BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MODEL 3000 - 30ML VOLUME, HIG

    MDR report key: 9732114 · Received February 20, 2020

    Report

    Report Number
    1226348-2020-00011
    Event Type
    Injury
    Date Received
    February 20, 2020
    Date of Event
    December 1, 2019
    Report Date
    January 31, 2020
    Manufacturer
    CODMAN AND SHURTLEFF, INC
    Product Code
    LKK
    UDI-DI
    10886704043591
    PMA / PMN Number
    P890055
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    SAMPLE RECEIVED FOR EVALUATION: DHR - PRODUCT CODE NS9008 WITH LOT 3276920, CONFORMED TO THE SPECIFICATIONS WHEN RELEASED TO STOCK ON THE (B)(6) 2018. EXPIRATION DATE OCTOBER, 31 2023. FAILURE ANALYSIS: THE VALVE WAS VISUALLY INSPECTED, NO DEFECTS NOTED. THE VALVE PASSED THE TESTS FOR PROGRAMMING, OCCLUSIONS, LEAKS, REFLUX, SIPHON GUARD AND PRESSURE. NO ROOT CAUSE COULD BE DETERMINED, AS THE TECHNICIAN WAS UNABLE TO CONFIRM THE PROBLEM REPORTED BY THE CUSTOMER AT THE TIME OF INVESTIGATION. BETWEEN 05NOV2019 AND 30JUN2020, APPROXIMATELY 2,200 MDRS SUBMITTED ELECTRONICALLY BY INTEGRA LIFESCIENCES VIA TRACKWISE, INTEGRA'S COMPLAINT HANDLING SYSTEM, WERE NOT RECEIVED BY CDRH DUE TO A COMPUTER SYSTEM ISSUE. WITHIN THIS TIME PERIOD, AN ERROR WITH INTEGRA'S MIDDLEWARE, WHICH FACILITATES COMMUNICATIONS BETWEEN TRACKWISE AND THE FDA SYSTEM, CAUSED THE COMPLAINT RECORDS TO CLOSE AND INDICATE WE HAD RECEIVED AN ACKNOWLEDGEMENT 3 FROM THE FDA WHEN WE HAD NOT. INTEGRA INTERPRETED THE ACKNOWLEDGEMENT AS A SUCCESSFUL SUBMISSION; HOWEVER, SUBSEQUENT INVESTIGATION REVEALED THE ACKNOWLEDGEMENT 3 RECEIVED WAS FROM OUR MIDDLEWARE AND NOT FROM THE FDA (THESE ACKNOWLEDGEMENTS HAVE BEEN RETAINED AS PART OF THE DOCUMENTATION OF THE MDR). THE MALFUNCTION WAS RELATED TO THE RELOCATION OF THE TRACKWISE APPLICATION TO A NEW DATA CENTER DURING THE TRANSITION OF INTEGRA'S CORPORATE HEADQUARTERS FROM PLAINSBORO, NJ TO PRINCETON, NJ. PREVIOUSLY, INTEGRA HAD BEEN SUCCESSFULLY RECEIVING ACKNOWLEDGEMENTS 1, 2, AND 3 FROM THE FDA, AND OUR RECORDS REFLECT THESE ACKNOWLEDGEMENTS, INCLUDING THE DATE AND TIME STAMPS. CAPA PR (B)(4) AND NC 20-011 HAVE BEEN OPENED BY INTEGRA TO FURTHER INVESTIGATE THE NONCONFORMANCE AND DEVELOP A CORRECTIVE ACTION PLAN. THE MIDDLEWARE ERROR HAS BEEN CORRECTED, AND INTEGRA HAS FILED MDRS SINCE THE CORRECTION AND VERIFIED THAT THE APPROPRIATE ACKNOWLEDGEMENTS HAVE BEEN RECEIVED FROM THE FDA. INTEGRA IS RESUBMITTING ALL IMPACTED MDR REPORTS FOR THE TIME PERIOD 05NOV2019 THROUGH 30JUN2020. INTEGRA LIFESCIENCES CONTACTED (B)(6), DIRECTOR OF REGULATORY PROGRAMS, OFFICE OF PRODUCT EVALUATION AND QUALITY AND (B)(6), ASSISTANT DIRECTOR, MDR TEAM, OFFICE OF PRODUCT EVALUATION AND QUALITY ON JULY 8-9, 2020 TO REPORT THESE ISSUES REGARDING MDR REPORTS.

