INTERA 3000
Report
- Report Number
- 3015537318-2022-00031
- Event Type
- Malfunction
- Date Received
- December 16, 2022
- Report Date
- February 14, 2023
- Manufacturer
- INTERA ONCOLOGY
- Product Code
- LKK
- UDI-DI
- 00850014110147
- PMA / PMN Number
- P890055
- Removal / Correction Number
- Z-1522-2022
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
DEVICE HISTORY RECORD WAS PREVIOUSLY EVALUATED AND DETERMINED TO BE WITHIN SCOPE OF Z-1522-2022. BLANK FIELDS IN THE MDR REPORT REPRESENTS UNKNOWN INFORMATION. A SUPPLEMENTAL MDR WILL BE FILED UPON CONFIRMATION OF COMPLETED DEVICE REVISION. IF FURTHER INFORMATION IS RECEIVED AT A LATER DATE, A SUPPLEMENTAL MDR WILL BE FILED.
DEVICE EXPLANT WAS CONFIRMED AND RETURNED TO INTERA ON 14 FEBRUARY 2023. DEVICE WAS PREVIOUSLY DETERMINED AND REPORTED TO BE WITHIN SCOPE OF Z-1522-2022.
IT WAS REPORTED BY A HEALTHCARE PROVIDER THAT AN INTERA 3000 HEPATIC ARTERY INFUSION PUMP WAS PRESENTING EMPTY AT MULTIPLE REFILL APPOINTMENTS IMPLANT DATE WAS (B)(6) 2022, WITH AN INTRA-ARTERIAL FLOW RATE AS MANUFACTURED OF 1.1 ML/DAY. IT WAS VERBALLY STATED TO INTERA THAT THE DEVICE REVISION SURGERY WAS PLANNED FOR (B)(6) 2022.
IT WAS REPORTED BY A HEALTHCARE PROVIDER THAT AN INTERA 3000 HEPATIC ARTERY INFUSION PUMP WAS PRESENTING EMPTY AT MULTIPLE REFILL APPOINTMENTS IMPLANT DATE WAS (B)(6) 2022, WITH AN INTRA-ARTERIAL FLOW RATE AS MANUFACTURED OF 1.1 ML/DAY. IT WAS VERBALLY STATED TO INTERA THAT THE DEVICE REVISION SURGERY WAS PLANNED FOR (B)(6) 2022.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1868408 | INTERA 3000 | HEPATIC ARTERY INFUSION PUMP | LKK | INTERA ONCOLOGY | AP03000H | 28432 | 00850014110147 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 39 YR | Female | Required Intervention |