Pump, infusion: medical device reports filed with FDA

1,831,109 reports carry this product code, 1991–2026; 30 brands with a page.

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.

1,831,109
reports with this product code: 7% of all MAUDE reports; 52,891
reports, 12 months to August 2026: 54,106 in the 12 months before; 98.5%
classified as malfunction: 62.3% across all reports; 0.1%
classified as death, as reported: 0.9% across all reports

Product code FRN is FDA's classification for "Pump, infusion" (general Hospital panel), a class 2 device. 1,831,109 medical device reports carry this product code, 7% of the MAUDE database, from December 1991 to August 2026.

52,891 reports arrived in the 12 months to August 2026, close to the 54,106 of 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 (98.5%), injury (1.3%) and death (0.1%). 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

Brand	Reports	Latest 12 months	Classified as death	Classified as malfunction
Alaris Pump Module	684,494	0	0%	99.7%
Alaris System	405,159	33,692	0%	99.7%
8100 Alaris Pump Module	163,612	0	0%	100%
Spectrum Infusion Pump	147,353	15	0%	99.7%
8015 Alaris System Pc Unit	54,161	0	0%	100%
Alaris System Pc Unit	24,064	0	0%	99.9%
8110 Alaris Syringe Pump	22,433	0	0%	100%
Colleague	21,756	0	0%	99.8%
Reservoir 3ML MMT-332A	19,914	2,008	0.4%	67.2%
Reservoir 3ml	16,400	0	0.8%	71.8%
Flogard	15,639	0	0%	99.9%
Colleague Volumetric Infusion Pump	13,665	0	0.1%	99.1%
Colleague Pre P1 7	13,103	0	0%	99.9%
CADD-Solis VIP Ambulatory Infusion Pump	11,656	3,471	0.1%	99.8%
Intermate	8,133	47	0%	99.9%
Reservoir 1 8ml	7,952	0	0.1%	81.1%
Cadd	7,139	9	0.1%	98.9%
Colleague Cx Volumetric Infusion Pump	6,673	0	0%	99.4%
Spectrum Iq Infusion Pump	5,917	0	0.2%	96.6%
Colleague 3 Volumetric Infusion Pump	5,851	0	0.3%	98.4%
Alaris Pc Unit	5,222	0	0.7%	94.4%
Ivenix Infusion System	4,707	4,167	0%	99.4%
Spectrum IQ	4,497	1,719	0.1%	96.6%
Colleague 3cx Volumetric Infusion Pump	3,748	0	0.4%	98.5%
Flo-Gard 6201 Volumetric Infusion Pump	3,614	0	0.3%	97.5%
SIGMA Spectrum Infusion Pump	3,447	1,128	0.2%	98.1%
CADD Solis VIP Pump	3,342	235	0.1%	99.7%
Reservoir 1.8ML MMT-326A	3,113	174	0.4%	63.3%
Medfusion	3,038	0	0.1%	99.1%
Medfusion 4000 Syringe Infusion Pump	2,927	557	0%	99.9%

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	1,346,524	73.5%
Baxter Healthcare	147,536	8.1%
Baxter Healthcare - Singapore	56,978	3.1%
Medtronic Puerto Rico Operations	47,402	2.6%
Smiths Medical Asd	28,873	1.6%
Baxter Healthcare Pte	24,961	1.4%
St Paul	23,349	1.3%
Hospira Costa Rica	14,584	0.8%
Baxter Healthcare - Medina	11,705	0.6%
Carefusion 303	11,414	0.6%
Carefusion	10,758	0.6%
Baxter Healthcare Sg	9,911	0.5%
Icu Medical	9,080	0.5%
Baxter Healthcare - Irvine	8,544	0.5%
Baxter Hlthcare	6,772	0.4%

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

Death0.1%1,757

Injury1.3%24,255

Malfunction98.5%1,802,767

Other0.1%1,334

Not given0.1%996

Who filed

Manufacturer report99.1%1,814,868

Voluntary report0.5%8,937

User facility report0%0

Distributor report0.2%2,866

Not given0.2%4,438

Grey bar: all 26,136,888 MAUDE reports.

Device problems coded

Device problem (FDA code)	Reports	Share
Crackthe device cracked	737,829	40.3%
Corrodedthe device corroded	211,734	11.6%
Device displays incorrect message	169,392	9.3%
Breakthe device broke	155,728	8.5%
Display difficult to read	92,364	5%
Device sensing problem	69,533	3.8%
Failure to read input signal	54,318	3%
Device alarm system	51,891	2.8%
Contamination	38,160	2.1%
Physical resistance/sticking	21,876	1.2%
Excess flow or over-infusion	21,703	1.2%
Battery problema problem with the battery	21,343	1.2%
Display or visual feedback problem	20,389	1.1%
Circuit failure	17,466	1%
Failure to sense	17,081	0.9%
Failure to calibrate	15,974	0.9%
Device operates differently than expectedthe device behaved unexpectedly	15,644	0.9%
Electrical /electronic property probleman electrical or electronic problem	15,198	0.8%
Insufficient flow or under infusion	15,121	0.8%
Insufficient device problem information	14,387	0.8%

Questions about pump, infusion reports

What is product code FRN?

FDA's classification code for "Pump, infusion", 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?

1,831,109 reports through August 2026, 52,891 of them in the latest 12 months.

Which brands appear most often?

Alaris Pump Module (684,494), Alaris System (405,159), 8100 Alaris Pump Module (163,612), Spectrum Infusion Pump (147,353) and 8015 Alaris System Pc Unit (54,161). 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.