INTERA 3000
Report
- Report Number
- 3015537318-2024-00059
- Event Type
- Malfunction
- Date Received
- July 1, 2024
- Date of Event
- June 10, 2024
- Report Date
- August 23, 2024
- Manufacturer
- INTERA ONCOLOGY, INC
- Product Code
- LKK
- UDI-DI
- 00850014110147
- PMA / PMN Number
- P890055
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
THE DEVICE HISTORY RECORD FOR THIS DEVICE WAS REVIEWED. THERE WERE NO NONCONFORMANCES RELATED TO THE MANUFACTURE OF THIS LOT OF PRODUCT. THERE WAS 1 DEVIATION RELATED TO THIS LOT OF PRODUCT. THE SILICONE ADHESIVE USED IN THE MANUFACTURE OF THIS DEVICE WAS RECEIVED IN A 2OZ. CONTAINER, INSTEAD OF A 6OZ. CONTAINER. AS THE SILICONE ADHESIVE IS THE SAME MATERIAL BUT ONLY IN A SMALLER CONTAINER, THERE WAS NO IMPACT ON THE MANUFACTURE OF THE DEVICE. THE DEVICE PASSED ALL FUNCTIONAL AND PERFORMANCE TESTS PRIOR TO RELEASE FROM MANUFACTURING. THE DEVICE REMAINS IMPLANTED AT THE TIME OF THIS REPORT. IF ADDITIONAL INFORMATION IS RECEIVED AT A LATER DATE, A SUPPLEMENTAL REPORT WILL BE FILED.
THE DEVICE HISTORY RECORD FOR THIS DEVICE WAS REVIEWED. THERE WERE NO NONCONFORMANCES RELATED TO THE MANUFACTURE OF THIS LOT OF PRODUCT. THERE WAS 1 DEVIATION RELATED TO THIS LOT OF PRODUCT. THE SILICONE ADHESIVE USED IN THE MANUFACTURE OF THIS DEVICE WAS RECEIVED IN A 2OZ. CONTAINER, INSTEAD OF A 6OZ. CONTAINER. AS THE SILICONE ADHESIVE IS THE SAME MATERIAL BUT ONLY IN A SMALLER CONTAINER, THERE WAS NO IMPACT ON THE MANUFACTURE OF THE DEVICE. THE DEVICE PASSED ALL FUNCTIONAL AND PERFORMANCE TESTS PRIOR TO RELEASE FROM MANUFACTURING. THE DEVICE REMAINS IMPLANTED AT THE TIME OF THIS REPORT. SUPPLEMENT IS TO ADD ADDITIONAL INFORMATION PROVIDED BY THE PHYSICIAN. THE PRODUCT WAS NOT RETURNED FOR EVALUATION AS IT REMAINS IMPLANTED AT THE TIME OF THIS REPORT. IF ADDITIONAL INFORMATION IS RECEIVED AT A LATER DATE, A SUPPLEMENTAL REPORT WILL BE FILED.
HEALTHCARE PROVIDER REPORTED THAT AN INTERA 3000 HEPATIC ARTERY INFUSION PUMP THAT HAD BEEN IMPLANTED 9 MONTHS PRIOR WAS NOW FLOWING FASTER. THE REPORTED FLOW RATE OF THE PUMP AS CALCULATED BY THE HEALTHCARE PROVIDER IS ABOUT 1.9ML/DAY. THE HEALTHCARE PROVIDER IS NOW PERFORMING 1 WEEK REFILLS, AS OPPOSED TO 2 WEEK REFILLS. THERE ARE NO PATIENT FACTORS, HEAT, OR ELEVATION TO EXPLAIN THE INCREASE IN FLOW RATE. THE HEALTHCARE PROVIDER IS CONTINUING TO MONITOR THE SITUATION BUT HAS NOT YET EXPLANTED THE DEVICE. REPORTED FLOW RATES ARE 1.36ML/DAY ON 5/6, 1.5 ML/DAY ON 5/20, 1.68ML/DAY ON 6/3, AND 1.86ML/DAY ON 6/10.
HEALTHCARE PROVIDER REPORTED THAT AN INTERA 3000 HEPATIC ARTERY INFUSION PUMP THAT HAD BEEN IMPLANTED 9 MONTHS PRIOR WAS NOW FLOWING FASTER. THE REPORTED FLOW RATE OF THE PUMP AS CALCULATED BY THE HEALTHCARE PROVIDER IS ABOUT 1.9ML/DAY. THE HEALTHCARE PROVIDER IS NOW PERFORMING 1 WEEK REFILLS, AS OPPOSED TO 2 WEEK REFILLS. THERE ARE NO PATIENT FACTORS, HEAT, OR ELEVATION TO EXPLAIN THE INCREASE IN FLOW RATE. THE HEALTHCARE PROVIDER IS CONTINUING TO MONITOR THE SITUATION BUT HAS NOT YET EXPLANTED THE DEVICE. REPORTED FLOW RATES ARE 1.36ML/DAY ON 5/6, 1.5 ML/DAY ON 5/20, 1.68ML/DAY ON 6/3, AND 1.86ML/DAY ON 6/10. AS OF (B)(6) 2024, THE PUMP REMAINS IMPLANTED IN THE PATIENT. THE PHYSICIAN REPORTED TO INTERA THAT THEY BELIEVE THE ELEVATED FLOW RATE IS DUE TO A HEAT-RELATEED ISSUE AS THE PATIENT WORKS IN A GARDEN. THEY REPORTED THAT THE PUMP IS FLOWING SLOWER THAT INITIALLY REPORTED AND WILL CONTINUE TO MONITOR.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1270934 | INTERA 3000 | HEPATIC ARTERY INFUSION PUMP | LKK | INTERA ONCOLOGY, INC | AP03000H | 29084 | 00850014110147 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Male | Required Intervention |