Devices › Pump, infusion, elastomeric
Device brand name · Pump infusion elastomeric
Infusor: medical device reports filed with FDA
15,687 reports name it, 1994–2026. Manufacturer given most often on reports: Baxter Healthcare - Irvine. Product code MEB.
- 15,687
- device reports naming the brand
- 0.1% of all MAUDE reports · about 486 a year
- 620
- reports, 12 months to August 2026
- 634 in the 12 months before
- 99.5%
- classified as malfunction
- 90.4% across the product code
- 0%
- classified as death, as reported
- 0 reports · not verified by FDA
FDA's MAUDE database holds 15,687 reports that name the brand "Infusor" (pump infusion elastomeric), received between April 1994 and August 2026; the manufacturer given most often on reports is Baxter Healthcare - Irvine. Spellings of one product vary from report to report.
620 reports arrived in the 12 months to August 2026, close to the 634 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 (99.5%) and injury (0.5%); across all pump, infusion, elastomeric reports (product code MEB) death is recorded in 0.2% and malfunction in 90.4%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are fluid/blood leak (24.2%), filling problem (14.4%) and no flow (13.6%). The patient problems coded most often are no patient involvement, underdose and overdose. 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 33,522 reports carrying product code MEB. 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 |
|---|---|---|---|
| Fluid/blood leak | 3,804 | 24.2% | 19.6% |
| Filling problem | 2,258 | 14.4% | 14.3% |
| No flow | 2,137 | 13.6% | 9.4% |
| Material rupture | 1,780 | 11.3% | 11.2% |
| Device contamination with chemical or other material | 1,578 | 10.1% | 5.6% |
| Leak/splashthe device leaked | 1,008 | 6.4% | 4.7% |
| Breakthe device broke | 435 | 2.8% | 2.9% |
| Insufficient flow or under infusion | 389 | 2.5% | 2.8% |
| Failure to deliverthe device did not deliver the dose or item | 363 | 2.3% | 1.6% |
| Excess flow or over-infusion | 274 | 1.7% | 7.5% |
| Failure to infuse | 250 | 1.6% | 1.9% |
| Loose or intermittent connection | 214 | 1.4% | 0.5% |
| Disconnection | 199 | 1.3% | 0.9% |
| Detachment of device component | 183 | 1.2% | 1% |
| Device operates differently than expectedthe device behaved unexpectedly | 162 | 1% | 0.9% |
| Infusion or flow problema problem with flow or infusion | 149 | 0.9% | 3.7% |
| Improper flow or infusion | 146 | 0.9% | 0.7% |
| Material separation | 141 | 0.9% | 0.5% |
| Component missing | 140 | 0.9% | 0.7% |
| Crackthe device cracked | 140 | 0.9% | 0.8% |
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 |
|---|---|---|
| No patient involvement | 7,192 | 45.8% |
| Underdoseless than the intended dose | 64 | 0.4% |
| Overdosea dose above the recommended amount | 61 | 0.4% |
| Painpain, site not specified | 13 | 0.1% |
| Nauseafeeling sick | 10 | 0.1% |
| Appropriate clinical signs, symptoms and conditions term/code not available | 9 | 0.1% |
| Injurya physical injury | 9 | 0.1% |
| Vomitingbeing sick | 7 | 0% |
| Thromboembolism | 6 | 0% |
| Bacterial infectiona bacterial infection | 4 | 0% |
| Diarrhea | 4 | 0% |
| Dizzinesslight-headedness or unsteadiness | 4 | 0% |
| Dyspneashortness of breath | 4 | 0% |
| Chest painchest pain | 3 | 0% |
| Confusion/ disorientation | 3 | 0% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Infusor | Product code MEB | All MAUDE reports |
|---|---|---|---|
| Reports | 15,687 | 33,522 | 26,136,888 |
| Share of that pool | — | 46.8% | 0.1% |
| Classified as death, per 1,000 reports | 0 | 2 | 9 |
| Classified as injury | 0.5% | 5.9% | 36.2% |
| Classified as malfunction | 99.5% | 90.4% | 62.3% |
| Filed by the manufacturer | 100% | 94.7% | 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 MEB
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| FOLFusor | 7,413 | 525 | 0% |
| Easypump | 738 | 90 | 0.1% |
| On-Q Painbuster | 326 | 0 | 0.6% |
| On-Q Pain Pump | 259 | 0 | 0% |
| On-Q Pump | 228 | 0 | 0.9% |
| Eclipse Homepump | 231 | 0 | 0% |
| Ce Infusor Lv 5 12 Pack | 195 | 0 | 0% |
| Easypump 2 | 170 | 14 | 0% |
| Intermate | 8,261 | 47 | 0% |
| On-Q Silversoaker | 151 | 0 | 0.7% |
| Stryker | 559 | 5 | 1.3% |
| Ce Intermate Lv 100 24 Pack 50126 | 166 | 0 | 0% |
| Ce Intermate Lv 250 24 Pack 50126 | 153 | 0 | 0% |
| Eclipse | 275 | 44 | 0.7% |
| Unknown Catheter | 270 | 26 | 2.2% |
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 Infusor reports
How many FDA reports name Infusor?
15,687 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 620 in the latest 12 months.
What kinds of events are reported?
malfunction (99.5%) and injury (0.5%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
fluid/blood leak (24.2%), filling problem (14.4%), no flow (13.6%), material rupture (11.3%) and device contamination with chemical or other material (10.1%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (100%) and voluntary reports (0%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Infusor 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.