BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IRRAS

    MDR report key: 13056460 · Received December 21, 2021

    Report

    Report Number
    3017865540-2021-00002
    Event Type
    Malfunction
    Date Received
    December 21, 2021
    Date of Event
    October 26, 2021
    Report Date
    November 12, 2021
    Manufacturer
    IRRAS USA, INC.
    Product Code
    GWM
    UDI-DI
    00868643000401
    PMA / PMN Number
    K171880
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    PER THE CARE TEAM ON SITE, OVERDRAINAGE CAN OCCUR W/ TRADITIONAL EVD TREATMENT AS WELL.

    Additional Manufacturer Narrative · 0

    PER THE CARE TEAM ON SITE, OVERDRAINAGE CAN OCCUR W/ TRADITIONAL EVD TREATMENT AS WELL.

    Description of Event or Problem · 0

    OVERDRAINAGE DURING TREATMENT OF TRAUMATIC IPH RESULTED IN SECONDARY SUBDURAL HEMATOMA. DURING THE TREATMENT OF A TRAUMATIC IPH WITH VENTRICULAR EXTENSION USING THE IRRAFLOW SYSTEM, EXCESSIVE FLUID REMOVAL WAS OBSERVED, AND THE PATIENT DEVELOPED A SECONDARY SUBDURAL HEMATOMA, WHICH WAS POTENTIALLY CAUSED BY OVERDRAINAGE OF CSF FROM THE VENTRICLES. TREATMENT CONTINUED AS NORMAL WITH THE PATIENT'S NEUROLOGICAL EXAM CONTINUING TO IMPROVE FROM THE TIME THAT THE BLEED WAS FIRST OBSERVED. AT THE CONCLUSION OF TREATMENT, THE PATIENT WAS DISCHARGED HOME IN A NORMAL MANNER, AND NO ADDITIONAL PROCEDURES WERE REQUIRED.

    Description of Event or Problem · 0

    OVERDRAINAGE DURING TREATMENT OF TRAUMATIC IPH RESULTED IN SECONDARY SUBDURAL HEMATOMA. DURING THE TREATMENT OF A TRAUMATIC IPH WITH VENTRICULAR EXTENSION USING THE IRRAFLOW SYSTEM, EXCESSIVE FLUID REMOVAL WAS OBSERVED, AND THE PATIENT DEVELOPED A SECONDARY SUBDURAL HEMATOMA, WHICH WAS POTENTIALLY CAUSED BY OVERDRAINAGE OF CSF FROM THE VENTRICLES. TREATMENT CONTINUED AS NORMAL WITH THE PATIENT'S NEUROLOGICAL EXAM CONTINUING TO IMPROVE FROM THE TIME THAT THE BLEED WAS FIRST OBSERVED. AT THE CONCLUSION OF TREATMENT, THE PATIENT WAS DISCHARGED HOME IN A NORMAL MANNER, AND NO ADDITIONAL PROCEDURES WERE REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1955986 IRRAS IRRAFLOW CNS SYSTEM CONTROL UNIT (ICCU 020) GWM IRRAS USA, INC. N/A N/A 00868643000401

    Patients

    Seq Age Sex Outcome Treatment
    1 Male