BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MODEL 3000 30ML HIGH FLOW PUMP

    MDR report key: 5474322 · Received March 2, 2016

    Report

    Report Number
    1226348-2016-10162
    Event Type
    Injury
    Date Received
    March 2, 2016
    Date of Event
    February 10, 2016
    Manufacturer
    CODMAN & SHURTLEFF, INC.
    Product Code
    LKK
    PMA / PMN Number
    PP890055
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP REMAINS IMPLANTED, THUS WAS NOT RETURNED FOR EVALUATION. AS SUCH IT IS NOT POSSIBLE TO EVALUATE THE PUMP AND DETERMINE THE ROOT CAUSE OF THIS COMPLAINT. FURTHERMORE, THE S/N WAS NOT PROVIDED; THEREFORE, A REVIEW OF THE DEVICE HISTORY COULD NOT BE PERFORMED. AT THIS TIME THIS COMPLAINT IS CONSIDERED TO BE CLOSED. SHOULD THE PUMP BE RETURNED AT A LATER DATE, THIS COMPLAINT WILL BE RE-OPENED AND AN EVALUATION WILL BE PERFORMED. AND ONCE THE S/N IS VERIFIED THE DHR RECORDS WILL BE REVIEWED.

    Additional Manufacturer Narrative · 1

    (B)(4). UPON COMPLETION OF THE INVESTIGATION, A FOLLOW UP REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 1

    (B)(4). UPON COMPLETION OF THE INVESTIGATION IT WAS NOTED THAT THE VISUAL EXAMINATION OF THE EXTERIOR SURFACES OF THIS PUMP DID NOT REVEAL ANY ANOMALIES INCLUDING METALLURGIC DEFECTS ON THE METAL SURFACES. THE CENTER SEPTUM REVEALED SEVERAL PENETRATION MARKS THROUGHOUT. THERE IS NO EVIDENCE OF CUTS OR DAMAGE ON THE SILICONE SURFACE. THE CATHETER HAD BEEN CUT APPROXIMATELY 1 INCH FROM THE STRAIN RELIEF. THE CATHETER WAS NOT TIED OR CLAMPED AT THE DISTAL END WHEN RECEIVED. VISUAL EVALUATION OF THE DISTAL END OF THE CATHETER REVEALED A CLEAN AND OPEN FLOW PATH. THE RESERVOIR WAS ACCESSED WITH A SPECIAL BOLUS NEEDLE WITH NOT RESISTANCE. THE BOLUS PATHWAY COULD BE FLUSHED ON THE FIRST ATTEMPT WITH NO RESISTANCE INDICATING THAT THE FLOW PATH IS PATENT AND ANOMALY FREE. THE "ACCESSING" DIFFICULTIES EXPERIENCED IN THE CLINICAL SETTING COULD NOT BE VERIFIED IN THE LABORATORY. THE PUMP WAS EMPTIED; APPROXIMATELY 22MLS OF CLEAR PARTICLE FREE FLUID WAS COLLECTED FROM THE RESERVOIR. THE BOLUS PATHWAY, AND ATTACHED CATHETER COULD BE FLUSHED WITH NO RESISTANCE. CLEAR, PARTICLE FREE FLUID WAS COLLECTED. THERE WAS NO EVIDENCE OF LEAKAGE WHEN FLUSHING AND PRESSURIZING THE BOLUS PATHWAY AND CATHETER, LEAKS WERE NOT FOUND. LEAKAGE WAS ALSO NOT FOUND WHEN FILLING THE PUMP WITH FLUID, THIS PUMP APPEARS TO BE LEAK TIGHT. THE PUMP WAS FILLED WITH 30MLS OF BACTERIOSTATIC WATER AND PLACED IN A 37 CELSIUS WATER BATH FOR FLOW TESTING. THIS PUMP FLOWED 1.39MLS/DAY, 77% OF THE MANUFACTURED FOLLOW RATE OF 1.8MLS/DAY. THIS FLOW RATE IS SLIGHTLY SLOWER THAT THE SPECIFICATION (85% TO 115%) OF THE MANUFACTURED FLOW RATE. THE SLOW FLOW CONDITION ENCOUNTERED IN THE LABORATORY MAY BE ASSOCIATED WITH AIR BEING INTRODUCED INTO THE PUMP FLOW PATH DURING SHIPPING. THE CATHETER FLOW PATH WAS NOT CLAMPED PRIOR TO SHIPPING. OR DUE TO PARTIAL FLOW OBSTRUCTION OF THE CAPILLARY FLOW PATH AND/OR FILTER MATERIAL WITH DRUG PRECIPITATE, HOWEVER; THIS WAS NOT CONFIRMED. A REVIEW OF THE DEVICE HISTORY RECORDS INDICATED THAT THIS PUMP MET ALL TESTING REQUIREMENTS DURING MANUFACTURING PROCESSES. WE WILL CONTINUE TO MONITOR FOR THIS OR SIMILAR COMPLAINTS FOR THIS PRODUCT CODE. THE REPORTED DIFFICULTIES ACCESSING THE PUMP IN THE CLINICAL SETTING COULD NOT BE DUPLICATED IN THE LABORATORY. FURTHERMORE, THE REPORTED "SMALL AMOUNTS OF FLUID LEAKING OUT OF ONE OF THE NEEDLE PUNCTURE SITES ON HER SKIN" COULD NOT BE VERIFIED, THIS PUMP IS LEAK TIGHT. IT IS LIKELY THAT THE "FLUID" WAS LEAKING FROM THE PUMP POCKET; HOWEVER, THIS COULD NOT BE CONFIRMED. BASED ON THE RESULTS OF THIS INVESTIGATION NO FURTHER ACTION IS REQUIRED. TRENDS WILL BE MONITORED FOR THIS AND SIMILAR COMPLAINTS. AT THE PRESENT TIME THIS COMPLAINT IS CLOSED.

