Pump, infusion, elastomeric: medical device reports filed with FDA

33,522 reports carry this product code, 1993–2026; 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.

33,522
reports with this product code: 0.1% of all MAUDE reports; 1,385
reports, 12 months to August 2026: 1,397 in the 12 months before; 90.4%
classified as malfunction: 62.3% across all reports; 0.2%
classified as death, as reported: 0.9% across all reports

Product code MEB is FDA's classification for "Pump, infusion, elastomeric" (general Hospital panel), a class 2 device. 33,522 medical device reports carry this product code, 0.1% of the MAUDE database, from November 1993 to August 2026.

1,385 reports arrived in the 12 months to August 2026, close to the 1,397 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 (90.4%), injury (5.9%) and other (3.2%). 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
Infusor	14,804	620	0%	99.5%
FOLFusor	7,404	525	0%	99.5%
Easypump	730	90	0.1%	81.8%
On-Q Painbuster	314	0	0.6%	4.3%
On-Q Pain Pump	259	0	0%	2.3%
On-Q Pump	226	0	0.9%	5.3%
Eclipse Homepump	193	0	0%	97.8%
Ce Infusor Lv 5 12 Pack	192	0	0%	99%
Easypump 2	165	14	0%	100%
Intermate	126	47	0%	99.9%
On-Q Silversoaker	118	0	0.7%	4%
Stryker	70	5	1.3%	46.3%
Ce Intermate Lv 100 24 Pack 50126	59	0	0%	99.4%
Ce Intermate Lv 250 24 Pack 50126	46	0	0%	98.7%
Eclipse	19	44	0.7%	82.2%
Unknown Catheter	14	26	2.2%	38.1%
Avanos	8	38	1.2%	91.2%
Donjoy	6	3	0%	68.9%
Flogard	5	0	0%	99.9%
Infusomat Space	5	12	0.2%	96.1%
Catheter	4	9	3.7%	27.9%
Asku	3	210	1.1%	47.1%
Infuso R Pump	3	0	0%	99.2%
Walkmed	3	0	0%	95.8%
Infusomat Space - Us Version	2	0	0.2%	92.4%
Cadd Ms3 Pump	1	0	0%	93.7%
Clearlink Continu-Flo Solution Set	1	6	0.1%	98.6%
Infusion Pump	1	6	3.7%	46.1%
Novum IQ	1	809	0.2%	91.2%
Synchromed	1	3	3.2%	35.2%

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."

Manufacturers named

Manufacturer (as written on reports)	Reports	Share
Baxter Healthcare - Irvine	14,691	43.8%
Baxter Healthcare	10,017	29.9%
I-Flow	2,442	7.3%
B Braun Melsungen	1,613	4.8%
Avanos Medical	547	1.6%
Stryker Instruments Kalamazoo	221	0.7%
Stryker Instruments	125	0.4%
Stryker	52	0.2%
Halyard Health	33	0.1%
B Braun Medical	29	0.1%
Kimberly-Clark	28	0.1%
Alaris Medical Systems	23	0.1%
Moog Medical Devices Group	20	0.1%
Hospira	4	0%
Baxter Healthcare - Singapore	3	0%

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

Death0.2%59

Injury5.9%1,962

Malfunction90.4%30,314

Other3.2%1,066

Not given0.4%121

Who filed

Manufacturer report94.7%31,743

Voluntary report4.6%1,533

User facility report0%0

Distributor report0%16

Not given0.7%230

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

Device problems coded

Device problem (FDA code)	Reports	Share
Fluid/blood leak	6,560	19.6%
Filling problem	4,794	14.3%
Material rupture	3,748	11.2%
No flow	3,154	9.4%
Excess flow or over-infusion	2,499	7.5%
Device contamination with chemical or other material	1,886	5.6%
Leak/splashthe device leaked	1,576	4.7%
Infusion or flow problema problem with flow or infusion	1,250	3.7%
Insufficient device problem information	1,172	3.5%
Breakthe device broke	979	2.9%
Insufficient flow or under infusion	928	2.8%
Inaccurate flow rate	680	2%
Failure to infuse	637	1.9%
Failure to deliverthe device did not deliver the dose or item	524	1.6%
Detachment of device component	346	1%
Disconnection	315	0.9%
Device operates differently than expectedthe device behaved unexpectedly	298	0.9%
Crackthe device cracked	258	0.8%
Component missing	251	0.7%
Improper flow or infusion	231	0.7%

Questions about pump, infusion, elastomeric reports

What is product code MEB?

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

33,522 reports through August 2026, 1,385 of them in the latest 12 months.

Which brands appear most often?

Infusor (14,804), FOLFusor (7,404), Easypump (730), On-Q Painbuster (314) and On-Q Pain Pump (259). 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.