Device brand name · Pump infusion
SIGMA Spectrum Infusion Pump: medical device reports filed with FDA
3,457 reports name it, 2008–2026. Manufacturer given most often on reports: Baxter Healthcare. Product code FRN.
- 3,457
- device reports naming the brand
- 0% of all MAUDE reports · about 194 a year
- 1,128
- reports, 12 months to August 2026
- 1,289 in the 12 months before
- 98.1%
- classified as malfunction
- 98.5% across the product code
- 0.2%
- classified as death, as reported
- 7 reports · not verified by FDA
FDA's MAUDE database holds 3,457 reports that name the brand "SIGMA Spectrum Infusion Pump" (pump infusion), received between September 2008 and August 2026; the manufacturer given most often on reports is Baxter Healthcare. Spellings of one product vary from report to report.
1,128 reports arrived in the 12 months to August 2026, down 12% from 1,289 in 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 (98.1%), injury (1.5%) and death (0.2%); across all pump, infusion reports (product code FRN) death is recorded in 0.1% and malfunction in 98.5%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are protective measures problem (27.8%), failure to sense (15.6%) and false alarm (15.4%). The patient problems coded most often are low blood pressure/ hypotension, overdose and no patient involvement. 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 1,831,109 reports carrying product code FRN. 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 |
|---|---|---|---|
| Protective measures problem | 960 | 27.8% | 0.5% |
| Failure to sense | 539 | 15.6% | 0.9% |
| False alarm | 532 | 15.4% | 0.7% |
| Filling problem | 426 | 12.3% | 0.2% |
| Defective alarm | 350 | 10.1% | 0.2% |
| Complete loss of power | 100 | 2.9% | 0.1% |
| Missing information | 70 | 2% | 0% |
| Excess flow or over-infusion | 68 | 2% | 1.2% |
| Device alarm system | 51 | 1.5% | 2.8% |
| Device displays incorrect message | 42 | 1.2% | 9.3% |
| Insufficient flow or under infusion | 33 | 1% | 0.8% |
| Battery problema problem with the battery | 30 | 0.9% | 1.2% |
| Device operates differently than expectedthe device behaved unexpectedly | 23 | 0.7% | 0.9% |
| No audible prompt/feedback | 21 | 0.6% | 0.1% |
| Improper or incorrect procedure or method | 19 | 0.5% | 0.1% |
| Intermittent loss of power | 19 | 0.5% | 0% |
| Failure to deliverthe device did not deliver the dose or item | 17 | 0.5% | 0.8% |
| Failure to infuse | 17 | 0.5% | 0.4% |
| Loss of powerthe device lost power | 17 | 0.5% | 0.1% |
| Obstruction of flow | 17 | 0.5% | 0.3% |
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 |
|---|---|---|
| Low blood pressure/ hypotension | 23 | 0.7% |
| Overdosea dose above the recommended amount | 15 | 0.4% |
| No patient involvement | 11 | 0.3% |
| Appropriate clinical signs, symptoms and conditions term/code not available | 8 | 0.2% |
| Fatiguetiredness | 7 | 0.2% |
| Underdoseless than the intended dose | 6 | 0.2% |
| Deaththe patient died; cause not stated by this term | 5 | 0.1% |
| High blood pressure/ hypertension | 5 | 0.1% |
| Infiltration into tissue | 5 | 0.1% |
| Cardiac arrestthe heart stopped | 4 | 0.1% |
| Blood loss | 2 | 0.1% |
| Hemodynamic instability | 2 | 0.1% |
| Hemorrhage/blood loss/bleeding | 2 | 0.1% |
| Hypoglycemialow blood sugar | 2 | 0.1% |
| Missed dose | 2 | 0.1% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | SIGMA Spectrum Infusion Pump | Product code FRN | All MAUDE reports |
|---|---|---|---|
| Reports | 3,457 | 1,831,109 | 26,136,888 |
| Share of that pool | — | 0.2% | 0% |
| Classified as death, per 1,000 reports | 2 | 1 | 9 |
| Classified as injury | 1.5% | 1.3% | 36.2% |
| Classified as malfunction | 98.1% | 98.5% | 62.3% |
| Filed by the manufacturer | 94.6% | 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 FRN
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Alaris Pump Module | 684,522 | 0 | 0% |
| Alaris System | 422,501 | 33,692 | 0% |
| 8100 Alaris Pump Module | 163,620 | 0 | 0% |
| Spectrum Infusion Pump | 147,363 | 15 | 0% |
| 8015 Alaris System Pc Unit | 54,162 | 0 | 0% |
| Alaris System Pc Unit | 24,066 | 0 | 0% |
| 8110 Alaris Syringe Pump | 22,434 | 0 | 0% |
| Colleague | 21,763 | 0 | 0% |
| Reservoir 3ML MMT-332A | 19,914 | 2,008 | 0.4% |
| Reservoir 3ml | 16,407 | 0 | 0.8% |
| Flogard | 15,668 | 0 | 0% |
| Colleague Volumetric Infusion Pump | 13,678 | 0 | 0.1% |
| Colleague Pre P1 7 | 13,103 | 0 | 0% |
| CADD-Solis VIP Ambulatory Infusion Pump | 11,721 | 3,471 | 0.1% |
| Intermate | 8,261 | 47 | 0% |
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 SIGMA Spectrum Infusion Pump reports
How many FDA reports name SIGMA Spectrum Infusion Pump?
3,457 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 1,128 in the latest 12 months.
What kinds of events are reported?
malfunction (98.1%), injury (1.5%) and death (0.2%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
protective measures problem (27.8%), failure to sense (15.6%), false alarm (15.4%), filling problem (12.3%) and defective alarm (10.1%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (94.6%) and voluntary reports (0.1%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that SIGMA Spectrum Infusion Pump 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.