Reported Reactions

Devices › Set, i.v. fluid transfer

Device brand name · Set i v fluid transfer

Exactamix Tubing Sets For Baxa Exacta-Med Pharmacy Pump: medical device reports filed with FDA

1,263 reports name it, 2021–2024. Manufacturer given most often on reports: Baxter Healthcare. Product code LHI.

1,263
device reports naming the brand
0% of all MAUDE reports · about 257 a year
0
reports, 12 months to August 2026
0 in the 12 months before
100%
classified as malfunction
96.3% across the product code
0%
classified as death, as reported
0 reports · not verified by FDA

FDA's MAUDE database holds 1,263 reports that name the brand "Exactamix Tubing Sets For Baxa Exacta-Med Pharmacy Pump" (set i v fluid transfer), received between August 2021 and May 2024; the manufacturer given most often on reports is Baxter Healthcare. Spellings of one product vary from report to report.

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 (100%); across all set, i.v. fluid transfer reports (product code LHI) death is recorded in 0.1% and malfunction in 96.3%. Event type is the reporter's classification of the report, not a verified outcome.

The device problems coded most often are fluid/blood leak (60.5%), device contamination with chemical or other material (38.6%) and material puncture/hole (1.8%). 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

03264Sep 2021: 0Oct 2021: 9Nov 2021: 27Dec 2021: 242022Jan 2022: 31Feb 2022: 23Mar 2022: 41Apr 2022: 31May 2022: 13Jun 2022: 35Jul 2022: 43Aug 2022: 40Sep 2022: 30Oct 2022: 38Nov 2022: 58Dec 2022: 452023Jan 2023: 57Feb 2023: 48Mar 2023: 60Apr 2023: 46May 2023: 52Jun 2023: 36Jul 2023: 44Aug 2023: 39Sep 2023: 56Oct 2023: 44Nov 2023: 57Dec 2023: 642024Jan 2024: 28Feb 2024: 57Mar 2024: 52Apr 2024: 26May 2024: 8Jun 2024: 0Jul 2024: 0Aug 2024: 0Sep 2024: 0Oct 2024: 0Nov 2024: 0Dec 2024: 02025Jan 2025: 0Feb 2025: 0Mar 2025: 0Apr 2025: 0May 2025: 0Jun 2025: 0Jul 2025: 0Aug 2025: 0Sep 2025: 0Oct 2025: 0Nov 2025: 0Dec 2025: 02026Jan 2026: 0Feb 2026: 0Mar 2026: 0Apr 2026: 0May 2026: 0Jun 2026: 0Jul 2026: 0Aug 2026: 0

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

03026032021: 6120212022: 42820222023: 60320232024: 1712024

Event type and report source

Event type, as classified on the report

Death0%0
Injury0%0
Malfunction100%1,263
Other0%0
Not given0%0

Who filed the report

Manufacturer report100%1,263
Voluntary report0%0
User facility report0%0
Distributor report0%0
Not given0%0

Grey bar: all 14,401 reports carrying product code LHI. Event type is the filer's classification and is not verified by FDA.

Device problems coded

Device problem (FDA code)ReportsShareShare across product code
Fluid/blood leak76460.5%45.8%
Device contamination with chemical or other material48838.6%20.2%
Material puncture/hole231.8%1.1%
Breakthe device broke70.6%1.8%
Loose or intermittent connection40.3%0.5%
Material rupture30.2%0.2%
Component misassembled20.2%0%
Detachment of device or device componentpart of the device came off20.2%0.5%
Material split, cut or torn20.2%0.1%
Contamination10.1%0.7%
Defective component10.1%0.7%
Material opacification10.1%0.1%
Microbial contamination of device10.1%0%
Precipitate in device or device ingredient10.1%0.1%
Product quality problem10.1%0.1%
Structural problem10.1%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.

In context

MeasureExactamix Tubing Sets For Baxa Exacta-Med Pharmacy PumpProduct code LHIAll MAUDE reports
Reports1,26314,40126,136,888
Share of that pool—8.8%0%
Classified as death, per 1,000 reports019
Classified as injury0%2.4%36.2%
Classified as malfunction100%96.3%62.3%
Filed by the manufacturer100%84.6%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 LHI

BrandReportsLatest 12 monthsClassified as death
Exactamix2,3308110%
2000 Ml Tpn Bag1,16300%
Ivt Disposable4,23800%
500 Ml Tpn Bag70800%
3000 Ml Tpn Bag68500%
Cassette Medi Reservoir708390.3%
1000 Ml Tpn Bag58300%
250 Ml Tpn Bag56500%
Valve Set Em240045000%
Cadd Cassette 100ml W/Flowstop39000%
Vial-Mate Reconstitution Device35200%
Cadd Cassette Reservoirs - Flow Stop Nrfit2111940%
Automix 3+3 Compounder18700.5%
CADD Medication Cassettes Ambulatory Pump Disposals1741740%
B Braun270123%

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 Exactamix Tubing Sets For Baxa Exacta-Med Pharmacy Pump reports

How many FDA reports name Exactamix Tubing Sets For Baxa Exacta-Med Pharmacy Pump?

1,263 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 (100%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.

What device problems are coded?

fluid/blood leak (60.5%), device contamination with chemical or other material (38.6%), material puncture/hole (1.8%), break (0.6%) and loose or intermittent connection (0.3%). 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 Exactamix Tubing Sets For Baxa Exacta-Med Pharmacy 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.