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FDA product code LHI · class 2 · General Hospital
Set, i.v. fluid transfer: medical device reports filed with FDA
14,401 reports carry this product code, 1992–2026; 30 brands with a page.
- 14,401
- reports with this product code
- 0.1% of all MAUDE reports
- 1,579
- reports, 12 months to August 2026
- 1,407 in the 12 months before
- 96.3%
- classified as malfunction
- 62.3% across all reports
- 0.1%
- classified as death, as reported
- 0.9% across all reports
Product code LHI is FDA's classification for "Set, i.v. fluid transfer" (general Hospital panel), a class 2 device. 14,401 medical device reports carry this product code, 0.1% of the MAUDE database, from March 1992 to August 2026.
1,579 reports arrived in the 12 months to August 2026, up 12% from 1,407 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 (96.3%), injury (2.4%) and other (0.5%). 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 |
|---|---|---|
| Baxter Healthcare | 6,596 | 45.8% |
| Smiths Medical Asd | 2,499 | 17.4% |
| Baxter Healthcare Round Lake | 1,168 | 8.1% |
| Baxter Healthcare - Malta | 660 | 4.6% |
| Baxter Healthcare - Cleveland | 509 | 3.5% |
| B Braun Medical | 381 | 2.6% |
| Icu Medical Healthcare Manufacturing De C V | 311 | 2.2% |
| Becton Dickinson | 233 | 1.6% |
| Smiths Healthcare Manufacturing De C V | 68 | 0.5% |
| Sistemas Medicos Alaris De C V | 49 | 0.3% |
| B Braun Melsungen | 32 | 0.2% |
| Icu Medical | 31 | 0.2% |
| Bd | 23 | 0.2% |
| Baxter International | 22 | 0.2% |
| Abbott Laboratories | 17 | 0.1% |
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 |
|---|---|---|
| Fluid/blood leak | 6,594 | 45.8% |
| Device contamination with chemical or other material | 2,906 | 20.2% |
| Leak/splashthe device leaked | 660 | 4.6% |
| Disconnection | 405 | 2.8% |
| Infusion or flow problema problem with flow or infusion | 265 | 1.8% |
| Device displays incorrect message | 264 | 1.8% |
| Air/gas in device | 259 | 1.8% |
| Breakthe device broke | 258 | 1.8% |
| Contamination /decontamination problem | 231 | 1.6% |
| Device operates differently than expectedthe device behaved unexpectedly | 212 | 1.5% |
| Material puncture/hole | 155 | 1.1% |
| Protective measures problem | 141 | 1% |
| Defective devicethe device was defective | 136 | 0.9% |
| Overdelivery | 118 | 0.8% |
| Fitting problem | 108 | 0.7% |
| No flow | 105 | 0.7% |
| Contamination | 104 | 0.7% |
| Defective component | 95 | 0.7% |
| Device alarm system | 94 | 0.7% |
| Free or unrestricted flow | 84 | 0.6% |
Questions about set, i.v. fluid transfer reports
What is product code LHI?
FDA's classification code for "Set, i.v. fluid transfer", 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?
14,401 reports through August 2026, 1,579 of them in the latest 12 months.
Which brands appear most often?
Exactamix (2,255), Exactamix Tubing Sets For Baxa Exacta-Med Pharmacy Pump (1,262), 2000 Ml Tpn Bag (1,163), Ivt Disposable (870) and 500 Ml Tpn Bag (706). 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.