BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CSF DRAINAGE SYSTEM USED WITH POLE MOUNT SYSTEM

    MDR report key: 6388938 · Received March 8, 2017

    Report

    Report Number
    2648988-2017-00006
    Event Type
    Injury
    Date Received
    March 8, 2017
    Date of Event
    December 23, 2016
    Report Date
    February 14, 2017
    Manufacturer
    INTEGRA NEUROSCIENCES PR
    Product Code
    JXG
    PMA / PMN Number
    K920156
    Report Source
    Manufacturer report
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION COMPLETED 4/07/17. METHOD: DHR REVIEW; TREND ANALYSIS; EVALUATION OF VIDEO. THE CUSTOMER IDENTIFIED EXTERNAL VENTRICULAR DRAIN (EVD), LOT 1152568 / CATALOG 10-110 (MONITORR ICP EVD SYSTEM), AS THE PRODUCT INVOLVED IN THE EVENT; NONETHELESS, THE UNIT RECEIVED FROM THE CUSTOMER WAS DIFFERENT TO THE ONE REPORTED IN THE COMPLAINT. INSTEAD OF A MONITORR, AN ACCUDRAIN (LOT 1162324 / CATALOG INS-8400) WAS RECEIVED. AN ENCLOSED LETTER FROM CONNECTICUT CHILDREN¿S MEDICAL CENTER CLARIFIED THAT THE DEVICE SENT WAS THE ONE INVOLVED IN THE EVENT. THEREFORE, BOTH PRODUCTS (THE ONE REPORTED AND THE ONE RECEIVED) WERE EVALUATED AS PART OF THIS INVESTIGATION. LOT 1152568 - PRODUCT INFORMATION: MANUFACTURING (PACK) DATE: 07/17/15; EXPIRATION DATE: 06/2017. THE MONITORR ICP¿ EXTERNAL CSF DRAINAGE AND MONITORING SYSTEM IS DESIGNED TO PROVIDE A SIMPLE TO USE, CLOSED SYSTEM FOR THE DRAINAGE OF CEREBROSPINAL FLUID (CSF), AND ALLOWS FOR ACCURATE PRESSURE AND FLOW RATE MONITORING. DEVICE HISTORY RECORD (DHR) OF THE FINISH GOODS LOT # 1152568 WAS REVIEWED. NO ANOMALY OR DISCREPANCIES WERE REPORTED DURING THE MANUFACTURING OF THE FG LOT THAT COULD BE RELATED TO THE REPORTED CONDITION. LOT 1162324 - PRODUCT INFORMATION: MANUFACTURING (PACK) DATE: 06/13/16; EXPIRATION DATE: 05/31/18. THE ACCUDRAIN¿ EXTERNAL CSF DRAINAGE SYSTEM IS USED TO DRAIN CEREBROSPINAL FLUID (CSF) FROM THE VENTRICLES OF THE BRAIN OR THE LUMBAR SUBARACHNOID SPACE TO A DRAINAGE BAG. SYSTEM COMPONENTS FACILITATE CSF DRAINAGE, CSF SAMPLING AND INTRACRANIAL PRESSURE (ICP) MONITORING. MONITORING OF INTRACRANIAL PRESSURE (ICP) IS USUALLY PERFORMED IN SELECTED PATIENTS WITH SEVERE HEAD INJURY, SUBARACHNOID HEMORRHAGE, REYES SYNDROME OR SIMILAR ENCEPHALOPATHIES, HYDROCEPHALUS, HYDROCEPHALIC SHUNT INFECTIONS, INTRACRANIAL HEMORRHAGE AND PRE AND/OR POST-OPERATIVE MONITORING. DEVICE HISTORY RECORD (DHR) OF THE FINISH GOODS LOT # 1162324 WAS REVIEWED. NO ANOMALY OR DISCREPANCIES WERE REPORTED DURING THE MANUFACTURING OF THE FG LOT THAT COULD BE RELATED TO THE REPORTED CONDITION. REVIEW OF PRODUCT'S NCR, AND CAPA HISTORY FROM FEBRUARY 2015 - FEBRUARY 2017: NO RELATED NCR, CAPA, OR SCAR WAS OPENED DURING THE PERIOD OF FEBRUARY 2015 TO FEBRUARY 2017. REVIEW OF PRODUCT'S COMPLAINT HISTORY FROM FEBRUARY 2015 - FEBRUARY 2017: PRODUCT IMPACT ASSESSMENT FOR REPORTED DEVICE - MONITORR 10-110 / LOT 1152568: UPON REVIEW OF INTEGRA'S COMPLAINT SYSTEM FROM FEBRUARY 2015 - FEBRUARY 2017, THERE HAVE BEEN ONE (1) COMPLAINTS RELATED TO CSF LEAKAGE DUE TO DEFECTS ON THE BURETTE FOR THE MONITORR PRODUCT FAMILY. APPROXIMATELY (B)(4) UNITS HAVE BEEN RELEASED FOR DISTRIBUTION SINCE FEBRUARY 2015 ¿ FEBRUARY 2017, RESULTING IN A COMPLAINT OCCURRENCE RATE OF APPROXIMATELY (B)(4). BASED ON THE SEVERITY OF HARM AND LIKELIHOOD OF OCCURRENCE, THE RISK ASSOCIATED TO THE HAZARDOUS SITUATION IS DEEMED ACCEPTABLE. PRODUCT IMPACT ASSESSMENT FOR DEVICE RECEIVED - ACCUDRAIN INS-8400 / LOT 1162324: UPON REVIEW OF INTEGRA'S COMPLAINT SYSTEM FROM FEBRUARY 2015 - FEBRUARY 2017, THERE HAVE BEEN THREE (3) COMPLAINTS RELATED TO CSF LEAKAGE DUE TO DEFECTS ON THE BURETTE FOR THE ACCUDRAIN PRODUCT FAMILY. APPROXIMATELY (B)(4) UNITS HAVE BEEN RELEASED FOR DISTRIBUTION SINCE FEBRUARY 2015 ¿ FEBRUARY 2017, RESULTING IN A COMPLAINT OCCURRENCE RATE OF APPROXIMATELY (B)(4). BASED ON THE SEVERITY OF HARM AND LIKELIHOOD OF OCCURRENCE, THE RISK ASSOCIATED TO THE HAZARDOUS SITUATION IS DEEMED ACCEPTABLE. THE UNIT SENT WAS DIFFERENT FROM THE ONE REPORTED IN MEDWATCH (B)(4); NONETHELESS, AN ENCLOSED LETTER SPECIFIED THAT THIS WAS THE UNIT INVOLVED IN THE EVENT. THE UNIT RECEIVED WAS AN ACCUDRAIN INS8400 / LOT 1162324. THE UNIT WAS VISUALLY INSPECTED AND NO DEFECT WAS DETECTED AT PLAIN SIGHT. USING A 25CC SYRINGE, WATER WAS PASSED FROM THE NEEDLELESS PORT OF THE PATIENT LINE TO THE BURETTE. THE SYSTEM LEAKED WATER ON TOP PART OF THE BURETTE. PICTURES WERE TAKEN OF THE AREA WHERE THE LEAKAGE WAS OBSERVED, WHEN ENLARGED THESE REVEALED THAT THE PLASTIC CONNECTOR OF THE BURETTE¿S FILTER CAP TO THE PATIENT¿S LINE WAS PARTIALLY LIFTED FROM ONE SIDE. THE REPORTED CONDITION IS THEREFORE CONFIRMED. CONCLUSION: RETURNED UNIT INSPECTION REVEALED THAT THE FILTER CAP WAS PARTIALLY LIFTED ON ONE SIDE. THIS COULD BE A MANUFACTURING DEFECT OF THE MANUFACTURING COMPONENT PART NUMBER 20111-001 (FILTER CAP) WHICH WENT UNNOTICED DURING VISUAL INSPECTION. THE FILTER CAP USED IN THIS LOT WAS LOT 3152532 P/N 20111-001. THERE HAS NOT BEEN ANY OTHER COMPLAINT REPORTED TO ANY OF THESE (B)(4) LOTS RELATED TO THIS CONDITION; THUS, IT IS CONSIDERED AN ISOLATED CASE. NO MANUFACTURING FAILURE WAS FOUND IN THE DOCUMENTS REVIEWED AS PART OF THIS INVESTIGATION. THERE IS A LEAK TEST PERFORMED TO THE BURETTE ASSEMBLY, BUT SINCE IT IS A DESTRUCTIVE TEST, IT IS DONE ON 5 UNITS ONLY. THE TOP CAP IS VISUALLY INSPECTED, BUT AS STATED IN THE FAILURE ANALYSIS THE DEFECT WAS NOT AN OBVIOUS ONE. PROCESS CONTROLS ARE IN PLACE TO PREVENT OCCURRENCE AND DETECT THE REPORTED CONDITION. ONE HUNDRED % VISUAL INSPECTION OF BURETTE FILTER CAP COMPONENT BY MANUFACTURING PERSONNEL. LEAK TEST TO A SAMPLE OF UNITS. THE MOST PROBABLE CAUSE IS A DEFECTIVE MANUFACTURING COMPONENT THAT WENT UNNOTICED DURING VISUAL INSPECTION.

