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FDA product code MEA · class 2 · General Hospital
Pump, infusion, pca: medical device reports filed with FDA
32,877 reports carry this product code, 1992–2026; 30 brands with a page.
- 32,877
- reports with this product code
- 0.1% of all MAUDE reports
- 2,829
- reports, 12 months to August 2026
- 4,398 in the 12 months before
- 95.6%
- classified as malfunction
- 62.3% across all reports
- 0.7%
- classified as death, as reported
- 0.9% across all reports
Product code MEA is FDA's classification for "Pump, infusion, pca" (general Hospital panel), a class 2 device. 32,877 medical device reports carry this product code, 0.1% of the MAUDE database, from March 1992 to August 2026.
2,829 reports arrived in the 12 months to August 2026, down 36% from 4,398 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 (95.6%), injury (2.6%) and other (0.9%). 30 brand names with a page on this site carry this code; the brands table is 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."
Brands with this product code
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."
Manufacturers named
| Manufacturer (as written on reports) | Reports | Share |
|---|---|---|
| Carefusion Sd | 16,685 | 50.7% |
| Smiths Medical Asd | 5,365 | 16.3% |
| Icu Medical | 2,658 | 8.1% |
| Baxter Healthcare Pte | 1,384 | 4.2% |
| St Paul | 1,190 | 3.6% |
| Hospira | 942 | 2.9% |
| Abbott Laboratories | 893 | 2.7% |
| Hospira Costa Rica | 718 | 2.2% |
| Baxter Healthcare Sg | 387 | 1.2% |
| Baxter Healthcare | 322 | 1% |
| Carefusion 303 | 278 | 0.8% |
| Smith S Medical Asd | 188 | 0.6% |
| Baxter Healthcare - Irvine | 150 | 0.5% |
| B Braun Melsungen | 125 | 0.4% |
| Smiths Medical | 112 | 0.3% |
Reports by month, five years
FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases.
Event type and report source
Event type
Who filed
Grey bar: all 26,136,888 MAUDE reports.
Device problems coded
| Device problem (FDA code) | Reports | Share |
|---|---|---|
| Breakthe device broke | 6,624 | 20.1% |
| Crackthe device cracked | 4,971 | 15.1% |
| Corrodedthe device corroded | 4,071 | 12.4% |
| Device markings/labelling problema problem with the device markings or label | 3,948 | 12% |
| Failure to align | 2,523 | 7.7% |
| Failure to infuse | 1,854 | 5.6% |
| Contamination | 1,819 | 5.5% |
| Device alarm system | 1,788 | 5.4% |
| Device sensing problem | 1,763 | 5.4% |
| Deformation due to compressive stress | 1,755 | 5.3% |
| Excess flow or over-infusion | 1,488 | 4.5% |
| Device displays incorrect message | 1,487 | 4.5% |
| Inaccurate delivery | 1,049 | 3.2% |
| Physical resistance/sticking | 903 | 2.7% |
| Failure to sense | 883 | 2.7% |
| Degraded | 775 | 2.4% |
| Naturally worn | 754 | 2.3% |
| Failure to calibrate | 698 | 2.1% |
| Circuit failure | 609 | 1.9% |
| Display difficult to read | 582 | 1.8% |
Questions about pump, infusion, pca reports
What is product code MEA?
FDA's classification code for "Pump, infusion, pca", class 2, reviewed by the general Hospital panel. Every device report carries the product code of the device involved.
How many reports carry this code?
32,877 reports through August 2026, 2,829 of them in the latest 12 months.
Which brands appear most often?
Alaris System (10,265), 8120 Alaris Pca (5,671), CADD Solis HPCA Pump (2,722), CADD-Solis Ambulatory Infusion Pump (1,723) and Ipump Pain Management System (961). Widely used products collect more reports because more people use them.
Can the brands table be used to rank the devices?
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." Brands differ in how many are in use, how long they have been sold and how reports are collected.
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. 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.