INTERA 3000
Report
- Report Number
- 3015537318-2023-00048
- Event Type
- Malfunction
- Date Received
- December 6, 2023
- Date of Event
- October 5, 2023
- Report Date
- September 17, 2024
- Manufacturer
- INTERA ONCOLOGY
- Product Code
- LKK
- UDI-DI
- 00850014110147
- PMA / PMN Number
- P890055
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- PHARMACIST
- Health Professional
- Yes
Narratives
THE DEVICE HISTORY RECORD WAS REVIEWED. THIS SERIAL NUMBER WAS PULLED AND SAMPLED FOR BIOBURDEN TESTING AND THEN RETURNED TO THE LOT DURING PROCESSING, WHICH IS A STANDARD PART OF THE MANUFACTURING PROCEDURE. AT OPERATION 0110 IN THE PROCEDURE, 4 HOUR FLOW TEST INITIATION, THIS SERIAL NUMBER REQUIRED SETUP IN THE 60 DEG C WATER BATH TO INITIATE FLOW. THIS IS AN ALLOWABLE STEP IN MANUFACTURING. THERE WERE NONCONFORMANCES OR DEVIATIONS PERTAINING TO THIS SERIAL NUMBER. THE DEVICE MET ALL SPECIFICATIONS PRIOR TO RELEASE FROM MANUFACTURING. THE DEVICE REMAINS IMPLANTED AT THIS TIME. BLANK FIELDS IN THE MDR FORM REPRESENT UNKNOWN INFORMATION. IF FURTHER INFORMATION IS RECEIVED AT A LATER DATE, A SUPPLEMENTAL REPORT WILL BE FILED.
AN EVALUATION OF THE DEVICE POST EXPLANT IS PLANNED. WHEN THE EVALUATION IS COMPLETED, A SUPPLEMENT WILL BE FILED. IF FURTHER INFORMATION IS RECEIVED AT A LATER DATE, A SUPPLEMENTAL REPORT WILL BE FILED.
.ADD PATIENT INFORMATION. THE DEVICE WAS EVALUATED AND DETERMINED TO HAVE AN OCCLUDED FILTER. IF ADDITIONAL INFORMATION IS RECEIVED AT A LATER DATE, A SUPPLEMENTAL REPORT WILL BE FILED.
INTERA ONCOLOGY RECEIVED A REPORT FROM A HEALTHCARE PROVIDER REGARDING AN INTERA 3000 HEPATIC ARTERY INFUSION PUMP, IMPLANTED ON (B)(6) 2023. ON 10/05/2023, 24 ML OF INFUSATE WAS RETURNED DURING THE REFILL PROCEDURE, MEANING THE CALCULATED FLOW RATE WAS 0.42 ML/DAY. ON (B)(6) 2023, ALL 30 ML OF INFUSATE WAS RETURNED DURING THE REFILL. IT WAS REPORTED THAT THE THE SURGEON/MEDICAL ONCOLOGIST WAS MADE AWARE AND USED A SPECIAL BOLUS NEEDLE TO SEE IF CATHETER WAS STILL PATENT, IT WAS REPORTED THE HEALTHCARE PROVIDED THE PATIENT TO NUCLEAR MEDICINE TO PERFORM A SCAN, WHERE HE REPORTED "HE WAS HAPPY WITH THE HEPATIC PERFUSION." ON 10/26/2023, IT WAS REPORTED THAT 25 ML CAME BACK DURING THE REFILL, MEANING A CALCULATED FLOW RATE OF 0.5 ML/DAY.
