INTERA 3000
Report
- Report Number
- 3015537318-2024-00072
- Event Type
- Malfunction
- Date Received
- August 28, 2024
- Date of Event
- August 2, 2024
- Report Date
- January 27, 2025
- Manufacturer
- INTERA ONCOLOGY, INC
- Product Code
- LKK
- UDI-DI
- 00850014110147
- PMA / PMN Number
- P890055
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
ADDITIONAL FOLLOW UP INVESTIGATION DETERMINED THAT THE ROOT CAUSE WAS LIKELY RELATED TO ALIGNMENT OF THE CATHETER CONNECTION. UPDATED DEVICE COMPONENT CODE.
THE DEVICE HAS BEEN REQUESTED BUT HAS NOT YET BEEN RETURNED TO INTERA FOR EVALUATION. WHEN THE DEVICE IS RECEIVED, EVALUATED AND INVESTIGATION COMPLETED, A SUPPLEMENT REPORT WILL BE FILED. BLANK FIELDS IN THE MDR FORM REPRESENT UNKNOWN INFORMATION AT THE TIME OF THIS REPORT.
PATIENT INFORMATION ADDED. THE DEVICE WAS TESTED ON THE BENCH UNDER PROTOCOL AND DID NOT INITIALLY FLOW AS EXPECTED. AFTER MANIPULATION OF THE INTERNAL FLOW PATH, FLOW WAS OBSERVED AS EXPECTED. ITHE EXACT ROOT CAUSE IS UNDERTERMINED BUT LIKELY LINKED TO AN ISSUE WITH COMPONENT ALIGNMENT.
IT WAS REPORTED THAT AN INTERA 3000 HEPATIC ARTERY INFUSION PUMP WAS NOT FLOWING AFTER IMPLANT. THE DEVICE WAS IMPLANTED ON (B)(6) 2024. THE PATIENT PRESENTED TO INFUSION SUITE ON (B)(6) 2024 FOR THEIR INITIAL REFILL. THE SURGEON REPORTED THAT PUMP RETURNED 29 ML INTO COLLECTION SYRINGE. THE SURGEON WAS ABLE TO FLUSH THE CATHETER USING SPECIAL BOLUS NEEDLE AND REPORTED NO RESISTANCE TO FLOW. PATIENT SENT HOME AFTER FILLING PUMP WITH HIGH-DOSE HEPARINIZED SALINE, AS PER PROTOCOL AND REQUESTED THAT PATIENT APPLY HEAT OVER PUMP IMPLANTATION SITE AND RETURN ON (B)(6) 2024 TO RE-ATTEMPT REFILL. ON (B)(6) 2024, THE HEALTHCARE PROVIDER ATTEMPTED TO REFILL PUMP: 30 ML OF HIGH-DOSE HEPARIN RETURNED TO COLLECTING SYRINGE. THE SURGEON ORDERED CT SCAN AND INTRODUCED TPA INTO THE CATHETER ON (B)(6) 2024. THE PUMP WAS EXPLANTED AND REPLACED ON (B)(6) 2024. INTRAOPERATIVELY, THE SURGEON EMPTIED THE PUMP TO DETERMINE IF THE TPA INSTILLED INTO THE CATHETER HAD REINSTATED FLOW. THE PUMP EMPTIED 12 ML. THE SURGEON INDICATED THAT HE HAD IN "AROUND 18-20 ML" ON (B)(6) 2024, WHICH INDICATES THAT THE PUMP WAS FLOWING AND HAD FLOWED APPROXIMATELY 6-8 ML OVER THE 6 DAY PERIOD. NEXT REFILL IS PENDING AND THEREFORE THE DATA ARE NOT AVAILABLE AT THE TIME OF THIS REPORT. HAPS SCAN POST IMPLANT SHOWED NO EXTRAHEPATIC FLOW.
IT WAS REPORTED THAT AN INTERA 3000 HEPATIC ARTERY INFUSION PUMP WAS NOT FLOWING AFTER IMPLANT. THE DEVICE WAS IMPLANTED ON (B)(6) 2024. THE PATIENT PRESENTED TO INFUSION SUITE ON 02 AUGUST 2024 FOR THEIR INITIAL REFILL. THE SURGEON REPORTED THAT PUMP RETURNED 29 ML INTO COLLECTION SYRINGE. THE SURGEON WAS ABLE TO FLUSH THE CATHETER USING SPECIAL BOLUS NEEDLE AND REPORTED NO RESISTANCE TO FLOW. PATIENT SENT HOME AFTER FILLING PUMP WITH HIGH-DOSE HEPARINIZED SALINE, AS PER PROTOCOL AND REQUESTED THAT PATIENT APPLY HEAT OVER PUMP IMPLANTATION SITE AND RETURN ON 09 AUGUST 2024 TO RE-ATTEMPT REFILL. ON 09 AUGUST 2024, THE HEALTHCARE PROVIDER ATTEMPTED TO REFILL PUMP: 30 ML OF HIGH-DOSE HEPARIN RETURNED TO COLLECTING SYRINGE. THE SURGEON ORDERED CT SCAN AND INTRODUCED TPA INTO THE CATHETER ON 14 AUGUST 2024. THE PUMP WAS EXPLANTED AND REPLACED ON (B)(6) 2024. INTRAOPERATIVELY, THE SURGEON EMPTIED THE PUMP TO DETERMINE IF THE TPA INSTILLED INTO THE CATHETER HAD REINSTATED FLOW. THE PUMP EMPTIED 12 ML. THE SURGEON INDICATED THAT HE HAD IN "AROUND 18-20 ML" ON 14 AUGUST 2024, WHICH INDICATES THAT THE PUMP WAS FLOWING AND HAD FLOWED APPROXIMATELY 6-8 ML OVER THE 6 DAY PERIOD. NEXT REFILL IS PENDING AND THEREFORE THE DATA ARE NOT AVAILABLE AT THE TIME OF THIS REPORT. HAPS SCAN POST IMPLANT SHOWED NO EXTRAHEPATIC FLOW.
IT WAS REPORTED THAT AN INTERA 3000 HEPATIC ARTERY INFUSION PUMP WAS NOT FLOWING AFTER IMPLANT. THE DEVICE WAS IMPLANTED ON (B)(6) 2024. THE PATIENT PRESENTED TO INFUSION SUITE ON (B)(6) 2024 FOR THEIR INITIAL REFILL. THE SURGEON REPORTED THAT PUMP RETURNED 29 ML INTO COLLECTION SYRINGE. THE SURGEON WAS ABLE TO FLUSH THE CATHETER USING SPECIAL BOLUS NEEDLE AND REPORTED NO RESISTANCE TO FLOW. PATIENT SENT HOME AFTER FILLING PUMP WITH HIGH-DOSE HEPARINIZED SALINE, AS PER PROTOCOL AND REQUESTED THAT PATIENT APPLY HEAT OVER PUMP IMPLANTATION SITE AND RETURN ON (B)(6) 2024 TO RE-ATTEMPT REFILL. ON (B)(6) 2024, THE HEALTHCARE PROVIDER ATTEMPTED TO REFILL PUMP: 30 ML OF HIGH-DOSE HEPARIN RETURNED TO COLLECTING SYRINGE. THE SURGEON ORDERED CT SCAN AND INTRODUCED TPA INTO THE CATHETER ON (B)(6) 2024. THE PUMP WAS EXPLANTED AND REPLACED ON (B)(6) 2024. INTRAOPERATIVELY, THE SURGEON EMPTIED THE PUMP TO DETERMINE IF THE TPA INSTILLED INTO THE CATHETER HAD REINSTATED FLOW. THE PUMP EMPTIED 12 ML. THE SURGEON INDICATED THAT HE HAD IN "AROUND 18-20 ML" ON (B)(6) 2024, WHICH INDICATES THAT THE PUMP WAS FLOWING AND HAD FLOWED APPROXIMATELY 6-8 ML OVER THE 6 DAY PERIOD. NEXT REFILL IS PENDING AND THEREFORE THE DATA ARE NOT AVAILABLE AT THE TIME OF THIS REPORT. HAPS SCAN POST IMPLANT SHOWED NO EXTRAHEPATIC FLOW.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1521323 | INTERA 3000 | HEPATIC ARTERY INFUSION PUMP | LKK | INTERA ONCOLOGY, INC | AP03000H | 28155410S | 00850014110147 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 62 YR | Male | Required Intervention |