    Description of Event or Problem · 1

    AN EXTERNAL VENTRICULAR DRAIN (EVD) WAS BEING EMPTIED WHEN THE OUTER CHAMBER WAS NOTED TO BE WET. WHEN THE SYSTEM WAS CHANGED, IT WAS NOTED THAT THE TUBING ENTERING THE CHAMBER WAS NOT CONNECTED PROPERLY. ADDITIONAL INFORMATION WAS RECEIVED FROM THE CUSTOMER ON 28FEB2017: THE PATIENT HAD THE DRAINAGE SYSTEM FOR DRAINAGE AND MONITORING OF ICP. PATIENT HAD AN UNDERLYING MEDICAL CONDITION OF A BRAIN TUMOR. THE CUSTOMER REPORTED THAT THE TUBING WAS NOT CONNECTED PROPERLY; THE TUBING SHOULD HAVE BEEN SEALED INTO THE CHAMBER AND IT WAS NOT. THE CUSTOMER STATED THAT THERE WAS NO PATIENT INJURY DUE TO THE REPORTED ISSUE. HOWEVER, IT WAS REPORTED THAT CSF WAS DRAINING ON THE FLOOR INSTEAD OF INTO THE CHAMBER. THERE WAS A MINIMAL AMOUNT OF CSF THAT LEAKED. LINKED TO UF/IMPORTER REPORT# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    169877 CSF DRAINAGE SYSTEM USED WITH POLE MOUNT SYSTEM N/A JXG INTEGRA NEUROSCIENCES PR 1152568

    Patients

    Seq Age Sex Outcome Treatment
    1 5 YR Other