Device brand name · Infusion pump system

Agilia Sp Mc Wifi Gb: medical device reports filed with FDA

196 reports name it, 2022–2026. Manufacturer given most often on reports: Fresenius Vial S. Product code FRN.

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.

196
device reports naming the brand: 0% of all MAUDE reports · about 51 a year; 20
reports, 12 months to August 2026: 26 in the 12 months before; 93.9%
classified as malfunction: 98.5% across the product code; 3.1%
classified as death, as reported: 6 reports · not verified by FDA

FDA's MAUDE database holds 196 reports that name the brand "Agilia Sp Mc Wifi Gb" (infusion pump system), received between September 2022 and July 2026; the manufacturer given most often on reports is Fresenius Vial S. Spellings of one product vary from report to report.

20 reports arrived in the 12 months to August 2026, down 23% from 26 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 (93.9%), death (3.1%) and injury (3.1%); across all pump, infusion reports (product code FRN) death is recorded in 0.1% and malfunction in 98.5%. Event type is the reporter's classification of the report, not a verified outcome.

The device problems coded most often are insufficient flow or under infusion (8.2%), excess flow or over-infusion (5.1%) and inaccurate flow rate (1%). The patient problems coded most often are appropriate clinical signs, symptoms and conditions term/code not available, bradycardia and headache. 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

Death3.1%6

Injury3.1%6

Malfunction93.9%184

Other0%0

Not given0%0

Who filed the report

Manufacturer report50%98

Voluntary report1%2

User facility report0%0

Distributor report49%96

Not given0%0

Grey bar: all 1,831,109 reports carrying product code FRN. 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
Insufficient flow or under infusion	16	8.2%	0.8%
Excess flow or over-infusion	10	5.1%	1.2%
Inaccurate flow rate	2	1%	0.1%
Infusion or flow problema problem with flow or infusion	2	1%	0.3%
Use of incorrect control/treatment settings	2	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.

Patient problems coded

Patient problem (FDA code)	Reports	Share
Appropriate clinical signs, symptoms and conditions term/code not available	2	1%
Bradycardiaslow heart rate	2	1%
Headachehead pain	2	1%
High blood pressure/ hypertension	2	1%
Respiratory arrestbreathing stopped	2	1%

Patient problem codes are present mainly in reports filed since 2019 and are often blank.

In context

Measure	Agilia Sp Mc Wifi Gb	Product code FRN	All MAUDE reports
Reports	196	1,831,109	26,136,888
Share of that pool	—	0%	0%
Classified as death, per 1,000 reports	31	1	9
Classified as injury	3.1%	1.3%	36.2%
Classified as malfunction	93.9%	98.5%	62.3%
Filed by the manufacturer	50%	99.1%	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 FRN

Brand	Reports	Latest 12 months	Classified as death
Alaris Pump Module	684,522	0	0%
Alaris System	422,501	33,692	0%
8100 Alaris Pump Module	163,620	0	0%
Spectrum Infusion Pump	147,363	15	0%
8015 Alaris System Pc Unit	54,162	0	0%
Alaris System Pc Unit	24,066	0	0%
8110 Alaris Syringe Pump	22,434	0	0%
Colleague	21,763	0	0%
Reservoir 3ML MMT-332A	19,914	2,008	0.4%
Reservoir 3ml	16,407	0	0.8%
Flogard	15,668	0	0%
Colleague Volumetric Infusion Pump	13,678	0	0.1%
Colleague Pre P1 7	13,103	0	0%
CADD-Solis VIP Ambulatory Infusion Pump	11,721	3,471	0.1%
Intermate	8,261	47	0%

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 Agilia Sp Mc Wifi Gb reports

How many FDA reports name Agilia Sp Mc Wifi Gb?

196 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 20 in the latest 12 months.

What kinds of events are reported?

malfunction (93.9%), death (3.1%) and injury (3.1%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.

What device problems are coded?

insufficient flow or under infusion (8.2%), excess flow or over-infusion (5.1%), inaccurate flow rate (1%), infusion or flow problem (1%) and use of incorrect control/treatment settings (1%). These are FDA's device problem codes as entered on the report.

Who files these reports?

manufacturer reports (50%), distributor reports (49%) and voluntary reports (1%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.

Do these reports show that Agilia Sp Mc Wifi Gb 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.