BEUDAMED
    FDA Adverse Event Death Summary report: N

    KIT CONTAINING CC1.P1 AND THE IP1 INTRODUCER

    MDR report key: 4192805 · Received October 20, 2014

    Report

    Report Number
    9617494-2014-00007
    Event Type
    Death
    Date Received
    October 20, 2014
    Date of Event
    September 23, 2014
    Report Date
    September 24, 2014
    Manufacturer
    GMS - GESELLSCHAFT FUR MEDIZINISCHE SONDENTECHNIK GMS, M
    Product Code
    GWM
    PMA / PMN Number
    K040235
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PROBE WAS DISCARDED BY MISTAKE BY THE CUSTOMER BUT THE CALIBRATION SMART CARD WAS STILL AVAILABLE AND WILL BE SENT BACK. TO DATE, THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS NOT BEEN RECEIVED FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED UPON THE REPORTED INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LICOX IP1P PROBE WAS INSERTED INTO AN APPROPRIATE POSITION IN THE PATIENT'S BRAIN. AFTER THE WARM UP PERIOD, THE LICOX MONITOR WAS READING -2 AND THE BEDSIDE MONITOR WAS READING -15. IT WAS DETERMINED, AFTER CHANGING LICOX CABLES AND MONITORS, THAT THE IP1P PROBE WAS DEFECTIVE. THERE WAS NO PATIENT INJURY OR DEATH ALLEGED. ADDITIONAL INFORMATION WAS REQUESTED AND ON (B)(6) 2014, THE FOLLOWING WAS RECEIVED FROM THE CUSTOMER (REGISTERED NURSE): A (B)(6) MALE PATIENT WITH AN UNDERLYING MEDICAL CONDITION OF SDH (SUBDURAL HEMORRHAGE). EDH (EPIDURAL HEMORRHAGE), AND TBI (TRAUMATIC BRAIN INJURY) HAD THE PROBE/CATHETER IMPLANTED ON (B)(6) 2014. THE PATIENT HAD FALLEN 20 FEET FROM HIS FARM EQUIPMENT. THE DISCREPANCY IN THE PTO2 READING OCCURRED ON (B)64) 2014. THE PATIENT'S NEUROLOGICAL STATUS AT THE TIME OF THE DISCREPANCY WAS GLASGOW COMA SCALE 1-5-1, PUPILS 5 AND PERRL. PATIENT MONITORING WAS CONTINUED DESPITE THE DISCREPANCY. IT WAS CONFIRMED THAT THERE WAS NO PATIENT INJURY OR HARM DUE TO THE PRODUCT PROBLEM. THERE WAS NO SURGICAL DELAY. THE PROBE WAS REMOVED ON THE NIGHT OF (B)(6) 2014 OR THE EARLY MORNING OF (B)(6) 2014. THE CUSTOMER COULD NOT FIND THE EXACT TIME OF REMOVAL. PATIENT OUTCOME WAS REPORTED AS PATIENT "DECEASED ON (B)(6) 2014". ADDITIONAL INFORMATION WAS RECEIVED FROM THE RN ON OCTOBER 2, 2014: THE RN CARE FOR THE PATIENT THE MORNING AFTER THE LICOX WAS INSERTED. THE PTO2 VALUE WAS NOT CHARTED IN THEIR DOCUMENTATION SYSTEM BECAUSE -2 WAS NOT A TRUE VALUE AND THE DOCTORS WERE NOT GOING TO PERFORM INTERVENTIONS BASED ON THE -2 NUMBER. BOTH THE PHILIPS MONITOR AND LICOX MONITOR STATED -2. THE PATIENT'S PROGNOSIS PRIOR TO MONITORING WAS TOO SOON TO PREDICT AT THAT TIME. THE PATIENT WAS A TRAUMA PATIENT AND HAD BEEN ADMITTED FOR LESS THAN 12 HOURS. THE GLASGOW COMA SCALE WAS CLARIFIED AS 1 (NO EYE OPENING) - 5 (MOVING SPONTANEOUSLY/LOCALIZES PAIN) - 1 (NO SPEECH OR ATTEMPTS TO SPEAK). THE PATIENT'S PUPIL SIZE WERE CHARTED AS 5MM AND BRISK FOR THE FEW HOURS ON THE PATIENT BEING ON THE UNIT. AT 0400 PM ON (B)(6) 2014 UNTIL THE END OF PATIENT'S TIME ON UNIT, THE PUPILS WERE 4MM AND BRISK FOR BOTH EYES. THE REASON FOR DISCONTINUATION OF MONITORING ON THE (B)(6) WAS BECAUSE THE PROBE/CATHETER WAS READING -2 AND THE NEUROSURGERY TEAM DID NOT FEEL THIS WAS AN ACCURATE NUMBER. THE PATIENT'S INTRACRANIAL PRESSURE WAS LOW AND PATIENT'S CEREBRAL PERFUSION PRESSURE NUMBERS WERE GREATER THAN 60. THE CAUSE OF THE PATIENT'S DEATH WAS REPORTED AS "THE FAMILY DECIDED TO WITHDRAW CARE BASED ON TRAUMATIC BRAIN INJURY AND POOR PROGNOSIS". THE PATIENT DID NOT HAVE AN AUTOPSY. THE BODY WAS RELEASED BY THE CORONER. ADDITIONAL INFORMATION RECEIVED FROM THE RN ON OCTOBER 6, 2014 WITH THE FOLLOWING: THE NURSE DID NOT KNOW WHAT THE PHILIPS MONITOR WAS READING AFTER THE WARM UP PERIOD. SHE ONLY TOOK OVER ON THE CARE FOR THE PATIENT A FEW HOURS LATER. CT SCANS WITH RESULTS HAVE BEEN REQUESTED FROM THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    667083 KIT CONTAINING CC1.P1 AND THE IP1 INTRODUCER LICOX BOLTS CATHETERS AND KITS GWM GMS - GESELLSCHAFT FUR MEDIZINISCHE SONDENTECHNIK GMS, M 310714

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Death