INTERA 3000
Report
- Report Number
- 3015537318-2025-00079
- Event Type
- Injury
- Date Received
- September 4, 2025
- Date of Event
- August 6, 2025
- Report Date
- September 18, 2025
- Manufacturer
- INTERA ONCOLOGY, INC
- Product Code
- LKK
- UDI-DI
- 00850014110147
- PMA / PMN Number
- P890055
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TN, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
A DEVICE HISTORY REVIEW WAS PERFORMED AND CONFIRMED THIS DEVICE MET MANUFACTURING SPECIFICATIONS PRIOR TO DISTRIBUTION AND THERE WERE NO MANUFACTURING DEVIATIONS THAT COULD HAVE CONTRIBUTED TO THE REPORTED EVENT. THE PHYSICIAN CONFIRMED THAT THE REMOVAL OF THE PUMP WAS NOT RELATED TO PUMP PERFORMANCE AND WAS DUE TO PATIENT'S ANATOMY.
THE PHYSICIAN CONFIRMED THAT THE REMOVAL OF THE PUMP WAS NOT RELATED TO PUMP PERFORMANCE AND WAS DUE TO PATIENT'S ANATOMY. INTERA ONCOLOGY HAS ASKED ITS CONTRACT MANUFACTURER TO PROVIDE US WITH A COPY OF THE PUMP'S DEVICE HISTORY RECORD (DHR) TO CONFIRM THAT THE DEVICE MET MANUFACTURING SPECIFICATIONS PRIOR TO DISTRIBUTION AND THERE WERE NO MANUFACTURING DEVIATIONS. ONCE WE RECEIVE AND REVIEW THE DHR, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
INTERA ONCOLOGY WAS INFORMED BY A PHYSICIAN THAT PUMP SERIAL NUMBER (B)(6) WAS REMOVED ON (B)(6) 2025, DUE TO THE PATIENT NEEDING TO REPAIR THE GASTRODUODENAL ARTERY (GDA). ACCORDING TO THE PHYSICIAN, THERE WAS NO ISSUE WITH THE PUMP, AND IT WAS DUE TO PATIENT'S ANATOMY. A VASCULAR SURGEON WAS BROUGHT IN TO HARVEST A VEIN FROM THE LEG AND USE THAT TO REPAIR THE GDA. WHILE REPAIRING THE GDA, THE CATHETER FOR PUMP SERIAL NUMBER (B)(6) COULD NOT BE SALVAGED. THE PHYSICIAN OPTED TO REPLACE THE ENTIRE PUMP AND CATHETER. ON (B)(6) 2025, NEW PUMP SERIAL NUMBER (B)(6) WAS IMPLANTED. THE PHYSICIAN DID NOT WANT TO SEND THE REMOVED PUMP BACK TO INTERA BECAUSE THERE WAS NOTHING WRONG WITH THE PUMP.
INTERA ONCOLOGY WAS INFORMED BY A PHYSICIAN THAT PUMP SERIAL NUMBER (B)(6) WAS REMOVED ON (B)(6) 2025, DUE TO THE PATIENT NEEDING TO REPAIR THE GASTRODUODENAL ARTERY (GDA). ACCORDING TO THE PHYSICIAN, THERE WAS NO ISSUE WITH THE PUMP, AND IT WAS DUE TO PATIENT'S ANATOMY. A VASCULAR SURGEON WAS BROUGHT IN TO HARVEST A VEIN FROM THE LEG AND USE THAT TO REPAIR THE GDA. WHILE REPAIRING THE GDA, THE CATHETER FOR PUMP SERIAL NUMBER (B)(6) COULD NOT BE SALVAGED. THE PHYSICIAN OPTED TO REPLACE THE ENTIRE PUMP AND CATHETER. ON (B)(6) 2025, NEW PUMP SERIAL NUMBER (B)(6) WAS IMPLANTED. THE PHYSICIAN DID NOT WANT TO SEND THE REMOVED PUMP BACK TO INTERA BECAUSE THERE WAS NOTHING WRONG WITH THE PUMP.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2255677 | INTERA 3000 | HEPATIC ARTERY INFUSION PUMP | LKK | INTERA ONCOLOGY, INC | AP-03000H | 30945454 | 00850014110147 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 55 YR | Male | Required Intervention |