    Description of Event or Problem · 1

    UPDATE 3/24/16 PLEASE ADD THIS TO THE COMPLAINT INFORMATION. BEFORE THE SURGERY TO REPLACE THIS PUMP THE SURGEON TOLD ME THE MEDICAL ONCOLOGY INFUSION CLINIC WAS USING THE PUMP OFF LABEL BY REGULARLY ACCESSING THE PUMP WITH THE SPECIAL BOLUS NEEDLE AND INFUSING OXALIPLATIN (I BELIEVE THAT WAS THE DRUG HE MENTIONED).

    Description of Event or Problem · 1

    USED SPECIAL BOLUS NEEDLE AND FLUID CAME OUT OF SEPTUM AND PATIENT'S SKIN. EVENT DID NOT OCCUR INTRA OPERATIVELY AND CAUSED NO DELAYS OVER 30 MINUTES. "HERE IS THE EMAIL I RECEIVED FROM (B)(6): WE HAVE A PATIENT WHO'S HAD THE PUMP FOR A WHILE NOW. IT QUITE OFTEN TAKES A NUMBER OF ATTEMPTS TO GET HER PUMP ACCESSED. YESTERDAY IT TOOK 4 NURSES 5 ATTEMPTS TO ACCESS HER PUMP. AFTER ACCESS, AS THEY PUSHED IN A BOLUS OF FLUID TO TEST NEEDLE PLACEMENT, THEY NOTICED SMALL AMOUNTS OF FLUID LEAKING OUT OF ONE OF THE NEEDLE PUNCTURE SITES ON HER SKIN, LEADING US TO QUESTION THE INTEGRITY OF THE SEPTUM. OUR QUESTION FOR YOU IS: WHAT IS THE BEST METHOD OF VERIFYING THIS? IS IT THE TECHNETIUM LIVER PUMP STUDY? OR IS THERE SOME OTHER STUDY? (B)(4) 2016 PER REP: DID THE REPORTED INCIDENT CAUSE A DELAY IN THE PROCEDURE OVER 30 MINUTES? I DON'T KNOW THE ANSWER TO THIS QUESTION BUT THE "PROCEDURE" WAS NOT SURGERY. THEY WERE USING THE SBN TO INFUSE AN OFF LABEL DRUG THROUGH THE CATHETER. WHAT ACTIONS WERE TAKEN AS A RESULT OF THIS INCIDENT? I STRONGLY ADVISED THEM TO REPORT THIS TO THE SURGICAL ONCOLOGIST. IS THE DEVICE BEING RETURNED FOR EVALUATION? IF THE PUMP IS EXPLANTED, I WILL MAKE ARRANGEMENTS TO HAVE IT SENT BACK TO CODMAN FOR EVALUATION. IS THERE A SERIAL OR LOT NUMBER YOU CAN PROVIDE? NOT AT THIS TIME. PLEASE VERIFY THE DATE YOU WERE FIRST NOTIFIED OF THIS INCIDENT. (B)(6) CALLED ME (B)(6). SHE AND I HAD DISCUSSED THE SEPTUM AND AMOUNT OF STICKS IT IS FDA APPROVED FOR ON (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    130537 MODEL 3000 30ML HIGH FLOW PUMP PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK CODMAN & SHURTLEFF, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention