BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CSF DRAINAGE SYSTEM USED WITH POLE MOUNT SYSTEM

    MDR report key: 5160254 · Received October 20, 2015

    Report

    Report Number
    2648988-2015-00072
    Event Type
    Malfunction
    Date Received
    October 20, 2015
    Date of Event
    August 4, 2015
    Report Date
    September 25, 2015
    Manufacturer
    INTEGRA NEUROSCIENCES PR
    Product Code
    JXG
    PMA / PMN Number
    K022554
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INTEGRA HAS COMPLETED THEIR INTERNAL INVESTIGATION ON 01/19/2016 . THE INVESTIGATION INCLUDED: METHODS: EVALUATION OF ACTUAL DEVICE, REVIEW OF DEVICE HISTORY RECORDS, REVIEW OF COMPLAINTS HISTORY. RESULTS: DEVICE HISTORY RECORD (DHR) OF THE FINISH GOOD (FG) LOT # 1150095 WAS REVIEWED IN ORDER TO DETECT ANY ANOMALIES THAT COULD HAVE OCCURRED DURING THE MANUFACTURING PROCESS OF THE PRODUCT WHICH COULD HAVE CONTRIBUTED TO THE REPORTED INCIDENT. THE MANUFACTURING DATE IS 2015-01 AND THE EXPIRATION DATE IS 2016-12. THE FG LOT # 1150095 WAS RELEASED FOR DISTRIBUTION ON FEBRUARY 13, 2015 IN COMPLIANCE WITH THE PRODUCT SPECIFICATIONS AND INTEGRA REQUIREMENTS. NO ANOMALY OR DISCREPANCIES WERE REPORTED DURING THE MANUFACTURE OF THE FG LOT. A COMPLAINT HISTORY REVIEW WAS PERFORMED AND DOCUMENTED IN THE PRODUCT IMPACT ASSESSMENT. CAPA, NCR AND SCAR RECORDS WERE NOT REVIEWED AS PART OF THIS INVESTIGATION SINCE THE REPORTED EVENT IS NOT RELATED TO THE MANUFACTURING PROCESS OF THE PRODUCT. BASED ON THE INFORMATION PROVIDED BY THE CUSTOMER REGARDING PROPOFOL FOUND IN THE LUMBAR DRAIN TUBING, A SUMMARY OF THE PRODUCT¿S INSTRUCTIONS FOR USE (IFU) IS PROVIDED BELOW FOR FURTHER EVALUATION OF THE COMPLAINT. CONTRAINDICATIONS: ¿THE PRODUCT IS NOT DESIGNED, SOLD OR INTENDED FOR USE EXCEPT AS INDICATED. WARNINGS: ¿THIS PRODUCT HAS NOT BEEN TESTED FOR DRUG COMPATIBILITY AND THEREFORE IS NOT INTENDED FOR DRUG ADMINISTRATION. NO OTHER COMPLAINTS HAVE BEEN REPORTED FOR FG LOT # 1150095 RELATED TO ¿PROPOFOL FOUND IN THE LUMBAR DRAIN TUBING¿ OR ANY OTHER CONDITION. UPON REVIEW OF INTEGRA¿S COMPLAINT SYSTEM FROM JANUARY 2013 ¿ SEPTEMBER 2015, A TOTAL OF ONE (1) COMPLAINT (INVESTIGATED UNDER THIS REPORT) FOR MONITOR ICP EXTERNAL CSF DRAINAGE PRODUCT FAMILY HAS BEEN REPORTED REGARDING ¿PROPOFOL FOUND IN THE LUMBAR DRAIN TUBING¿. APPROXIMATELY (B)(4) UNITS HAVE BEEN SHIPPED FOR DISTRIBUTION FROM 2013 TO SEPTEMBER 18, 2015, RESULTING IN A COMPLAINT OCCURRENCE RATE OF (B)(4). CONCLUSION: THE COMPLAINT COULD NOT BE CONFIRMED GIVEN THAT THE COMPLAINT UNIT WAS NOT RETURNED FOR EVALUATION. BASED ON THE INFORMATION PROVIDED IN THE COMPLAINT RECORD, ¿PROPOFOL WAS INTENDED TO BE GIVEN VIA PERIPHERAL IV, RATHER THAN INTRATHECALLY¿, THE REPORTED INCIDENT IS NOT RELATED TO A FAILURE OR MALFUNCTION OF THE DEVICE. AS INDICATED IN THE PRODUCT¿S INSTRUCTIONS FOR USE, THE PRODUCT IS NOT DESIGNED, SOLD OR INTENDED FOR USE EXCEPT AS INDICATED, HAS NOT BEEN TESTED FOR DRUG COMPATIBILITY AND THEREFORE IS NOT INTENDED FOR DRUG ADMINISTRATION. PER PRODUCT DESIGN, THE GREEN STRIPED PATIENT LINE AND THE ¿CSF ACCESS¿ YELLOW LABEL PROXIMAL TO THE CSF NEEDLELESS PORT PROVIDE A VISUAL AID TO DIFFERENTIATE THE LINE FROM IV OR ANESTHESIA INFUSION TUBING.

    Description of Event or Problem · 1

    MEDWATCH UF/IMPORTER REPORT# (B)(4) WAS RECEIVED ON 25 SEP 2015 WITH THE FOLLOWING INFORMATION: DATE OF EVENT: (B)(6) 2015. DESCRIPTION OF EVENT: DURING THE SURGICAL PROCEDURE, A STAFF MEMBER OBSERVED PROPOFOL IN THE LUMBAR DRAIN TUBING. THE SURGERY WAS ABORTED IMMEDIATELY UPON THIS DISCOVERY. PROPOFOL WAS INTENDED TO BE GIVEN VIA PERIPHERAL IV RATHER THAN INTRATHECALLY. OTHER THERAPIES IN USE ON PATIENT: OTHER. OTHER DEVICES IN USE ON PATIENT: YES - THERE WERE MULTIPLE LINES, BUT FOR THIS EVENT WE ARE POINTING OUT A CSF DRAINAGE SYSTEM AND A BLOOD SET WITH 3 GANG STOPCOCK MANIFOLD. ADVERSE EVENT. DEATH, REQUIRED INTERVENTION TO PREVENT PERMANENT IMPAIRMENT/DAMAGE. ADDITIONAL INFORMATION AND CLARIFICATION WAS REQUESTED FROM THE CUSTOMER AND ON 28 SEP 2015 (VIA PHONE) AND 30 SEP 2015 (VIA EMAIL), IT WAS CONFIRMED BY THE CUSTOMER THAT THERE WAS NO PATIENT DEATH (AS REPORTED IN MEDWATCH UF/IMPORTER REPORT # (B)(4)). THERE WAS ALSO NO SERIOUS INJURY OR SERIOUS DISABILITY TO THE PATIENT. THE PATIENT IS ALIVE AND WELL. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    693681 CSF DRAINAGE SYSTEM USED WITH POLE MOUNT SYSTEM N/A JXG INTEGRA NEUROSCIENCES PR 1150095

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR