWENT NEUROSURGICAL INTERVENTION WHICH LASTED FOR ABOUT 6 HOURS (AVERAGE). DURING THE OPERATION, THE PATIENT'S RESPIRATORY PRESSURE INCREASED, PREVENTING VENOUS RETURN, AND THE ANESTHETIST HAD TO PERFORM RE-CURARIZATION TO COMPENSATE. AT THE END OF THE PROCEDURE, IT WAS NOTICED BY THE ANESTHETIST AND OPERATING ROOM NURSE THAT THE VITAL SIGNS FILTER WAS COMPLETELY SOAKED WITH WATER INCLUDING THE RING CONNECTOR, EXPLAINING THE RESPIRATORY DYSFUNCTION. EVERYTHING WENT TO NORMAL AFTER CHANGING THE FILTER, AND NO FURTHER CONSEQUENCE TO THE PATIENT AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    805462 VITAL SIGNS CATHETER MOUNT, DISPOSABLE WITH EXPANDABLE TUBE FILTER, BACTERIAL, BREATHING-CIRCUIT CAH VYAIRE MEDICAL VITAL SIGNS¿ CATHETER MOUNT, DISPOSABLE WITH EXPANDABLE TUBE, (15MMF - 22MMF), 1

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention