BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CSF DRAINAGE SYSTEM USED WITH POLE MOUNT SYSTEM

    MDR report key: 7453736 · Received April 24, 2018

    Report

    Report Number
    2648988-2018-00018
    Event Type
    Injury
    Date Received
    April 24, 2018
    Report Date
    April 4, 2018
    Manufacturer
    INTEGRA NEUROSCIENCES PR
    Product Code
    JXG
    PMA / PMN Number
    K920156
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED FOR EVALUATION. ALONG WITH THE EVD UNIT THERE WAS A TRANSDUCER OF UNKNOWN MANUFACTURER (THERE ARE NO MARKINGS ON THE TRANSDUCER); ALSO, ATTACHED TO THE TRANSDUCER THERE WAS AN IV BAG. THE MONITOR¿S LOT NUMBER COULD NOT BE CONFIRMED BECAUSE THE LABEL WAS DAMAGED. BY VISUAL INSPECTION, IT COULD BE CONFIRMED THAT THE ¿MANIFOLD STOPCOCK¿ WAS BROKEN. THE STOPCOCK¿S CONNECTION PART WAS BROKEN-OFF FROM THE STOPCOCK¿S MAIN BODY. THE STOPCOCK¿S CONNECTION PART WAS FOUND ATTACHED TO THE TRANSDUCER LUER LOCK. NO OTHER BROKEN PARTS WERE OBSERVED ON THE DEVICE. THE DHR FOR LOT 1173462 WAS REVIEWED. ALL IN-PROCESS CONTROLS WERE PERFORMED AS PER APPLICABLE PROCEDURES (INCLUDING LEAK TESTS TO ALL UNITS). NO ANOMALIES WERE FOUND TO INDICATE PRODUCT FAILURE DUE TO MANUFACTURING PROCESS OR MANUFACTURING COMPONENTS. NO REJECTS WERE OBSERVED. NO QUALITY EVENT AND/OR NON-CONFORMANCE WAS GENERATED FOR THE MENTIONED LOT; THEREFORE, THE LOT COMPLIED WITH ALL IN-PROCESS INSPECTIONS AND TESTING REQUIREMENTS AS SPECIFIED IN THE MANUFACTURING SHOP ORDER AND RELATED PROCEDURES. THE COMPLAINT IS CONFIRMED. AT THIS MOMENT, NO ROOT CAUSE HAS BEEN IDENTIFIED. (B)(4).

    Description of Event or Problem · 0

    N/A

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT YET RETURNED TO THE MANUFACTURER FOR ANALYSIS. THE PLANT INVESTIGATION IS IN PROGRESS AND A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 1

    GIVEN THAT COMPLAINT UNIT WAS NOT RETURNED FOR EVALUATION, THE REPORTED CONDITION COULD NOT BE CONFIRMED AND NO FURTHER ANALYSIS IS POSSIBLE. DHR REVIEW SHOWED THAT INTERNAL CONTROLS ARE IN PLACE AND ALL UNITS (100%) COMPLIED WITH LEAK TEST PERFORMED. NO MANUFACTURING ERROR WAS OBSERVED THAT COULD CAUSE THE REPORTED EVENT. NO ASSIGNABLE CAUSES THAT COULD BE ASSOCIATED TO THE MANUFACTURING AND/OR PACKAGING PROCESS AT INTEGRA, AÑASCO WERE DETERMINED BASED ON THE DHR REVIEW. FAILURE ANALYSIS IS NOT POSSIBLE AT THIS MOMENT BECAUSE THERE ARE NO RETURNED UNITS FOR EVALUATION.

    Description of Event or Problem · 1

    AN INTENSIVE CARE UNIT DIRECTOR REPORTED TO INTEGRA'S SALES REPRESENTATIVE THAT ON AN UNSPECIFIED DATE, THE TRANSDUCER ATTACHMENT ON THE 10-110 CSF DRAINAGE SYSTEM USED WITH POLE MOUNT SYSTEM HAD CRACKED. THE PATIENT HAS HAD THE DEVICE FOR SEVERAL DAYS. NO PATIENT INJURY WAS REPORTED, HOWEVER LEAKING OF CEREBROSPINAL FLUID (CSF) WAS NOTED. ADDITIONAL INFORMATION RECEIVED ON 09APR2018 INDICATING THAT THE REGISTERED NURSE WAS MONITORING THE PATIENT'S INTRACRANIAL PRESSURE (ICP) AND AMOUNT OF CSF DRAINAGE EVERY HOUR WHEN THE BROKEN CONNECTION WAS NOTED. ABOUT TEN MILLILITER (ML) OF CSF LEAK WAS SEEN ON THE FLOOR. THE EXTERNAL VENTRICULAR DRAIN (EVD) WAS REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    296199 CSF DRAINAGE SYSTEM USED WITH POLE MOUNT SYSTEM N/A JXG INTEGRA NEUROSCIENCES PR 1173462

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R