Device brand name · Pump infusion
PLUM 360 Infuser: medical device reports filed with FDA
507 reports name it, 2020–2026. Manufacturer given most often on reports: Icu Medical Costa Rica. Product code FRN.
- 507
- device reports naming the brand
- 0% of all MAUDE reports · about 78 a year
- 79
- reports, 12 months to August 2026
- 87 in the 12 months before
- 91.1%
- classified as malfunction
- 98.5% across the product code
- 3.2%
- classified as death, as reported
- 16 reports · not verified by FDA
507 medical device reports received by FDA name the brand "PLUM 360 Infuser" (pump infusion); the manufacturer given most often on reports is Icu Medical Costa Rica; received from January 2020 to August 2026. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.
79 reports arrived in the 12 months to August 2026, close to the 87 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 (91.1%), injury (5.7%) and death (3.2%); 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 unexpected shutdown (22.5%), inaccurate delivery (14.6%) and infusion or flow problem (12.2%). The patient problems coded most often are low blood pressure/ hypotension, cardiac arrest and cardiopulmonary arrest. 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 |
|---|---|---|---|
| Unexpected shutdown | 114 | 22.5% | 0.1% |
| Inaccurate delivery | 74 | 14.6% | 0.4% |
| Infusion or flow problema problem with flow or infusion | 62 | 12.2% | 0.3% |
| Inaccurate flow rate | 48 | 9.5% | 0.1% |
| Battery problema problem with the battery | 47 | 9.3% | 1.2% |
| Air/gas in device | 37 | 7.3% | 0.1% |
| Excess flow or over-infusion | 32 | 6.3% | 1.2% |
| No audible alarm | 24 | 4.7% | 0.2% |
| Smoking | 24 | 4.7% | 0% |
| Corrodedthe device corroded | 20 | 3.9% | 11.6% |
| Electrical /electronic property probleman electrical or electronic problem | 11 | 2.2% | 0.8% |
| Unintended application program shut down | 11 | 2.2% | 0% |
| Failure to deliverthe device did not deliver the dose or item | 9 | 1.8% | 0.8% |
| Insufficient flow or under infusion | 9 | 1.8% | 0.8% |
| Pumping stopped | 8 | 1.6% | 0.2% |
| Failure to infuse | 6 | 1.2% | 0.4% |
| Free or unrestricted flow | 6 | 1.2% | 0.1% |
| Volume accuracy problem | 6 | 1.2% | 0.1% |
| Device emits odor | 4 | 0.8% | 0% |
| Device sensing problem | 4 | 0.8% | 3.8% |
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 |
|---|---|---|
| Low blood pressure/ hypotension | 21 | 4.1% |
| Cardiac arrestthe heart stopped | 12 | 2.4% |
| Cardiopulmonary arrest | 5 | 1% |
| Chest painchest pain | 4 | 0.8% |
| Bradycardiaslow heart rate | 3 | 0.6% |
| Missed dose | 3 | 0.6% |
| Respiratory arrestbreathing stopped | 3 | 0.6% |
| Tachycardiafast heart rate | 3 | 0.6% |
| Appropriate clinical signs, symptoms and conditions term/code not available | 2 | 0.4% |
| Deaththe patient died; cause not stated by this term | 2 | 0.4% |
| High blood pressure/ hypertension | 2 | 0.4% |
| Air embolism | 1 | 0.2% |
| Angina | 1 | 0.2% |
| Apnea | 1 | 0.2% |
| Awareness during anesthesia | 1 | 0.2% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | PLUM 360 Infuser | Product code FRN | All MAUDE reports |
|---|---|---|---|
| Reports | 507 | 1,831,109 | 26,136,888 |
| Share of that pool | — | 0% | 0% |
| Classified as death, per 1,000 reports | 32 | 1 | 9 |
| Classified as injury | 5.7% | 1.3% | 36.2% |
| Classified as malfunction | 91.1% | 98.5% | 62.3% |
| Filed by the manufacturer | 99.4% | 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 PLUM 360 Infuser reports
How many FDA reports name PLUM 360 Infuser?
507 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 79 in the latest 12 months.
What kinds of events are reported?
malfunction (91.1%), injury (5.7%) and death (3.2%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
unexpected shutdown (22.5%), inaccurate delivery (14.6%), infusion or flow problem (12.2%), inaccurate flow rate (9.5%) and battery problem (9.3%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (99.4%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that PLUM 360 Infuser 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.