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (B)(4). INFORMATION REGARDING PATIENT WEIGHT, HEIGHT, MEDICAL HISTORY, RACE, AND ETHNICITY WAS NOT REPORTED. DATE OF EVENT: THE EVENT OCCURRED IN (B)(6) 2019; HOWEVER, THE EXACT DATE OF THE EVENT WAS NOT REPORTED. (B)(4). INFORMATION REGARDING PATIENT WEIGHT, HEIGHT, MEDICAL HISTORY, RACE, AND ETHNICITY WAS NOT REPORTED. MISSING INFORMATION FROM THIS REPORT IS IDENTIFIED AS BLANK; THIS INFORMATION WAS NOT PROVIDED IN THE REPORTED EVENT OR AVAILABLE AT THE TIME OF REPORT SUBMISSION. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF NEW FACTS ARISE WHICH MATERIALLY ALTER INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT. COMPLAINT CONCLUSION: A REPORT FROM THE FIELD INDICATED THAT THE CODMAN 3000 30ML (AP03000H/C19731/15445) CONSTANT FLOW IMPLANTABLE DRUG PUMP ONLY DELIVERED 4ML OF CHEMOTHERAPY DURING THE FIRST TWO-WEEK CYCLE AND 1ML DURING THE NEXT CYCLE. THE CATHETER WAS EASILY FLUSHED USING THE SPECIAL BOLUS NEEDLE, INDICATING THERE WAS NO CLOTTING OF THE CATHETER. THE REPORTING CLINICAL SPECIALIST INSTRUCTED THE SITE TO RINSE THE PUMP TWICE WITH INJECTABLE SALINE THE NEXT TIME THE PATIENT IS IN THE OFFICE TO DETERMINE IF THE FLOW ISSUE HAS RESOLVED. THE PUMP WAS IMPLANTED IN (B)(6) 2017. THE PATIENT INITIALLY RECEIVED SIX CYCLES OF CHEMOTHERAPY AND THEN GLYCERIN WAS PLACED IN THE PUMP UNTIL (B)(6) 2019. WHEN THE SITE RESTARTED THE CHEMOTHERAPY, THE PUMP ONLY DELIVERED 4ML DURING THE FIRST TWO-WEEK CYCLE AND THEN 1ML DURING THE FOLLOWING CYCLE. ADDITIONAL INFORMATION RECEIVED ON 10-FEB-2020 INDICATED THAT THE ISSUE STARTED IN (B)(6) 2019 WHEN THEY RESTARTED CHEMOTHERAPY AFTER DELIVERING GLYCEROL FOR TWO YEARS FOLLOWING SIX INITIAL CYCLES OF CHEMOTHERAPY. THE PATIENT ONLY RECEIVED 0.43ML OF DRUG PER DAY WHEN SHE WAS SUPPOSED TO RECEIVE 1.2ML PER DAY. IT WAS REPORTED THAT THE LAST REFILL PROCEDURE WAS PERFORMED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THE PATIENT DID NOT EXPERIENCE ANY CLINICAL SYMPTOMS AS A RESULT OF THE EVENT. THE PUMP DID NOT APPEAR DAMAGED. THE PUMP WAS REFILLED ON (B)(6) 2020 AND THE NEXT PLANNED REFILL IS ON (B)(6) 2020. THERE WAS NO EVIDENCE OF BUBBLES IN THE RESERVOIR. THE PUMP REMAINS IMPLANTED IN THE PATIENT. ADDITIONAL INFORMATION RECEIVED ON 19-FEB-2020 INDICATED THAT DURING THE LAST REFILL ON (B)(6) 2020, THE PUMP WAS REFILLED AND FLUSHED BUT THE PATIENT IS STILL RECEIVING LESS CHEMOTHERAPY DRUG THAN INTENDED. THE NEXT REFILL IS SCHEDULED FOR (B)(6) 2020. THE PUMP REMAINS IMPLANTED AT THIS TIME AND IS STILL IN USE; IT'S JUST NOT INFUSING AS MUCH DRUG AS IT SHOULD BE. THE CLINICAL ACCOUNT SPECIALIST IS WAITING TO HEAR BACK FROM THE SITE REGARDING THE OUTCOME. THE MODEL 3000 - 30ML VOLUME, HIGH, SERIAL # (B)(4) WAS NOT RETURNED FOR INVESTIGATION AS IT REMAINS IMPLANTED. A REVIEW OF MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT PRESENTED NO ISSUES DURING THE MANUFACTURING OR INSPECTION PROCESSES RELATED TO THE REPORTED COMPLAINT. VARIATION IN PUMP FLOW RATE WITH ASSOCIATED UNDERINFUSION OF DRUG IS A KNOWN POTENTIAL COMPLICATION ASSOCIATED WITH THE CODMAN 3000 PUMP. THE CODMAN 3000 IS A PROPELLANT-DRIVEN CONSTANT FLOW PUMP THAT IS DESIGNED TO DELIVER A CONTINUOUS INFUSION OF DRUG INTO THE INTRATHECAL SPACE. THE PUMP DELIVERS INFUSATE AT A PRESET FLOW RATE AND IS IDEALLY SUITED FOR THE AMBULATORY PATIENT. THE ROOT CAUSE OF THE EVENT CANNOT BE DETERMINED BASED ON THE MINIMAL INFORMATION PROVIDED; HOWEVER, POTENTIAL CAUSES INCLUDE LEAKAGE AND CHANGES IN BODY TEMPERATURE AND/OR AMBIENT PRESSURE. THE INSTRUCTIONS FOR USE (IFU) CAUTIONS THAT POST-IMPLANT PATIENTS MUST BE MONITORED CAREFULLY TO CONFIRM PROPER PUMP PERFORMANCE. IT ALSO STATES THAT IT IS IMPORTANT TO PRECISELY FOLLOW THE PUMP REFILL INSTRUCTIONS AS DETAILED IN THE PAMPHLET (OR THE PUMP REFILL KIT) TO SUCCESSFULLY COMPLETE THE PUMP REFILL PROCEDURE. THE FILE WILL BE RE-REVIEWED IF ADDITIONAL INFORMATION IS RECEIVED AT A LATER DATE. AS PART OF THE POST MARKET SURVEILLANCE PROGRAM, INFORMATION FROM THIS COMPLAINT IS TRENDED TO IDENTIFY STATISTICAL SIGNALS FOR CONSIDERATION OF FURTHER CORRECTION ACTION. SINCE THERE WAS NO EVIDENCE TO SUGGEST THE EVENT WAS RELATED TO A MANUFACTURING OR DESIGN ISSUE, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME.

