BEUDAMED
    FDA Adverse Event Death Summary report: N

    MODEL 3000 - 30ML VOLUME, HIG

    MDR report key: 8737551 · Received June 26, 2019

    Report

    Report Number
    1226348-2019-00915
    Event Type
    Death
    Date Received
    June 26, 2019
    Date of Event
    July 6, 2018
    Report Date
    June 4, 2019
    Manufacturer
    CODMAN AND SHURTLEFF, INC
    Product Code
    LKK
    UDI-DI
    10886704043591
    PMA / PMN Number
    P890055
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURER¿S REF. NO.: (B)(4). INFORMATION REGARDING PATIENT IDENTIFIER, PATIENT AGE, PATIENT WEIGHT, RACE, ETHNICITY, AND MEDICAL HISTORY WERE NOT PROVIDED. THE DATE OF DEATH WAS NOT REPORTED. (B)(4). [CONCLUSION]: THE EVENT WAS REPORTED AS A WRITTEN NOTE ON A PATIENT FOLLOW-UP LETTER BY THE PATIENT¿S SPOUSE. IT WAS REPORTED THAT THE 30ML HIG MODEL 3000 CODMAN CONSTANT FLOW IMPLANTABLE PUMP (AP03000H / LOT#: 15705) IMPLANTED IN THE PATIENT ON (B)(6) 2018 CAUSED AN ULCER IN THE PATIENT THAT RESULTED IN A MAJOR ARTERY PERFORATION. THE PUMP WAS EXPLANTED ON (B)(6) 2018. THE PATIENT UNDERWENT MAJOR SURGERY TO REPAIR THE DAMAGE FROM THE PUMP WHICH ULTIMATELY RESULTED IN THE DEATH OF THE PATIENT. NO OTHER INFORMATION WAS PROVIDED. THE CODMAN PUMP WAS NOT RETURNED FOR INVESTIGATION. A REVIEW OF MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT (15705) PRESENTED NO ISSUES DURING THE MANUFACTURING OR INSPECTION PROCESSES RELATED TO THE REPORTED COMPLAINT. THERE WERE NO NON-CONFORMANCES RELATED TO DEVICE MANUFACTURE OR INSPECTION. ALL PRODUCT REJECTED DURING MANUFACTURING WAS IDENTIFIED AS SCRAP AND PROPERLY ACCOUNTED FOR. PRODUCT ANALYSIS CANNOT BE CONDUCTED AS THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. NO DETERMINATION OF CAUSES AND POSSIBLE CONTRIBUTING FACTORS COULD BE MADE. AS SUCH, THE INVESTIGATION WILL BE CLOSED. PRODUCT INVESTIGATION WILL BE REOPENED IF THE PUMP IS RETURNED. TISSUE EROSION AND DEATH ARE KNOWN POTENTIAL COMPLICATIONS ASSOCIATED WITH THE CODMAN 3000 PUMP. THE ROOT CAUSE OF THE EVENT CANNOT BE CONCLUSIVELY DETERMINED AT THIS TIME BASED ON THE MINIMAL INFORMATION AVAILABLE FOR REVIEW; THEREFORE, ADDITIONAL INVESTIGATION IS REQUIRED TO DETERMINE THE SEQUENCE OF EVENTS LEADING UP TO THE ULCER, VESSEL PERFORATION, AND HIS EVENTUAL DEATH. THERE WAS NO REPORT OF ANY DIFFICULTY ENCOUNTERED DURING IMPLANTATION OF THE PUMP, OR ANY EVIDENCE OF DEVICE MIGRATION. SINCE THE PUMP IS ALLEGED TO HAVE CAUSED AN ULCER AND ARTERY PERFORATION REQUIRING SURGICAL INTERVENTION WHICH LEAD TO HIS EVENTUAL DEATH, THE EVENT MEETS MDR REPORTING CRITERIA. THERE IS VERY LIMITED INFORMATION AVAILABLE RELATED TO THE SEQUENCE OF EVENTS THAT LED UP TO THE ULCER, THE VESSEL PERFORATION AND THE EVENTUAL PATIENT DEATH. NO INFORMATION WAS REPORTED RELATED THE PATIENT MEDICAL HISTORY, OR ANY DIFFICULTY ENCOUNTERED DURING THE PUMP IMPLANTATION PROCEDURE ON (B)(6) 2018, AND THERE IS NO INFORMATION ON THE MEDICATION THAT THE PATIENT WAS RECEIVING VIA THE CODMAN PUMP. THERE WAS NO REPORT OF ANY PUMP MALFUNCTION. BASED ON THE DEVICE HISTORY RECORD REVIEW, THERE WAS NO ANOMALY DURING THE DEVICE MANUFACTURING PROCESS. AS PART OF THE POST MARKET SURVEILLANCE PROGRAM, INFORMATION FROM THIS COMPLAINT IS TRENDED FOR STATISTICAL SIGNALS AND CORRECTIVE/PREVENTIVE ACTION MAY BE TRIGGERED AT A LATER TIME. 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. THE MANUFACTURER WILL SUBMIT A SUPPLEMENTAL REPORT IF NEW FACTS ARISE WHICH MATERIALLY ALTER INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Additional Manufacturer Narrative · 1