INTERA ONCOLOGY RECEIVED A REPORT FROM A HEALTHCARE PROVIDER REGARDING AN INTERA 3000 HEPATIC ARTERY INFUSION PUMP, IMPLANTED ON (B)(6), 2023. ON (B)(6) 2023, 24 ML OF INFUSATE WAS RETURNED DURING THE REFILL PROCEDURE, MEANING THE CALCULATED FLOW RATE WAS 0.42 ML/DAY. ON (B)(6)2023, ALL 30 ML OF INFUSATE WAS RETURNED DURING THE REFILL. IT WAS REPORTED THAT THE THE SURGEON/MEDICAL ONCOLOGIST WAS MADE AWARE AND USED A SPECIAL BOLUS NEEDLE TO SEE IF CATHETER WAS STILL PATENT, IT WAS REPORTED THE THE HEALTHCARE PROVIDED THE PATIENT TO NUCLEAR MEDICINE TO PERFORM A SCAN, WHERE HE REPORTED "HE WAS HAPPY WITH THE HEPATIC PERFUSION." ON (B)(6) 2023, IT WAS REPORTED THAT 25 ML CAME BACK DURING THE REFILL, MEANING A CALCULATED FLOW RATE OF 0.5 ML/DAY. ADDITIONAL INFORMATION RECEIVED: PUMP WAS FILLED (B)(6) 2023 WITH 30 ML REMOVED (FLOW RATE 0.0). IT WITH SPECIAL BOLUS NEEDLE 10/18/23 AND FILLED WITH HEPARIN. PUMP FILL (B)(6) 2023 HE HAD 25 ML REMOVED (FLOW RATE 0.5). PUMP FILL (B)(6) 2023 WITH 29 ML OUT (0.07 FLOW RATE). EXPERIENCING ELEVATED LFTS [LIVER FUNCTION TESTS] SIMULTANEOUSLY SO THE HEATHCARE PROVIDER CONTACT INTERA [PER THE INITIAL REPORT]. IT WAS REPORTED THAT THE THE CATHETER FLUSHED WITHOUT RESISTANCE USING THE SPECIAL BOLUS NEEDLE, AND NUCLEAR MEDICINE STUDIES HAVE SHOWN APPROPRIATE UPTAKE IN THE LIVER. IT WAS DESCRIBED THAT A KINK OR OBSTRUCTION IN THE PUMP POCKET IS A THEORETICAL CONCERN, BUT WOULD REQUIRE SURGICAL EXPLORATION AT A TIME WHEN THE PATIENT AND MEDICAL ONCOLOGIST WERE 'KEEN TO RESUME SYSTEMIC THERAPY.' THE HEALTHCARE PROVIDER DECIDED TO KEEP THE PUMP FILLED WITH HEPARIN AND MONITOR THE LFTS AND BEGIN SYSTEMIC THERAPY. IT WAS REPORTED THAT "IF [LFTS] BEGIN TO DECLINE TO LEVELS THAT WOULD ALLOW FUDR [FLOXURIDINE] INFUSION, THEN [THE HEALTHCARE PROVIDER WOULD] TAKE A MORE AGGRESSIVE APPROACH TO EXPLORING THE PUMP POCKET OR TROUBLESHOOTING THE PUMP ITSELF. IN THE MEANTIME, THE PATIENT IS AWARE THAT PERMANENT PUMP FAILURE IS A POSSIBILITY DUE TO PERSISTENT LOW FLOW RATE." IT WAS REPORTED THAT THE PUMP REFILL ON (B)(6) 2023 HAD A CALCULATED FLOW RATE OF 0 ML/DAY. THE PATIENT HAD PERI-HEPATIC FLUID COLLECTION OF 140 ML REMOVED ON (B)(6) 2023. IT WAS INSTILLED WITH GLYCERIN AND CHECKED (B)(6) 2024 WITH A FLOW RATE OF 0 ML/DAY. THE PATIENT WAS DUE FOR PUMP REFILL (B)(6) 2024 BUT THE HEALTHCARE PROVIDER USED SPECIAL BOLUS NEEDLE TO FLUSH. THE DECISION MADE TO REMOVE PUMP INSTEAD. THE EXPLANT DATE WAS CURRENTLY PLANNED FOR (B)(6)2024. IT WAS LATER DISCUSSED WITH INTERA THAT THE SURGEON'S OPINION WAS THAT THE ISSUE WAS POSSIBLY RELATED TO THE PATIENT'S ABERRANT ATRIAL ANATOMY. HOWEVER, THE DEVICE IS SUBJECT TO RETURN TO INTERA FOR EVALUATION.
INTERA ONCOLOGY RECEIVED A REPORT FROM A HEALTHCARE PROVIDER REGARDING AN INTERA 3000 HEPATIC ARTERY INFUSION PUMP, IMPLANTED ON (B)(6) 2023. ON (B)(6) 2023, 24 ML OF INFUSATE WAS RETURNED DURING THE REFILL PROCEDURE, MEANING THE CALCULATED FLOW RATE WAS 0.42 ML/DAY. ON (B)(6) 2023, ALL 30 ML OF INFUSATE WAS RETURNED DURING THE REFILL. IT WAS REPORTED THAT THE SURGEON/MEDICAL ONCOLOGIST WAS MADE AWARE AND USED A SPECIAL BOLUS NEEDLE TO SEE IF CATHETER WAS STILL PATENT, IT WAS REPORTED THE HEALTHCARE PROVIDED THE PATIENT TO NUCLEAR MEDICINE TO PERFORM A SCAN, WHERE HE REPORTED "HE WAS HAPPY WITH THE HEPATIC PERFUSION." ON (B)(6) 2023, IT WAS REPORTED THAT 25 ML CAME BACK DURING THE REFILL, MEANING A CALCULATED FLOW RATE OF 0.5 ML/DAY. ADDITIONAL INFORMATION RECEIVED: PUMP WAS FILLED 10/16/23 WITH 30 ML REMOVED (FLOW RATE 0.0). IT WITH SPECIAL BOLUS NEEDLE ON (B)(6) 23 AND FILLED WITH HEPARIN. PUMP FILL (B)(6) 2023 HE HAD 25 ML REMOVED (FLOW RATE 0.5). PUMP FILL (B)(6) 2023 WITH 29 ML OUT (0.07 FLOW RATE). EXPERIENCING ELEVATED LFTS [LIVER FUNCTION TESTS] SIMULATENOUSLY SO THE HEATHCARE PROVIDER CONTACT INTERA [PER THE INITIAL REPORT]. IT WAS REPORTED THAT THE CATHETER FLUSHED WITHOUT RESISTANCE USING THE SPECIAL BOLUS NEEDLE, AND NUCLEAR MEDICINE STUDIES HAVE SHOWN APPROPRIATE UPTAKE IN THE LIVER. IT WAS DESCRIBED THAT A KINK OR OBSTRUCTION IN THE PUMP POCKET IS A THEORETICAL CONCERN BUT WOULD REQUIRE SURGICAL EXPLORATION AT A TIME WHEN THE PATIENT AND MEDICAL ONCOLOGIST WERE 'KEEN TO RESUME SYSTEMIC THERAPY.' THE HEALTHCARE PROVIDER DECIDED TO KEEP THE PUMP FILLED WITH HEPARIN AND MONITOR THE LFTS AND BEGIN SYSTEMIC THERAPY. IT WAS REPORTED THAT "IF [LFTS] BEGIN TO DECLINE TO LEVELS THAT WOULD ALLOW FUDR [FLOXURIDINE] INFUSION, THEN [THE HEALTHCARE PROVIDER WOULD] TAKE A MORE AGGRESSIVE APPROACH TO EXPLORING THE PUMP POCKET OR TROUBLESHOOTING THE PUMP ITSELF. IN THE MEANTIME, THE PATIENT IS AWARE THAT PERMANENT PUMP FAILURE IS A POSSIBILITY DUE TO PERSISTENT LOW FLOW RATE." IT WAS REPORTED THAT THE PUMP REFILL ON (B)(6) 2023 HAD A CALCULATED FLOW RATE OF 0 ML/DAY. THE PATIENT HAD PERI-HEPATIC FLUID COLLECTION OF 140 ML REMOVED ON (B)(6) 2023. IT WAS INSTILLED WITH GLYCERIN AND CHECKED ON (B)(6) 2024 WITH A FLOW RATE OF 0 ML/DAY. THE PATIENT WAS DUE FOR PUMP REFILL (B)(6) 2024 BUT THE HEALTHCARE PROVIDER USED SPECIAL BOLUS NEEDLE TO FLUSH. THE DECISION MADE TO REMOVE PUMP INSTEAD. THE EXPLANT DATE WAS CURRENTLY PLANNED FOR (B)(6) 2024. IT WAS LATER DISCUSSED WITH INTERA THAT THE SURGEON'S OPINION WAS THAT THE ISSUE WAS POSSIBLY RELATED TO THE PATIENT'S ABERRANT ATERIAL ANATOMY. HOWEVER, THE DEVICE IS SUBJECT TO RETURN TO INTERA FOR EVALUATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 877377 | INTERA 3000 | HEPATIC ARTERY INFUSION PUMP | LKK | INTERA ONCOLOGY | AP03000H | 27663661 | 00850014110147 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 56 YR | Male | Hospitalization| R |