Device brand name · Infusion pump
Flo-Gard 6201 Volumetric Infusion Pump: medical device reports filed with FDA
3,615 reports name it, 1996–2012. Manufacturer given most often on reports: Baxter Healthcare Sg. Product code FRN.
- 3,615
- device reports naming the brand
- 0% of all MAUDE reports · about 121 a year
- 0
- reports, 12 months to August 2026
- 0 in the 12 months before
- 97.5%
- classified as malfunction
- 98.5% across the product code
- 0.3%
- classified as death, as reported
- 12 reports · not verified by FDA
FDA's MAUDE database holds 3,615 reports that name the brand "Flo-Gard 6201 Volumetric Infusion Pump" (infusion pump), received between September 1996 and June 2012; the manufacturer given most often on reports is Baxter Healthcare Sg. Spellings of one product vary from report to report.
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 (97.5%), injury (1.9%) and death (0.3%); 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 component(s), broken (52%), excess flow or over-infusion (15.4%) and device displays incorrect message (8.1%). The patient problems coded most often are no patient involvement, overmedicated and overdose. 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
No report naming Flo-Gard 6201 Volumetric Infusion Pump was received in the five years to August 2026; the latest was received in June 2012.
By year received
Event type and report source
Event type, as classified on the report
Who filed the report
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 |
|---|---|---|---|
| Component(s), broken | 1,881 | 52% | 0.2% |
| Excess flow or over-infusion | 555 | 15.4% | 1.2% |
| Device displays incorrect message | 293 | 8.1% | 9.3% |
| Device alarm system | 119 | 3.3% | 2.8% |
| False alarm | 102 | 2.8% | 0.7% |
| Inaccurate flow rate | 90 | 2.5% | 0.1% |
| Breakthe device broke | 87 | 2.4% | 8.5% |
| Crackthe device cracked | 80 | 2.2% | 40.3% |
| Insufficient flow or under infusion | 64 | 1.8% | 0.8% |
| Failure to infuse | 61 | 1.7% | 0.4% |
| Occlusion within devicethe device blocked | 42 | 1.2% | 0.6% |
| Air leak | 40 | 1.1% | 0.6% |
| No device output | 40 | 1.1% | 0% |
| Other (for use when an appropriate device code cannot be identified) | 36 | 1% | 0.1% |
| Failure to deliverthe device did not deliver the dose or item | 31 | 0.9% | 0.8% |
| Display or visual feedback problem | 24 | 0.7% | 1.1% |
| Failure to pump | 23 | 0.6% | 0.1% |
| Device issuea problem with the device | 21 | 0.6% | 0.1% |
| Replace | 21 | 0.6% | 0.1% |
| Increased pump speed | 20 | 0.6% | 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 |
|---|---|---|
| No patient involvement | 233 | 6.4% |
| Overmedicated | 185 | 5.1% |
| Overdosea dose above the recommended amount | 117 | 3.2% |
| Therapy/non-surgical treatment, additional | 40 | 1.1% |
| Underdoseless than the intended dose | 39 | 1.1% |
| Treatment with medication(s) | 26 | 0.7% |
| Other (for use when an appropriate patient code cannot be identified) | 25 | 0.7% |
| Therapy/non-surgical treatment, aborted/stopped | 24 | 0.7% |
| Internal organ perforation | 22 | 0.6% |
| Infiltration into tissue | 21 | 0.6% |
| Deaththe patient died; cause not stated by this term | 17 | 0.5% |
| Hospitalization required | 16 | 0.4% |
| Therapy/non-surgical treatment/delayed/prolonged | 9 | 0.2% |
| Swellingswelling | 8 | 0.2% |
| Low blood pressure/ hypotension | 7 | 0.2% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Flo-Gard 6201 Volumetric Infusion Pump | Product code FRN | All MAUDE reports |
|---|---|---|---|
| Reports | 3,615 | 1,831,109 | 26,136,888 |
| Share of that pool | — | 0.2% | 0% |
| Classified as death, per 1,000 reports | 3 | 1 | 9 |
| Classified as injury | 1.9% | 1.3% | 36.2% |
| Classified as malfunction | 97.5% | 98.5% | 62.3% |
| Filed by the manufacturer | 99.9% | 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 Flo-Gard 6201 Volumetric Infusion Pump reports
How many FDA reports name Flo-Gard 6201 Volumetric Infusion Pump?
3,615 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 0 in the latest 12 months.
What kinds of events are reported?
malfunction (97.5%), injury (1.9%) and death (0.3%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
component(s), broken (52%), excess flow or over-infusion (15.4%), device displays incorrect message (8.1%), device alarm system (3.3%) and false alarm (2.8%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (99.9%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Flo-Gard 6201 Volumetric Infusion Pump 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.