Device manufacturer, as written on reports

Baxter Healthcare - Singapore: medical device reports filed with FDA

73,289 reports name it as the manufacturer of the device involved, 2008–2019.

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.

73,289
reports naming it as manufacturer: 0.3% of all MAUDE reports; 0
reports, 12 months to August 2026: 0 in the 12 months before; 98.4%
classified as malfunction: 62.3% across all reports; 0.7%
classified as death, as reported: 0.9% across all reports

73,289 medical device reports received by FDA give Baxter Healthcare - Singapore as the manufacturer of the device involved, 0.3% of the MAUDE database, from August 2008 to December 2019. Manufacturer names are as written on the report; subsidiaries and spelling variants may appear as separate names.

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 (98.4%), injury (0.8%) and death (0.7%). Manufacturers are required to report events they learn of, so a large manufacturer with many products in use files many reports. 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 named most often

Brand	Device type	Reports	Latest 12 months	Classified as death
Colleague	Pump, infusion	21,702	0	0%
Colleague Pre P1 7	Pump, infusion	13,017	0	0%
Flogard	Pump, infusion	12,930	0	0%
Homechoice Pro	System, peritoneal, automatic delivery	8,294	0	3.6%
Homechoice	System, peritoneal, automatic delivery	3,868	0	2.4%
HomeChoice Automated PD Set with Cassette	System, peritoneal, automatic delivery	1,431	149	0.5%
Ipump	Pump, infusion	1,322	0	0.1%
Access	Set, administration, intravascular	1,311	0	0%
Infuso R	Pump, infusion	1,286	0	0%
Colleague Cx Volumetric Infusion Pump Single Channel	Pump, infusion	1,275	0	0.1%
Colleague Cxe Volumetricinfusion Pump	Pump, infusion	999	0	0%
Colleague Cx Triple Channel Volumetric Infusion Pump	Pump, infusion	627	0	1.4%
Colleague Single Channel Volumetric Pump Ce French	Pump, infusion	541	0	0%
Colleague Triple Channel Volumetric Infusion Pump	Pump, infusion	289	0	1.7%
6461500 Infusor Pump 1 Label	Pump, infusion	274	0	0%
Flo-Gard 6201 Volumetric Infusion Pump	Pump, infusion	269	0	0.3%
Infusor	Pump, infusion, elastomeric	224	620	0%
Colleague P1 7	Pump, infusion	184	0	0%
Colleague Pre-P1 7	Pump, infusion	167	0	0%
Refurbed Colleague Cx Volumetric Infusion Pump Single Channe	Pump, infusion	166	0	0%
Flo-Gard	Pump, infusion	154	0	0%
Colleague Color Pump Ce Frenchversion Single	Pump, infusion	151	0	0%
Colleague Volumetric Infusor Pump-Single Channel	Pump, infusion	151	0	1.3%
Duo-Vent Clearlink Luer Activated Valve	Set, administration, intravascular	108	0	0%
Clearlink Duo-Vent Secondary Medication Set	Set, administration, intravascular	107	0	0%
Fg 6301 Dual Chnl Vol Inf Pump2m8064 Service	Pump, infusion	83	0	0.8%
Ni	Set, administration, for peritoneal dialysis, disposable	72	1,587	1.8%
Interlink	Set, administration, intravascular	63	49	0%
Homechoice Low Recirculation Volume Apd Set With Cassette	System, peritoneal, automatic delivery	60	2	0.9%
Home Choice Pro	System, peritoneal, automatic delivery	54	0	5.5%

Brands with a page on this site, 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."

Device types

Product code	Device type	Reports	Share
FRN	Pump, infusion	56,978	77.7%
FKX	System, peritoneal, automatic delivery	14,171	19.3%
FPA	Set, administration, intravascular	1,919	2.6%
BRZ	Set, blood transfusion	111	0.2%
KDJ	Set, administration, for peritoneal dialysis, disposable	32	0%
MEA	Pump, infusion, pca	21	0%
MEB	Pump, infusion, elastomeric	3	0%
FMG	Stopcock, i.v. set	2	0%
GBX	Catheter, irrigation	1	0%
KDI	Dialyzer, high permeability with or without sealed dialysate system	1	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

Death0.7%485

Injury0.8%583

Malfunction98.4%72,136

Other0%1

Not given0.1%84

Grey bar: all 26,136,888 MAUDE reports. Event type is the filer's classification and is not verified by FDA.

Questions about Baxter Healthcare - Singapore reports

How many FDA device reports name Baxter Healthcare - Singapore as manufacturer?

73,289 reports through August 2026, 0 of them in the latest 12 months.

Which of its brands appear most often?

Colleague (21,702), Colleague Pre P1 7 (13,017), Flogard (12,930), Homechoice Pro (8,294) and Homechoice (3,868).

Which device types does it report on?

pump, infusion (77.7%), system, peritoneal, automatic delivery (19.3%), set, administration, intravascular (2.6%) and set, blood transfusion (0.2%).

Does a high count say something about the manufacturer?

Not by itself. Manufacturers must file a report for every event they become aware of, so report volume follows the number 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."

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. Manufacturer names are pooled after company suffixes (Inc., LLC, GmbH and similar) are dropped; names that read as a person rather than an organisation are never published. 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.