Device brand name · Pump infusion
Alaris Pca: medical device reports filed with FDA
1,707 reports name it, 2019–2022. Manufacturer given most often on reports: Carefusion Sd. Product code MEA.
- 1,707
- device reports naming the brand
- 0% of all MAUDE reports · about 241 a year
- 0
- reports, 12 months to August 2026
- 0 in the 12 months before
- 99.7%
- classified as malfunction
- 95.6% across the product code
- 0.1%
- classified as death, as reported
- 1 reports · not verified by FDA
1,707 medical device reports received by FDA name the brand "Alaris Pca" (pump infusion); the manufacturer given most often on reports is Carefusion Sd; received from June 2019 to October 2022. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.
0 reports arrived in the 12 months to August 2026, and none 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 (99.7%), injury (0.2%) and death (0.1%); across all pump, infusion, pca reports (product code MEA) death is recorded in 0.7% and malfunction in 95.6%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are device sensing problem (39%), display or visual feedback problem (19.3%) and failure to align (12.5%). The patient problems coded most often are no patient involvement, anxiety and appropriate clinical signs, symptoms and conditions term/code not available. 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 32,877 reports carrying product code MEA. 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 |
|---|---|---|---|
| Device sensing problem | 665 | 39% | 5.4% |
| Display or visual feedback problem | 330 | 19.3% | 0.8% |
| Failure to align | 213 | 12.5% | 7.7% |
| Breakthe device broke | 191 | 11.2% | 20.1% |
| Crackthe device cracked | 139 | 8.1% | 15.1% |
| Device markings/labelling problema problem with the device markings or label | 78 | 4.6% | 12% |
| Failure to read input signal | 65 | 3.8% | 0.8% |
| Display difficult to read | 64 | 3.7% | 1.8% |
| Corrodedthe device corroded | 41 | 2.4% | 12.4% |
| Misassembled | 39 | 2.3% | 1.1% |
| Calibration problem | 35 | 2.1% | 1.5% |
| Deformation due to compressive stress | 32 | 1.9% | 5.3% |
| Contamination | 28 | 1.6% | 5.5% |
| Device alarm system | 25 | 1.5% | 5.4% |
| Physical resistance/sticking | 22 | 1.3% | 2.7% |
| Inaccurate delivery | 17 | 1% | 3.2% |
| Failure to power up | 15 | 0.9% | 0.1% |
| Insufficient device problem information | 15 | 0.9% | 1.1% |
| Device slipped | 11 | 0.6% | 0% |
| Failure to cycle | 10 | 0.6% | 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 |
|---|---|---|
| No patient involvement | 1,274 | 74.6% |
| Anxietyanxiety | 1 | 0.1% |
| Appropriate clinical signs, symptoms and conditions term/code not available | 1 | 0.1% |
| Bradycardiaslow heart rate | 1 | 0.1% |
| Deaththe patient died; cause not stated by this term | 1 | 0.1% |
| Fetal distress | 1 | 0.1% |
| Increased respiratory rate | 1 | 0.1% |
| Low blood pressure/ hypotension | 1 | 0.1% |
| Painpain, site not specified | 1 | 0.1% |
| Therapeutic response, increased | 1 | 0.1% |
| Weakness | 1 | 0.1% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Alaris Pca | Product code MEA | All MAUDE reports |
|---|---|---|---|
| Reports | 1,707 | 32,877 | 26,136,888 |
| Share of that pool | — | 5.2% | 0% |
| Classified as death, per 1,000 reports | 1 | 7 | 9 |
| Classified as injury | 0.2% | 2.6% | 36.2% |
| Classified as malfunction | 99.7% | 95.6% | 62.3% |
| Filed by the manufacturer | 100% | 96.4% | 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 MEA
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Alaris System | 422,501 | 33,692 | 0% |
| 8120 Alaris Pca | 6,258 | 0 | 0% |
| CADD Solis HPCA Pump | 2,846 | 1,183 | 0.1% |
| CADD-Solis Ambulatory Infusion Pump | 1,974 | 151 | 0.3% |
| Ipump Pain Management System | 1,018 | 0 | 0.5% |
| Lifecare Pca Plus Infuser | 757 | 0 | 6.9% |
| CADD-Solis HCPA Pump | 735 | 33 | 0% |
| CADD-Solis HPCA Pump | 672 | 224 | 0% |
| Cadd-Legacy Pca Ambulatory Infusion Pump | 436 | 8 | 1.1% |
| CADD Solis HPCA Pumps | 391 | 145 | 0% |
| Pca Empty Sterile | 349 | 0 | 0% |
| Cadd | 10,811 | 9 | 0.1% |
| CADD Legacy PCA Pump | 349 | 71 | 0% |
| Alaris Pca Module | 879 | 0 | 3.1% |
| CADD Legacy PCA Pumps | 250 | 116 | 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 Alaris Pca reports
How many FDA reports name Alaris Pca?
1,707 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 0 in the latest 12 months.
What kinds of events are reported?
malfunction (99.7%), injury (0.2%) and death (0.1%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
device sensing problem (39%), display or visual feedback problem (19.3%), failure to align (12.5%), break (11.2%) and crack (8.1%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (100%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Alaris Pca 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.