    Description of Event or Problem · 1

    A REPORT FROM THE FIELD INDICATED THAT THE CODMAN 3000 30ML (AP03000H/C19731/15445) CONSTANT FLOW IMPLANTABLE DRUG PUMP ONLY DELIVERED 4ML OF CHEMOTHERAPY DURING THE FIRST TWO-WEEK CYCLE AND 1ML DURING THE NEXT CYCLE. THE CATHETER WAS EASILY FLUSHED USING THE SPECIAL BOLUS NEEDLE, INDICATING THERE WAS NO CLOTTING OF THE CATHETER. THE REPORTING CLINICAL SPECIALIST INSTRUCTED THE SITE TO RINSE THE PUMP TWICE WITH INJECTABLE SALINE THE NEXT TIME THE PATIENT IS IN THE OFFICE TO DETERMINE IF THE FLOW ISSUE HAS RESOLVED. THE PUMP WAS IMPLANTED IN (B)(6) 2017. THE PATIENT INITIALLY RECEIVED SIX CYCLES OF CHEMOTHERAPY AND THEN GLYCERIN WAS PLACED IN THE PUMP UNTIL (B)(6) 2019. WHEN THE SITE RESTARTED THE CHEMOTHERAPY, THE PUMP ONLY DELIVERED 4ML DURING THE FIRST TWO-WEEK CYCLE AND THEN 1ML DURING THE FOLLOWING CYCLE. ADDITIONAL INFORMATION RECEIVED ON 10-FEB-2020 INDICATED THAT THE ISSUE STARTED IN (B)(6) 2019 WHEN THEY RESTARTED CHEMOTHERAPY AFTER DELIVERING GLYCEROL FOR TWO YEARS FOLLOWING SIX INITIAL CYCLES OF CHEMOTHERAPY. THE PATIENT ONLY RECEIVED 0.43ML OF DRUG PER DAY WHEN SHE WAS SUPPOSED TO RECEIVE 1.2ML PER DAY. IT WAS REPORTED THAT THE LAST REFILL PROCEDURE WAS PERFORMED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THE PATIENT DID NOT EXPERIENCE ANY CLINICAL SYMPTOMS AS A RESULT OF THE EVENT. THE PUMP DID NOT APPEAR DAMAGED. THE PUMP WAS REFILLED ON (B)(6)2020 AND THE NEXT PLANNED REFILL IS ON (B)(6) 2020. THERE WAS NO EVIDENCE OF BUBBLES IN THE RESERVOIR. THE PUMP REMAINS IMPLANTED IN THE PATIENT. ADDITIONAL INFORMATION RECEIVED ON 19-FEB-2020 INDICATED THAT DURING THE LAST REFILL ON (B)(6) 2020, THE PUMP WAS REFILLED AND FLUSHED BUT THE PATIENT IS STILL RECEIVING LESS CHEMOTHERAPY DRUG THAN INTENDED. THE NEXT REFILL IS SCHEDULED FOR (B)(6) 2020. THE PUMP REMAINS IMPLANTED AT THIS TIME AND IS STILL IN USE; IT'S JUST NOT INFUSING AS MUCH DRUG AS IT SHOULD BE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    197547 MODEL 3000 - 30ML VOLUME, HIG CODMAN LKK CODMAN AND SHURTLEFF, INC AP-03000H C19731 10886704043591

    Patients

    Seq Age Sex Outcome Treatment
    1 Other