BEUDAMED
    FDA Adverse Event Death Summary report: N

    NEUROVENT-P

    MDR report key: 19446510 · Received June 3, 2024

    Report

    Report Number
    3006942548-2024-00007
    Event Type
    Death
    Date Received
    June 3, 2024
    Date of Event
    May 3, 2024
    Report Date
    June 3, 2024
    Manufacturer
    RAUMEDIC AG
    Product Code
    GWM
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER STATEMENT: NO DETAILIED PRODUCT INVESTIGATION IS POSSIBLE SINCE THE CATHETER HAS BEEN DISCARDED BY THE CLINIC AND THE S/N IS NOT AVAILABLE. NONETHELESS PRODUCTION RECORDS FOR ALL POSSIBLE S/NS DELIVERED TO THIS CLINIC WERE CHECKED AND FOUND TO BE OK. FOR EVERY CATHETER THERE IS A FINAL INSPECTION DURING MANUFACTURING PROCESS INCLUDING A 100% INSPECTION OF ICP-MEASUREMENT. THE BEHAVIOR DESCRIBED COULD NOT BE REPRODUCED IN THE CLINIC IN THE PRESENCE OF THE DISTRIBUTOR. THE CABLES USED (NPS2) WERE EXCLUDED AS A SOURCE OF ERROR IN COMPARATIVE MEASUREMENTS IN THE CLINIC. THE PATIENT WAS A NEUROCRITICAL MALE WITH A SEVERE BRAIN INJURY. THE DOCTORS ALREADY EXPECTED A BAD PROGNOSIS AFTER DOING A CT SCAN. THE DOCTOR MENTIONED THAT THE MEASUREMENT WITH THE NEUROVENT-P DID NOT ALTER THE TREATMENT THAT THE PATIENT RECEIVED. THERE ARE CURRENTLY NO TANGIBLE SIGNS OF A MALFUNCTION, BUT ONLY THE USER'S STATEMENT THAT A HIGHER ICP WAS EXPECTED DUE TO THE PATIENT'S CONDITION. THIS IS SUPPORTED BY THE FACT THAT APPROXIMATELY 34,000 OF NEUROVENT-P CATHETER HAVE BEEN SOLD IN THE LAST 3 YEARS AND THERE HAS NOT BEEN A SINGLE MALFUNCTION IN ICP MEASUREMENT.

    Description of Event or Problem · 0

    ON MAY 3RD AND 6TH WE RECEIVED THE FOLLOWING INFORMATION VIA E-MAIL FROM OUR DISTRIBUTOR: MAY, 3RD: "TODAY I HAVE BEEN AT HOSPITAL (B)(6) AFTER THEY REPORTED AN UNUSUAL BEHAVIOR FROM AN ICP MONITORING. AS YOU CAN SEE IN THE FIRST ATTACHED IMAGE, THE ICP MONITORING WAS TOO LOW DURING THE NIGHT (AROUND 5-10). THE DOCTORS EXPECTED A MUCH HIGHER ICP FROM THE PATIENT CONDITION AND AFTER THEY CHANGED THE NPS2, THE SIGNAL INSTANTLY TURNED TO NORMAL RANGE (AROUND 35). THIS SAME PROBLEM HAPPENED TWICE MEANING BOTH NPS2 WERE SHOWING A BAD SIGNAL AND A CORRECT SIGNAL AT DIFFERENT TIMES. I HAVE PERSONALLY BEEN AT THE HOSPITAL AND I HAVE COMPARED THE SIGNAL WHEN CONNECTING TO A NEUROSMART LOGO AND WHEN CONNECTING TO BOTH NPS2, THE DISPLAYED SIGNAL THAT I HAVE OBSERVED HAS BEEN THE SAME IN BOTH CASES (SEE THE IMAGES ATTACHED) MEANING THAT THERE WAS APPARENTLY NO PROBLEM IN THAT NPS2. I HAVE ALREADY WARNED THEM TO KEEP THE CATHETER FOR FURTHER INVESTIGATION. DO YOU HAVE ANY IDEA OF WHAT MIGHT BE HAPPENING HERE?" MAY, 6TH: "THE REPORTED PROBLEM WAS THE SUDDEN AND DRASTIC CHANGE FROM APPROX. 6 TO 35 MMHG. FOR FURTHER INFORMATION ON THE PATIENT, HE WAS A NEUROCRITICAL MALE WITH A SEVERE BRAIN INJURY. THE DOCTORS ALREADY EXPECTED A BAD PROGNOSIS AFTER DOING A CT SCAN AND THE ICP IN A NORMAL RANGE WAS NOT EXPECTED DUE TO THE CONDITION OF THE PATIENT. ANYWAYS, THE DOCTOR MENTIONED THAT THIS MEASUREMENT DID NOT ALTER THE TREATMENT THAT THE PATIENT RECEIVED. UNFORTUNATELY, A FEW HOURS AFTER OUR VISIT, THE PATIENT PASSED AWAY. AFTER THE PATIENT PASSED AWAY, THE HOSPITAL COULD NOT KEEP THE CATHETER. "

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    629561 NEUROVENT-P NEUROLOGICAL CATHETER GWM RAUMEDIC AG 092946-001

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Death