BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IRRAFLOW ACTIVE FLUID EXCHANGE SYSTEM

    MDR report key: 16676340 · Received April 4, 2023

    Report

    Report Number
    3013508628-2023-00003
    Event Type
    Injury
    Date Received
    April 4, 2023
    Date of Event
    March 21, 2023
    Report Date
    April 4, 2023
    Manufacturer
    IRRAS USA INC
    Product Code
    GWM
    PMA / PMN Number
    K222471
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    "PT WENT TO CT FOR 24HR FOLLOW-UP AND IT WAS DISCOVERED PT HAD A MASSIVE PNEUMOCEPHALUS DEVELOPING. ORIGINAL CONTROL UNIT SETTINGS WERE HIGH OF 25, LOW -5, TREAT ABOVE TURNED OFF, RATE OF 60ML/HR 2MG TPA IN 1L NS, WITH A DRAINAGE BAG HEIGHT OF 0. IT WAS RECOMMENDED TO THE PATIENT'S CAREGIVERS THAT THEY CHECK FOR ANY LEAKS, NONE WERE FOUND. I (IRRAS NEUROCARE SPECIALIST) ASKED THE CAREGIVERS TO CHECK FOR ANY AIR IN THE IRRIGATION LINES, NONE WERE FOUND.THEY WERE THEN ASKED TO CHECK THE CATHETER'S EXIT SITE FROM THE SCALP. NO CSF LEAKS WERE DETECTED. IT WAS SUGGESTED TO THE CAREGIVERS TO ADD SOME REINFORCEMENT SUTURES, TO WHICH, CAREGIVERS SAID THEY WOULD ADD. THIS ISSUE OCCURRED DURING IVH TREATMENT ON A 42-YEAR OLD MALE PATIENT. THE TREATMENT WAS CONTINUED, BUT THE DRAINAGE BAG HEIGHT WAS RAISED TO 10 CMH2O. THE EXPRESSED PRIMARY FEAR WAS THAT DR. KELLNER WAS WORRIED THAT THE PT COULD DEVELOP AN ACUTE SUBDURAL AND THAT THERE MAY HAVE BEEN A NEGATIVE PRESSURE CAUSED IN THE SYSTEM, THAT PULLED AIR INTO THE SKULL.". "BACKGROUND: EARLY MORNING ~ 2 AM, PT HAD 56 CC DUMP OF CSF (CLINICALLY SIGNIFICANT), BROUGHT DRAINAGE BAG UP TO 4-5 CMH20 TO COMPENSATE. FOLLOWUP CT RESULTED IN DETECTION OF THE PNEUMOCEPHALUS. THERE WAS NO AIR IN IRRIGATION LINE. EVENT HAPPENED WHILE PT SLEEPING. STILL NEED KEY PIECE AS TO WHAT CAUSED THE PNEUMOCEPHALUS; POSSIBLE BUT UNLIKELY THAT PT ADJUSTED SETTINGS ON UNIT, OR DROPPED BAG HEIGHT. PT MORE LIKELY SAT UP IN BED (COUGHING, SNEEZING, FOR EXAMPLE.). HOSPITAL UNIT IS SHORT-STAFFED, LIKELY PT GOT UP UNSUPERVISED. PT HAD NAUSEA THROUGHOUT THE DAY, WAS ON NASAL CANNULA OXYGEN; LOC WAS ALERT AND ORIENTED TIMES 4; PT REGAINED FULL NEUROLOGICAL STATUS.". "UNABLE TO CONCLUSIVELY DETERMINE ROOT CAUSE. CSF DUMP MAY HAVE LEFT A VOID THAT RESULTED IN AIR FILLING SUBDURAL SPACE (NOT VENTRICULAR PNEUMOCEPHALUS), RESULTING IN HEMATOMA AND REQUIRING MEDICAL INTERVENTION. WAS ABLE TO EVACUATE AIR BY SUCTIONING. PT IS CONTINUING THERAPY. THIS IS NOT A DEVICE FAILURE AS IT WAS FUNCTIONING AS INTENDED AND DESIGNED".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1130433 IRRAFLOW ACTIVE FLUID EXCHANGE SYSTEM CONTROL UNIT 4.0 GWM IRRAS USA INC 4.0

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Male Other