BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POLE MOUNT ASSEMBLY

    MDR report key: 6901510 · Received September 28, 2017

    Report

    Report Number
    2648988-2017-00044
    Event Type
    Malfunction
    Date Received
    September 28, 2017
    Date of Event
    September 11, 2017
    Report Date
    September 11, 2017
    Manufacturer
    INTEGRA NEUROSCIENCES PR
    Product Code
    JXG
    PMA / PMN Number
    K062599
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION RECEIVED ON 15NOV2017: THE PROBLEM WAS WITH THE SMALLER CLAMP. THE DRAINAGE BAG WAS LEVELED TO 10CM ABOVE THE EAM AND THE DRAINAGE BAG SLIPPED DOWN THE MEASURING BAR TO THE LOWEST POINT POSSIBLE, NEGATIVE 9 CM. WHEN THE BAG SLIPPED, THERE WAS AN OVER DRAINAGE OF CEREBROSPINAL FLUID AGAIN. WHEN THE BAG WAS ADJUSTED TO THE PROPER LEVEL, AND THE SCREW WAS TIGHTENED BY 3 NURSES TO ENSURE IT WAS SECURE, IT COULD BE VISUALIZED THAT THE DRAINAGE BAG WAS SLIDING SLOWLY DOWN THE MEASURING BAR AGAIN. THE CUSTOMER HAD BEEN USING THESE POLE REPEATEDLY FOR TWO YEARS, AS HAVE THE HIGHEST USAGE OF THE POLE MOUNTS IN THE HOSPITAL. THIS WOULD APPEAR TO BE A REPETITIVE USE PROBLEM. THE MALE PHYSICIAN ASSISTANT USED GREATER FORCE ON THE DEFECTIVE POLE MOUNT AND HE MANAGED TO TIGHTENED THE SCREW SO IT NO LONGER SLIPPED. IT TOOK SO MUCH FORCE THEY OBTAINED ANOTHER POLE MOUNT, CHECKED THOSE SCREWS FOR TIGHTNESS AND HAD NO FURTHER ISSUES. THE CUSTOMER SEQUESTERED THAT FIRST MOUNT AS A SAFETY MEASURE FOR THE COMPANY. INVESTIGATION COMPLETED 15NOV2017: NO LOT NUMBER WAS REPORTED AND THEREFORE NO DHR REVIEW WAS POSSIBLE. UPON REVIEW OF INTEGRA'S COMPLAINT SYSTEM FROM SEPTEMBER 2015 TO SEPTEMBER 2017, THERE IS NO OTHER COMPLAINT FOUND RELATED TO THE SLIDING ADAPTER BEING PULLED DOWN BY THE WEIGHT OF THE DRAIN BAG. THE COMPLAINT OCCURRENCE RATE FOR THIS TYPE OF INCIDENT IS THEN (B)(4). THE UNIT RETURNED WAS EVALUATED AND IT WAS FOUND TO BE IN GOOD CONDITION. THE UNIT WAS TESTED TO EVALUATE THE CLAIM THAT THE WEIGHT OF THE DRAINAGE BAG PULLED THE SLIDING ADAPTER DOWN. A FULL 500 ML DRAIN BAG WOULD WEIGHT A LITTLE OVER 1 LB. THE UNIT WAS TESTED WITH 10 LB. THE TEST DID NOT CONFIRM THE CLAIM SINCE THE DEVICE TIGHTENED WITHOUT THE NEED OF EXCESSIVE FORCE AND WAS ABLE TO HOLD 10 LB. THE CONDITION COULD NOT BE DUPLICATED, THE COMPLAINT COULD NOT BE CONFIRMED.

    Description of Event or Problem · 1

    THE SMALLER CLAMP WAS TIGHTENED AS MUCH AS POSSIBLE AND WEIGHT OF THE DRAINAGE BAG PULLED IT DOWN ON THE POLE. IT WAS SUPPOSED TO BE AT 10 CM ABOVE THE ORIENTATION POINT AND ¿FELL¿ TO NEGATIVE 9 BELOW EXTERNAL AUDITORY MEATUS (EAM). THE EXTERNAL VENTRICULOSTOMY DRAIN (EVD) RESULTED IN A 50 CC VENTING OF CEREBRO SPINAL FLUID IN A TWO HOUR PERIOD UNTIL THE NURSE NOTICED IT. THE PATIENT WAS CLINICALLY FINE. THE PHYSICIAN WAS NOTIFIED AND EXAMINED THE PATIENT. NO HEAD CT WAS REQUIRED AFTER SPEAKING WITH THE SURGEONS. THE EVD WAS THEN RAISED TO 10CM ABOVE THE EAM AND THE DEVICE WAS IMMEDIATELY SEEN SLIDING DOWN THE LUMBAR DRAIN POLE. MULTIPLE ATTEMPTS WERE MADE TO TIGHTEN THE SCREW ON THE POLE WITHOUT SUCCESS. THE POLE MOUNT CHANGED OUT AND NO ISSUE WAS SEEN. UPON FURTHER EXAMINATION, THE CLAMP WAS ¿FORCED¿ AND TWISTED VERY HARD BY THE MALE PHYSICIAN ASSISTANT, IT WAS THEN WORKING PROPERLY. IT WAS REPORTED THAT THREE PEOPLE TRIED TO TIGHTEN IT AND IT STILL SLID DOWN THE POLE. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    680040 POLE MOUNT ASSEMBLY N/A JXG INTEGRA NEUROSCIENCES PR

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR