BEUDAMED
    FDA Adverse Event Death Summary report: N

    ACCUDRAIN WITH ANTI-REFLUX VALVE

    MDR report key: 6122817 · Received November 22, 2016

    Report

    Report Number
    2648988-2016-00056
    Event Type
    Death
    Date Received
    November 22, 2016
    Date of Event
    November 4, 2016
    Report Date
    November 4, 2016
    Manufacturer
    INTEGRA NEUROSCIENCES PR
    Product Code
    JXG
    PMA / PMN Number
    K042825
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION RECEIVED ON 26JAN2017: THE CUSTOMER REPORTED THAT FOR ICU PATIENTS WITH A HUMMINGBIRD OR EVD (DRAIN), COLLODION REMOVER OR ACETONE IS USED TO REMOVE THE COLLODION GEL THAT IS USED TO GLUE ELECTROENCEPHALOGRAM (EEG) LEADS (ELECTRODES) TO A PATIENT¿S HEAD. WHEN ANY OF THESE SUBSTANCES COME IN CONTACT WITH THE STOPCOCK, THEY CAUSE IT TO CRACK WITHIN SECONDS OF APPLYING. THEY TRIED THE SAME THING WITH ACETONE AND IT TOOK A LITTLE LONGER BUT EVENTUALLY IT CRACKED AND BROKE IN HALF. THE CUSTOMER STATED SHE REVIEWED THE PICTURES OF THE CRACKS IN THE DRAIN SHE SENT BACK FOR EVALUATION AND THE DRAIN THEY HAD USED TO TEST THE SOLUTIONS AND THEY LOOKED IDENTICAL. SHE BELIEVED THAT THERE WAS NOT A DEFECT IN THE DRAIN BUT RATHER AN OBVIOUS INCOMPATIBILITY WITH THE MATERIALS OF THE DRAIN AND COLLODION REMOVER AND/OR ACETONE. IT WAS BELIEVED THE SUBSTANCE ENDED UP ON THE DRAIN BECAUSE OF THE WAY THE DRAIN IS SECURED TO THE PATIENT'S SHOULDER AND THE EEG THAT COMPLETELY COVERS THE SCALP AND SIDE OF THE FACE WHICH CAUSES THE TWO TO BE WITHIN CLOSE PROXIMITY. THE EEG TEAM AT UNIVERSITY OF NEW MEXICO WILL NOW BE TRIALING A DIFFERENT METHOD OF GLUING THE EEG LEADS THAT IS SUPPOSED TO BE REMOVABLE WITH SOAP AND WATER/WATERLESS SHAMPOO. THEY STATED THE NEED TO DISCONTINUE USE OF COLLODION REMOVER AND ACETONE IN THE ICU FOR PATIENTS WITH A HUMMINGBIRD OR EVD (DRAIN) OF THE BRAIN IMMEDIATELY. INTEGRA HAS COMPLETED THEIR INTERNAL INVESTIGATION ON 03FEB2017. THE INVESTIGATION INCLUDED: METHODS: -EVALUATION OF ACTUAL DEVICE -REVIEW OF DEVICE HISTORY RECORDS. -REVIEW OF COMPLAINT HISTORY. RESULTS: EVALUATION OF DEVICE: ONE ACCUDRAIN UNIT, LOT 1162325 WAS RECEIVED WITH A TRANSDUCER ATTACHED TO THE LOWER HANDLE MOUNT STOPCOCK. THE LOWER HANDLE MOUNT STOPCOCK WAS DETACHED FROM THE HANDLE MOUNT. SINCE THE TRANSDUCER WAS ATTACHED TO THE STOPCOCK, IT MAY HAVE BEEN DETACHED DURING TRANSIT AS IT WAS A TIGHT FIT INSIDE THE PACKAGE DELIVERED. UPON EXAMINATION EVIDENCE OF ADHESIVE RESIDUES WERE SEEN. THE STOPCOCK IN THE PATIENT LINE WAS BROKEN. TEST PERFORMED: A TEST WAS PERFORMED TO TRY TO DUPLICATE THE DEFECT USING A DIFFERENT LOT NUMBER SINCE STOPCOCK LOT 3152879, USED IN ACCUDRAIN LOT 1162325, WAS DEPLETED. THE STOPCOCK LOT USED FOR THE TEST WAS 3154003. THE TEST CONSISTED OF APPLYING STRESS TO THREE (3) STOPCOCKS BY MEANS OF A PAIR OF PLIERS. THE DEFECT (CRACKS) COULD NOT BE REPRODUCED. THE MANUFACTURING AND FINAL PACK PROCESSES RAN NORMALLY; NO ANOMALIES WERE FOUND DURING MANUFACTURING PROCESS OF THE PRODUCT. THIS LOT WAS RELEASED ON JUNE 28, 2016. ALL UNITS (100%) ARE LEAK AND OCCLUSION TESTED PER TM 1021 (ACCUDRAIN PRODUCTS FUNCTIONAL TEST). NO UNIT WAS REJECTED DURING THIS OPERATION. STOPCOCK LOT USED FOR THIS LOT WAS 3152879 (P/N 200407-001). AS PART OF STOPCOCK INCOMING RELEASE, THE LOT IS VERIFIED 100% FOR CRACKS AND STRESS MARKS UNDER A MICROSCOPE 3X AS PER TM-1059 (VISUAL INSPECTION OF 4-WAY STOPCOCK). AFTER THE 100% INSPECTION PERFORMED BY TRAINED MANUFACTURING PERSONNEL, QA SAMPLES AND INSPECTS 299 UNITS. INCOMING RECORDS FOR THE STOPCOCK WERE REVIEWED AND THEY WERE FOUND TO MEET CURRENT REQUIREMENTS. UPON REVIEW OF INTEGRA'S COMPLAINT SYSTEM FROM NOVEMBER 2014 TO NOVEMBER 2016, THERE ARE FOUR (4) COMPLAINTS RELATED TO ¿CRACKED STOPCOCK & LEAKAGE¿ INCLUDING THIS ONE. THIS LOT NUMBER (1162325) HAS NOT BEEN REPORTED IN ANY OTHER COMPLAINT. (B)(4). CONCLUSION: ORIGINALLY, IT WAS CONCLUDED THAT THERE ARE CONTROLS AT INTEGRA TO DETECT THIS DEFECT AND THAT NO MANUFACTURING EVENT WAS NOTICED THAT COULD PROVOKE STOPCOCK BREAKAGE. IT WAS ALSO STATED THAT THE DEVICE SET-UP, HANDLING, OR CIRCUMSTANCES SURROUNDING BREAKAGE OF THE DEVICE WERE NOT EXPLAINED IN THESE COMPLAINTS OR THE AMOUNT OF TIME IN USE PRIOR TO BREAKAGE. IN THREE (3) OUT OF THE FOUR (4) COMPLAINTS, THE FAILURE WAS REPORTED TO HAPPEN WHILE IN USE, NOT BROKEN WHEN ORIGINALLY PLACED; THE OTHER ONE WAS NOT EXPLICIT. IT WAS ALSO NOTICED THAT TRENDING DID NOT SHOW THAT THERE WAS A SPIKE IN STOPCOCK BREAKAGE IN THE MARKET AND THUS SEEMED TO BE ISOLATED TO THE (B)(6) HOSPITAL AND THAT THESE BREAKAGES COULD HAVE BEEN PROVOKED BY SOME INTERNAL PRACTICE OR HANDLING OF THE DEVICE. NEW INFORMATION WAS SHARED STATING THAT COLLODION REMOVER OR ACETONE IS USED TO REMOVE THE COLLODION GEL THAT IS USED TO GLUE ELECTROENCEPHALOGRAM (EEG) LEADS (ELECTRODES) TO A PATIENT¿S HEAD. WHEN ANY OF THESE SUBSTANCES COME IN CONTACT WITH THE STOPCOCK, THEY CAUSE IT TO CRACK. THEREFORE THE ORIGINAL CONCLUSION REGARDING THAT MOST PROBABLE CAUSE COULD BE LINKED TO SOME INTERNAL HOSPITAL PRACTICE WAS ACCURATE.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED ON 12/21/2016: THE PATIENT WAS DECLARED BRAIN DEAD AFTER HERNIATION AND PROCEEDED TO BECOME AN ORGAN DONOR. THE DATE OF INSERTION OF THE DEVICE WAS (B)(6) 2016 AND DATE OF EXPLANT (B)(6) 2016. THE REASON FOR THE DEVICE PLACEMENT WAS FOR INTRACRANIAL HEMORRHAGE (ICH) WITH INTRAVENTRICULAR EXTENSION. THE ORIGINAL EV AND TRAUMACATH WAS REMOVED AND A SECOND TRAUMACATH AND ACCUDRAIN PLACED NOT ONLY BECAUSE OF LEAKING BUT ALSO BECAUSE THE SYSTEM WAS BLOODY AND NOT PATENT (MOST LIKELY DUE TO A BLOOD CLOT) AND WE WERE NOT ABLE TO DRAIN THE CEREBROSPINAL FLUID (CSF). THERE WAS NOT ANY PATIENT HARM THAT WAS DIRECTLY RELATED TO THE LEAKING OF THE ACCUDRAIN. THE PATIENT DID ULTIMATELY PASS FROM HERNIATION. IT WAS UNCERTAIN HOW MUCH CSF LOSS THERE WAS SINCE IT WAS FOUND TO BE ABSORBED INTO THE LINENS OF THE HOSPITAL BED. THE TRANSDUCER NEVER FELL OFF OR BECAME DISCONNECTED, BUT RATHER THE DRAIN CRACKED IN THE HOUSING OF THE STOP COCK PROXIMAL TO THE PATIENT.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED ON 12/21/2016: THE DATE OF BRAIN DEATH TESTING AND DECLARATION WAS (B)(6) 2016. TIME OF DEATH WAS NOT KNOWN. THE PATIENT BECAME AN ORGAN DONOR AND THE FAMILY DECLINED AUTOPSY. THE CAUSE OF DEATH WAS INTRACEREBRAL HEMORRHAGE WITH INTRAVENTRICULAR EXTENSION.

    Description of Event or Problem · 1

    ON (B)(6) 2016 THE INS8401 ACCUDRAIN WITH ANTI-REFLUX VALVE WAS LEAKING FROM THE PROXIMAL STOPCOCK. THE DEVICE WAS IN USE ON A FEMALE PATIENT. THERE WERE CRACKS UNDERNEATH THE STOPCOCK THAT WAS PROXIMAL TO THE PATIENT. THE DEVICE WAS REPLACED WITH ANOTHER ACCUDRAIN. IT WAS UNKNOWN IF THERE WAS PATIENT INJURY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    771222 ACCUDRAIN WITH ANTI-REFLUX VALVE N/A JXG INTEGRA NEUROSCIENCES PR 1162325

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| R