BD Pyxis MedStation 4000: medical device reports filed with FDA

483 reports name it, 2024–2026. Manufacturer given most often on reports: Carefusion 303. Product code BRY.

Read first · FDA's statement on these data

Adverse event reports submitted to FDA do not undergo extensive validation or verification. Therefore, a causal relationship cannot be established between product and reactions listed in a report. While a suspected relationship may exist, it is not medically validated and should not be the sole source of information for clinical decision making or other assumptions about the safety or efficacy of a product. Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product. openFDA, FDA

FDA adds: "Although MDRs are a valuable source of information, this passive surveillance system has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data. In addition, the incidence or prevalence of an event cannot be determined from this reporting system alone due to potential under-reporting of events and lack of information about frequency of device use." And: "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."

Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated.

Not medical advice. This site counts what was reported to FDA. Questions about a medicine or device belong with a pharmacist or clinician.

483
device reports naming the brand: 0% of all MAUDE reports · about 277 a year; 284
reports, 12 months to August 2026: 199 in the 12 months before; 100%
classified as malfunction: 99.9% across the product code; 0%
classified as death, as reported: 0 reports · not verified by FDA

FDA's MAUDE database holds 483 reports that name the brand "BD Pyxis MedStation 4000" (automated dispensing cabinet), received between October 2024 and August 2026; the manufacturer given most often on reports is Carefusion 303. Spellings of one product vary from report to report.

284 reports arrived in the 12 months to August 2026, up 43% from 199 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 cabinet, table and tray, anesthesia reports (product code BRY) death is recorded in 0% and malfunction in 99.9%. Event type is the reporter's classification of the report, not a verified outcome.

The device problems coded most often are computer software problem (23%), failure to eject (19.9%) and mechanical problem (10.8%). 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

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

Death0%0

Injury0%0

Malfunction100%483

Other0%0

Not given0%0

Who filed the report

Manufacturer report100%483

Voluntary report0%0

User facility report0%0

Distributor report0%0

Not given0%0

Grey bar: all 103,373 reports carrying product code BRY. 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
Computer software problema software problem	111	23%	11%
Failure to eject	96	19.9%	5.1%
Mechanical problema mechanical problem	52	10.8%	22.4%
Communication or transmission problemthe device could not communicate or transmit	35	7.2%	4.1%
Application program problem	28	5.8%	10.1%
Application program freezes or fails to launch	22	4.6%	2.6%
Electrical /electronic property probleman electrical or electronic problem	19	3.9%	7.6%
Circuit failure	17	3.5%	8.1%
Activation failure	16	3.3%	5.7%
Breakthe device broke	16	3.3%	6.4%
Leak/splashthe device leaked	15	3.1%	0.3%
Loose or intermittent connection	13	2.7%	9.4%
Computer operating system problem	10	2.1%	0.3%
Installation-related problem	10	2.1%	2.8%
Labelling, instructions for use or training problem	9	1.9%	4.7%
Date/time-related software problem	8	1.7%	0.4%
Contamination	7	1.4%	2.6%
Mechanical jam	7	1.4%	2.4%
Ejection problem	6	1.2%	0.2%
Application network problem	5	1%	2.9%

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

Measure	BD Pyxis MedStation 4000	Product code BRY	All MAUDE reports
Reports	483	103,373	26,136,888
Share of that pool	—	0.5%	0%
Classified as death, per 1,000 reports	0	0	9
Classified as injury	0%	0.1%	36.2%
Classified as malfunction	100%	99.9%	62.3%
Filed by the manufacturer	100%	99.9%	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 BRY

Brand	Reports	Latest 12 months	Classified as death
BD Pyxis MedStation ES	49,097	33,499	0%
BD Pyxis MedStation ES Auxiliary	14,382	9,862	0%
BD Pyxis Anesthesia Station ES	6,844	4,515	0%
Pyxis Medstation Es System	6,114	0	0%
BD Pyxis MedStation ES Auxiliary Tower	5,488	3,659	0%
BD Pyxis ES Server	5,487	4,442	0%
BD Pyxis MedBank Tower	4,510	3,170	0%
BD Pyxis ES Refrigerator	1,258	949	0%
BD Pyxis MedBank Mini	1,067	768	0%
Pyxis Medstation System	977	0	0%
BD Pyxis MedStation ES Tower	905	634	0%
BD Pyxis Medflex 1000	890	676	0%
Pyxis Anesthesia System Pas	805	0	0%
BD Pyxis MedBank Tower Aux	472	300	0%
Bd Pyxis Medstation Es System	427	5	0.2%

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 BD Pyxis MedStation 4000 reports

How many FDA reports name BD Pyxis MedStation 4000?

483 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 284 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?

computer software problem (23%), failure to eject (19.9%), mechanical problem (10.8%), communication or transmission problem (7.2%) and application program problem (5.8%). 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 BD Pyxis MedStation 4000 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.