    (B)(4). THE PURPOSE OF THIS MDR IS TO INCLUDE THE ADDITIONAL EVENT INFORMATION RECEIVED ON 7/12/2019. [CONCLUSION]: THE EVENT WAS REPORTED AS A WRITTEN NOTE ON A PATIENT FOLLOW-UP LETTER BY THE PATIENT¿S SPOUSE. IT WAS REPORTED THAT THE 30 ML HIG MODEL 3000 CODMAN CONSTANT FLOW IMPLANTABLE PUMP (AP03000H / LOT#: 15705) IMPLANTED IN THE PATIENT ON (B)(6) 2018 CAUSED AN ULCER IN THE PATIENT THAT RESULTED IN A MAJOR ARTERY PERFORATION. ON 12 JULY 2019, ADDITIONAL INFORMATION WAS PROVIDED BY THE PATIENT¿S WIFE. THE PATIENT HAD BEEN RECEIVING CHEMOTHERAPY VIA THE CODMAN 3000 CONSTANT FLOW IMPLANTABLE PUMP FOR TREATMENT OF ADVANCE COLON CANCER. THE PUMP WAS REFILLED IN (B)(6) AND (B)(6) 2018 WITHOUT INCIDENT. THE PATIENT¿S WIFE REPORTED THAT AT THIS POINT, SHE FELT THINGS WERE GOING WELL. IN (B)(6) 2018, THE PATIENT WENT IN TO GET THE PUMP REFILLED AND A SCAN WHICH REVEALED AN ULCER. ACCORDING TO THE PATIENT¿S WIFE, THE ULCER WAS LOCATED ON THE LIVER AT THE LOCATION WHERE THE CATHETER WAS PLACED TO DELIVER THE CHEMOTHERAPY MEDICATION. THE PHYSICIAN TOLD THE PATIENT¿S WIFE THAT THE ULCER LIKELY DEVELOPED BECAUSE OF A LEAK OF THE CHEMO MEDICATION AT THE SITE. THE CODMAN 3000 PUMP WAS WORKING PROPERLY AT THIS TIME BUT THERE WAS A LEAK REPORTED AT THE CATHETER CONNECTION SITE. THE PATIENT¿S WIFE REPORTED THAT SHE BELIEVES THAT THE DOCTORS WAITED TOO LONG TO CONDUCT THE SURGERY TO ADDRESS THE ULCER, AND BY THE TIME THEY PERFORMED THE SURGERY, THE ULCER HAD GROWN AND CAUSED A LEAK OF STOMACH ACID ONTO THE HEPATIC ARTERY RESULTING IN THE BLEEDING OF THE HEPATIC ARTERY. THE PATIENT UNDERWENT A TOTAL OF FOUR SURGERIES TO ADDRESS HIS CONDITION, ONE OF WHICH INCLUDED THE PUMP EXPLANTATION ON (B)(6) 2018. THE PATIENT NEVER RECOVERED AND SUBSEQUENTLY EXPIRED. THE PATIENT¿S WIFE STATED THAT THE DOCTORS DID NOT INDICATE THAT THE PUMP HAD MALFUNCTION, BUT THE LEAK AT THE CATHETER INSERTION SITE CAUSED THE PROBLEM. THE CODMAN PUMP WAS NOT RETURNED FOR INVESTIGATION. A REVIEW OF MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT (15705) PRESENTED NO ISSUES DURING THE MANUFACTURING OR INSPECTION PROCESSES RELATED TO THE REPORTED COMPLAINT. THERE WERE NO NON-CONFORMANCES RELATED TO DEVICE MANUFACTURE OR INSPECTION. ALL PRODUCT REJECTED DURING MANUFACTURING WAS IDENTIFIED AS SCRAP AND PROPERLY ACCOUNTED FOR. PRODUCT ANALYSIS CANNOT BE CONDUCTED AS THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. NO DETERMINATION OF CAUSES AND POSSIBLE CONTRIBUTING FACTORS COULD BE MADE. AS SUCH, THE INVESTIGATION WILL BE CLOSED. PRODUCT INVESTIGATION WILL BE REOPENED IF THE PUMP IS RETURNED. CATHETER LEAKAGE, EXTRAVASATION, ADVERSE TISSUE REACTION, AND DEATH ARE KNOWN POTENTIAL COMPLICATIONS ASSOCIATED WITH THE CODMAN 3000 CONSTANT FLOW IMPLANTABLE PUMP. THE INSTRUCTIONS FOR USE (IFU) OUTLINES INITIAL PUMP PREPARATION, IMPLANTATION, INITIAL FILLING, REFILLING AND INJECTING INTO THE BOLUS PORT OF THE PUMP. DURING PUMP IMPLANTATION, THE IFU INSTRUCTS THE USER TO PASS THE CATHETER THROUGH THE ANTERIOR ABDOMINAL WALL IN A WAY THAT ALLOWS FOR GENTLE CURVATURE OF THE CATHETER WITHOUT KINKING, AND TO ISOLATE A SUFFICIENT PORTION OF THE GASTRODUODENAL ARTERY BETWEEN 3-0 SILK SURGICAL TIES. THE CATHETER SHOULD BE INTRODUCED INTO THE GASTRODUODENAL ARTERY USING A HEIFITZ OCCLUSION CLAMP AND ITS TIP ADVANCED TO THE JUNCTION OF THE GASTRODUODENAL ARTERY AND THE HEPATIC ARTERY. NO PORTION OF THE CATHETER SHOULD BE INSERTED INTO THE HEPATIC ARTERY. THE CATHETER SHOULD BE TIED IN PLACE WITH AT LEAST THREE 3-0 SILK SUTURES TO PREVENT KINKING. THE PUMP CATHETER SHOULD BE SUTURED TO PREVENT CATHETER DISLODGEMENT. WHEN SUTURING AROUND THE SOFT CATHETER, EXCESSIVE SUTURE TIGHTNESS AND PINCHING OF THE CATHETER SHOULD BE AVOIDED AS THIS CAN OBSTRUCT FLOW. AN OBSTRUCTED CATHETER CAN REQUIRE FUTURE SURGICAL CORRECTION. SUFFICIENT SLACK BETWEEN THE CATHETER ATTACHMENT AND PUMP SHOULD BE ALLOWED TO AVOID STRAIN AT THE CANNULATED SITE. THE ROOT CAUSE OF THE EVENT CANNOT BE CONCLUSIVELY DETERMINED BASED ON THE LIMITED INFORMATION AVAILABLE FOR REVIEW; HOWEVER, IT IS POSSIBLE THAT PROCEDURAL (IMPLANT) AND/OR PATIENT FACTORS MAY HAVE CONTRIBUTED WITH NO INDICATION OF A PUMP MALFUNCTION. SINCE THE ALLEGED CATHETER LEAKAGE AND DRUG EXTRAVASATION CAUSED AN ULCER AND BLEEDING NECESSITATING SURGICAL INTERVENTION, AND THIS EVENTUALLY LED TO THE DEATH OF THE PATIENT, THE EVENT MEETS MDR REPORTING CRITERIA WITH CLASSIFICATION OF ¿DEATH.¿ THERE WAS NO REPORT OF ANY PUMP MALFUNCTION. THE SILICONE RUBBER CATHETER IS A PRE-ATTACHED COMPONENT TO THE DELIVERY PUMP; THE LEAK OCCURRED AT THE CATHETER INSERTION SITE. INFORMATION RELATED TO THE PUMP IMPLANTATION, CATHETER INSERTION / CATHETER CONNECTION IS LIMITED. THE ROOT CAUSE OF THE EVENT CANNOT BE CONCLUSIVELY DETERMINED. BASED ON THE DEVICE HISTORY RECORD REVIEW, THERE WAS NO ANOMALY DURING THE DEVICE MANUFACTURING PROCESS. AS PART OF THE POST MARKET SURVEILLANCE PROGRAM, INFORMATION FROM THIS COMPLAINT IS TRENDED FOR STATISTICAL SIGNALS AND CORRECTIVE/PREVENTIVE ACTION MAY BE TRIGGERED AT A LATER TIME. 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. THE MANUFACTURER WILL SUBMIT A SUPPLEMENTAL REPORT IF NEW FACTS ARISE WHICH MATERIALLY ALTER INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Description of Event or Problem · 1

    THE EVENT WAS REPORTED AS A WRITTEN NOTE ON A PATIENT FOLLOW-UP LETTER BY THE PATIENT¿S SPOUSE. IT WAS REPORTED THAT THE 30ML HIG MODEL 3000 CODMAN CONSTANT FLOW IMPLANTABLE PUMP (AP03000H / LOT#: 15705) IMPLANTED IN THE PATIENT ON (B)(6) 2018 CAUSED AN ULCER IN THE PATIENT THAT RESULTED IN A MAJOR ARTERY PERFORATION. THE PUMP WAS EXPLANTED ON (B)(6) 2018. THE PATIENT UNDERWENT MAJOR SURGERY TO REPAIR THE DAMAGE FROM THE PUMP WHICH ULTIMATELY RESULTED IN THE DEATH OF THE PATIENT. NO OTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    530551 MODEL 3000 - 30ML VOLUME, HIG PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK CODMAN AND SHURTLEFF, INC 15705 10886704043591

    Patients

    Seq Age Sex Outcome Treatment
    1 Death