BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXACTA DRAINAGE SYSTEM, 100 ML

    MDR report key: 4164743 · Received October 10, 2014

    Report

    Report Number
    2021898-2014-00402
    Event Type
    Malfunction
    Date Received
    October 10, 2014
    Date of Event
    July 30, 2014
    Report Date
    September 10, 2014
    Manufacturer
    MEDTRONIC NEUROSURGERY
    Product Code
    GWM
    PMA / PMN Number
    K983799
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS UNAVAILABLE FOR RETURN. THEREFORE AN EVALUATION OF DEVICE PERFORMANCE WAS NOT POSSIBLE. A REVIEW OF THE MANUFACTURING RECORDS WAS NOT POSSIBLE AS NO LOT NUMBER WAS PROVIDED. THE INSTRUCTIONS FOR USE THAT ACCOMPANY THE DEVICE STATE THAT ¿ALL CONNECTIONS SHOULD BE FINGER TIGHTENED. OVER TIGHTENING CAN CAUSE CRACKS AND LEAKS TO OCCUR. LEAKAGE COULD RESULT IN COMPLICATIONS SUCH AS PATIENT INFECTION, UNDERDRAINAGE OR OVERDRAINAGE, AS WELL AS USER INFECTION.¿ ADDITIONAL DEVICE/PATIENT INFORMATION: IT WAS REPORTED TO MEDTRONIC NEUROSURGERY THAT THE PATIENT HAD BEEN DISCHARGED AND THERE WAS NO INJURY TO THE PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED TO MEDTRONIC NEUROSURGERY THAT THE CSF COLLECTION BAG ON THE EVD WAS BEING CHANGED PER PROCEDURE. ACCORDING TO THE REPORT, THE PATIENT¿S EVD WAS CLAMPED PER PROCEDURE. REPORTEDLY, THERE WAS DIFFICULTY IN UNSCREWING THE CONNECTION BETWEEN THE BURITROL AND THE COLLECTION BAG. THE REPORT STATED THAT THE CONNECTION SNAPPED CAUSING THE COLLECTION BAG TO FALL OFF AND THE BURITROL SYSTEM TO NEED TO BE REPLACED WHICH RESULTED IN THE PATIENT¿S EVD REMAINING CLAMPED FOR 5-10 MINUTES. ACCORDING TO THE REPORT, THE PATIENT BEGAN TO VOMIT AND BECAME UNRESPONSIVE. REPORTEDLY, THE RN ATTEMPTED TO AROUSE THE PATIENT WHILE WAITING FOR THE NEUROSURGERY RESIDENT TO COME AND RECONNECT THE DRAINAGE SYSTEM. THE REPORT STATED THAT CONDITION C (CODE CRITICAL) WAS INITIATED. ACCORDING TO THE REPORT, THE NEUROSURGERY RESIDENT ARRIVED TO THE PATIENT¿S BEDSIDE TO RECONNECT THE EVD DRAINAGE SYSTEM. REPORTEDLY, THE PATIENT BEGAN TO BECOME AROUSABLE ONCE THE DRAIN WAS UNCLAMPED BY THE DOCTOR. THE REPORT STATED THAT THERE WAS NO LASTING HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    640718 EXACTA DRAINAGE SYSTEM, 100 ML DEVICE, MONITORING, INTRACRANIAL PRESSURE GWM MEDTRONIC NEUROSURGERY UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 00019 YR Required Intervention