BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    (CAMINO) OLM INTRACRANIAL PRESSURE MONITORING KIT

    MDR report key: 7444531 · Received April 19, 2018

    Report

    Report Number
    2023988-2018-00014
    Event Type
    Malfunction
    Date Received
    April 19, 2018
    Report Date
    April 19, 2018
    Manufacturer
    NATUS MEDICAL INC. DBA INTEGRA NEUROSCIENCES
    Product Code
    GWM
    UDI-DI
    10381780023623
    PMA / PMN Number
    K102875
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: NO PATIENT INJURY. FOUR ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION ON THIS INCIDENT, HOWEVER THERE HAS BEEN NO RESPONSE: ADDITIONAL INFORMATION REQUESTED: 04APRIL2018-NO RESPONSE. ADDITIONAL INFORMATION REQUESTED: 19APRIL2018-NO RESPONSE. ADDITIONAL INFORMATION REQUESTED: 02MAY2018-NO RESPONSE. ADDITIONAL INFORMATION REQUESTED 15MAY2018- NO RESPONSE. NATUS COMPLETED THEIR INVESTIGATION ON (B)(6) 2018. THE RESULTS INCLUDED THE REFERENCE: DEVICE HISTORY RECORD REVIEW. REVIEW OF PAST CAPAS/ CAPA DETERMINATION. REVIEW OF COMPLAINTS HISTORY/TREND ANALYSIS. RISK MANAGEMENT REVIEW. RESULTS: THE DEVICE HISTORY RECORD FOR THE CATHETER WAS REVIEWED, THERE WERE NO ANOMALIES OBSERVED DURING THE MANUFACTURING, PACKAGING OR INSPECTION OF THE DEVICE OR ACCESSORIES WHILE IN PROCESS. CAPA COMPLAINT LOG 201 6, 2017 REVIEWED ON 07-APR-2018 SPECIFIC FOR THE COMPLAINT ISSUE UNDER INVESTIGATION INDICATES THAT THERE NO CAPA INVESTIGATION RELATED TO THIS CATHETER COMPLAINT. NO CAPA HAS BEEN ISSUED IN 2018. THERE WERE TWELVE (12) CONFIRMED COMPLAINT DURING APR-2016 THROUGH MAR-2018 UNDER COMPLAINT CODE "INTEGIMPROPER FUNCTION". THE NUMBERS OF CATHETER SOLD DURING THIS TIME, (81036) SHOWS AN INCIDENCE RATE OF 0.015%. THE FAILURE MODE RESULTED IN A "DELAY IN PATIENT TREATMENT" (IDS-B-BT-L-OOI ). A REVIEW OF THE CAMINO RISK MANAGEMENT FILE HAS IDENTIFIED THE FAILURE MODE OF "DOES NOT MEASURE INTRACRANIAL PRESSURE ACCURATELY" (IDS-B-BT-L-OOI ), THIS IS BASED ON THE COMPLAINT DESCRIPTION. IT CAN BE CONCLUDED THAT THE IMPACT OF THE FAILURE OF THE 110-4BT CATHETER RESULTED IN A "DELAY IN PATIENT TREATMENT" (IDS-B-BT-L-OOI ).: THE REPORTED CUSTOMER COMPLAINT COULD NOT BE REPLICATED. ROOT CAUSE: BASED ON THE RESULTS OF THIS INVESTIGATION, THE ROOT CAUSE OF THE REPORTED CUSTOMER COMPLAINT COULD NOT BE DETERMINED AT THIS TIME. NO CORRECTIVE ACTION REQUIRED BASED ON THE EVALUATION ABOVE. TRENDS WILL BE MONITORED FOR THIS OR SIMILAR COMPLAINTS. MULTIPLE ATTEMPES WERE MADE TO OBTAIN ADDITIONAL INFORMATION FROM THE CUSTOMER, HOWEVER THERE HAS BEEN NO RESPONSE. THIS COMPLAINT IS NOW DEEMED CLOSED, SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE COMPLAINT MAY BE REOPENED.

    Description of Event or Problem · 1

    THE FOLLOWING WAS REPORTED BY A FOREIGN USER FACILITY: "THE HOSPITAL INFORMED THE CATHETER STOPPED THE MEASUREMENT DURING THE USE" ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    287290 (CAMINO) OLM INTRACRANIAL PRESSURE MONITORING KIT INTRACRANIAL PRESSURE MONITORING DEVICE GWM NATUS MEDICAL INC. DBA INTEGRA NEUROSCIENCES 110-4B 266190-B09 10381780023623

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention