Devices › Pump, infusion, implanted, programmable
Device brand name · Hepatic artery infusion pump
Intera 3000: medical device reports filed with FDA
307 reports name it, 2022–2026. Product code LKK.
- 307
- device reports naming the brand
- 0% of all MAUDE reports · about 70 a year
- 99
- reports, 12 months to August 2026
- 104 in the 12 months before
- 62.9%
- classified as malfunction
- 32.6% across the product code
- 0%
- classified as death, as reported
- 0 reports · not verified by FDA
307 medical device reports received by FDA name the brand "Intera 3000" (hepatic artery infusion pump); received from February 2022 to July 2026. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.
99 reports arrived in the 12 months to August 2026, close to the 104 of the 12 months before. FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases. The event types recorded are malfunction (62.9%) and injury (37.1%); across all pump, infusion, implanted, programmable reports (product code LKK) death is recorded in 1.4% and malfunction in 32.6%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are no flow (16%), insufficient flow or under infusion (15.3%) and excess flow or over-infusion (9.8%). The patient problems coded most often are bacterial infection, reaction to medicinal component of device and seroma. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data."
Reports by month, five years
Reports by the month FDA received them. FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases.
By year received
Event type and report source
Event type, as classified on the report
Who filed the report
Grey bar: all 117,271 reports carrying product code LKK. Event type is the filer's classification and is not verified by FDA.
Device problems coded
| Device problem (FDA code) | Reports | Share | Share across product code |
|---|---|---|---|
| No flow | 49 | 16% | 0.1% |
| Insufficient flow or under infusion | 47 | 15.3% | 6.7% |
| Excess flow or over-infusion | 30 | 9.8% | 1.9% |
| Difficult to flush | 19 | 6.2% | 0% |
| Insufficient device problem information | 19 | 6.2% | 7% |
| Improper flow or infusion | 16 | 5.2% | 0.6% |
| Obstruction of flow | 14 | 4.6% | 2.8% |
| Inaccurate delivery | 12 | 3.9% | 0.1% |
| Migrationthe device moved from where it was placed | 12 | 3.9% | 0.1% |
| Improper or incorrect procedure or method | 11 | 3.6% | 4% |
| Infusion or flow problema problem with flow or infusion | 11 | 3.6% | 4.8% |
| Fluid/blood leak | 9 | 2.9% | 2.1% |
| Filling problem | 5 | 1.6% | 2.5% |
| Device difficult to setup or prepare | 4 | 1.3% | 0% |
| Compatibility problem | 2 | 0.7% | 0% |
| Defective component | 2 | 0.7% | 0.1% |
| Device contamination with chemical or other material | 2 | 0.7% | 0% |
| Failure to infuse | 2 | 0.7% | 0.2% |
| Microbial contamination of device | 2 | 0.7% | 0% |
| Component missing | 1 | 0.3% | 0% |
FDA's device problem codes as entered on the report; one report can carry several. Generic codes such as "no apparent adverse event" are left out.
Patient problems coded
| Patient problem (FDA code) | Reports | Share |
|---|---|---|
| Bacterial infectiona bacterial infection | 17 | 5.5% |
| Reaction to medicinal component of device | 14 | 4.6% |
| Seromaa collection of fluid under the skin | 11 | 3.6% |
| Thrombosis/thrombus | 10 | 3.3% |
| Hematomaa collection of blood under the skin or in tissue | 7 | 2.3% |
| Pseudoaneurysm | 7 | 2.3% |
| Failure of implant | 6 | 2% |
| Painpain, site not specified | 5 | 1.6% |
| Wound dehiscencea wound reopened | 5 | 1.6% |
| Abdominal painstomach or belly pain | 4 | 1.3% |
| Pocket erosion | 4 | 1.3% |
| Ascitesfluid in the abdomen | 3 | 1% |
| Cholangitis | 3 | 1% |
| Extravasation | 3 | 1% |
| Fever | 3 | 1% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Intera 3000 | Product code LKK | All MAUDE reports |
|---|---|---|---|
| Reports | 307 | 117,271 | 26,136,888 |
| Share of that pool | — | 0.3% | 0% |
| Classified as death, per 1,000 reports | 0 | 14 | 9 |
| Classified as injury | 37.1% | 64% | 36.2% |
| Classified as malfunction | 62.9% | 32.6% | 62.3% |
| Filed by the manufacturer | 99.7% | 99.1% | 94.9% |
Shares are of reports, not of devices in use. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data."
Other brands with product code LKK
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Synchromed El | 7,189 | 2 | 4.9% |
| Synchromed | 3,429 | 3 | 3.2% |
| Indura | 2,730 | 0 | 0.8% |
| Intrathecal Catheter | 696 | 18 | 0.1% |
| Implantable Drug Infusion Pump | 649 | 177 | 0.9% |
| Ascenda | 570 | 14 | 0.9% |
| Infusion Pump | 830 | 6 | 3.7% |
| Indura Catheter | 373 | 0 | 0% |
| Prometra Programmable Pump | 348 | 0 | 6.6% |
| Isomed | 281 | 1 | 2.5% |
| Unknown Implantable Pump | 233 | 0 | 2.6% |
| N'vision | 269 | 0 | 0.7% |
| Implantable Infusion Pump | 211 | 0 | 3.8% |
| Unknown Infusion Pump | 157 | 0 | 1.9% |
| Catheter | 244 | 9 | 3.7% |
Ordered by report count for navigation only. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data." FDA also states that "common products may have a higher number of adverse events due to the higher total number of people using the product."
Questions about Intera 3000 reports
How many FDA reports name Intera 3000?
307 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 99 in the latest 12 months.
What kinds of events are reported?
malfunction (62.9%) and injury (37.1%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
no flow (16%), insufficient flow or under infusion (15.3%), excess flow or over-infusion (9.8%), difficult to flush (6.2%) and insufficient device problem information (6.2%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (99.7%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Intera 3000 was at fault?
No. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data." FDA adds that "a causal relationship cannot be established between product and reactions listed in a report."
How do I report a problem with a medical device?
Through FDA MedWatch (Form FDA 3500 for health professionals and consumers), or to the manufacturer. See the guide on how to report.
Where this comes from. Counts are built from the openFDA Device Adverse Event (MAUDE) bulk export released 28 Sep 2026, which holds reports FDA received through 31 Aug 2026. Brand, generic and manufacturer names are as written on the reports; product code names come from FDA's device classification. A report counts here when any device it lists carries this brand name after punctuation and capitalisation are normalised. No report narrative, lot number, patient detail or reporter identity is published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.
Drug data (FAERS) through 30 Jun 2026; device data (MAUDE) through 31 Aug 2026. Not medical advice.