Reported Reactions

Devices › Pump, infusion

Device brand name · Infusion pump

Curlin 6000 CMS Infusion Pump: medical device reports filed with FDA

1,448 reports name it, 2016–2026. Manufacturer given most often on reports: Moog Medical Devices Group. Product code FRN.

1,448
device reports naming the brand
0% of all MAUDE reports · about 139 a year
76
reports, 12 months to August 2026
128 in the 12 months before
99.3%
classified as malfunction
98.5% across the product code
0.5%
classified as death, as reported
7 reports · not verified by FDA

1,448 medical device reports received by FDA name the brand "Curlin 6000 CMS Infusion Pump" (infusion pump); the manufacturer given most often on reports is Moog Medical Devices Group; received from February 2016 to August 2026. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.

76 reports arrived in the 12 months to August 2026, down 41% from 128 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 (99.3%), death (0.5%) and injury (0.2%); 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 excess flow or over-infusion (38.9%), insufficient flow or under infusion (32.9%) and protective measures problem (25.1%). The patient problems coded most often are no patient involvement, death and missed dose. 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

02549Sep 2021: 27Oct 2021: 39Nov 2021: 28Dec 2021: 382022Jan 2022: 49Feb 2022: 29Mar 2022: 44Apr 2022: 24May 2022: 42Jun 2022: 22Jul 2022: 36Aug 2022: 25Sep 2022: 19Oct 2022: 2Nov 2022: 0Dec 2022: 02023Jan 2023: 0Feb 2023: 0Mar 2023: 0Apr 2023: 0May 2023: 0Jun 2023: 0Jul 2023: 0Aug 2023: 0Sep 2023: 0Oct 2023: 0Nov 2023: 0Dec 2023: 02024Jan 2024: 0Feb 2024: 0Mar 2024: 0Apr 2024: 0May 2024: 0Jun 2024: 0Jul 2024: 0Aug 2024: 0Sep 2024: 0Oct 2024: 0Nov 2024: 0Dec 2024: 02025Jan 2025: 0Feb 2025: 5Mar 2025: 20Apr 2025: 38May 2025: 12Jun 2025: 9Jul 2025: 25Aug 2025: 19Sep 2025: 20Oct 2025: 16Nov 2025: 8Dec 2025: 52026Jan 2026: 3Feb 2026: 10Mar 2026: 9Apr 2026: 4May 2026: 0Jun 2026: 0Jul 2026: 0Aug 2026: 1

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

02094182016: 5820162017: 2720172018: 13720182019: 9220192020: 22020202021: 41820212022: 29220222025: 17720252026: 272026

Event type and report source

Event type, as classified on the report

Death0.5%7
Injury0.2%3
Malfunction99.3%1,438
Other0%0
Not given0%0

Who filed the report

Manufacturer report99.8%1,445
Voluntary report0%0
User facility report0%0
Distributor report0%0
Not given0.2%3

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)ReportsShareShare across product code
Excess flow or over-infusion56338.9%1.2%
Insufficient flow or under infusion47632.9%0.8%
Protective measures problem36425.1%0.5%
Free or unrestricted flow130.9%0.1%
Failure to deliverthe device did not deliver the dose or item90.6%0.8%
Device operational issue40.3%0%
Infusion or flow problema problem with flow or infusion30.2%0.3%
Insufficient device problem information30.2%0.8%
Material deformation20.1%0%
Mechanical problema mechanical problem20.1%0.3%
Telemetry discrepancy20.1%0%
Battery problema problem with the battery10.1%1.2%
Computer software problema software problem10.1%0.6%
Device operates differently than expectedthe device behaved unexpectedly10.1%0.9%
Failure to infuse10.1%0.4%
Failure to run on battery10.1%0%
False alarm10.1%0.7%
Leak/splashthe device leaked10.1%0.3%
Noise, audible10.1%0%
Volume accuracy problem10.1%0.1%

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)ReportsShare
No patient involvement1449.9%
Deaththe patient died; cause not stated by this term70.5%
Missed dose30.2%
Overdosea dose above the recommended amount30.2%
Ventricular tachycardiaa fast rhythm from the lower heart chambers10.1%

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

In context

MeasureCurlin 6000 CMS Infusion PumpProduct code FRNAll MAUDE reports
Reports1,4481,831,10926,136,888
Share of that pool—0.1%0%
Classified as death, per 1,000 reports519
Classified as injury0.2%1.3%36.2%
Classified as malfunction99.3%98.5%62.3%
Filed by the manufacturer99.8%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

BrandReportsLatest 12 monthsClassified as death
Alaris Pump Module684,52200%
Alaris System422,50133,6920%
8100 Alaris Pump Module163,62000%
Spectrum Infusion Pump147,363150%
8015 Alaris System Pc Unit54,16200%
Alaris System Pc Unit24,06600%
8110 Alaris Syringe Pump22,43400%
Colleague21,76300%
Reservoir 3ML MMT-332A19,9142,0080.4%
Reservoir 3ml16,40700.8%
Flogard15,66800%
Colleague Volumetric Infusion Pump13,67800.1%
Colleague Pre P1 713,10300%
CADD-Solis VIP Ambulatory Infusion Pump11,7213,4710.1%
Intermate8,261470%

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 Curlin 6000 CMS Infusion Pump reports

How many FDA reports name Curlin 6000 CMS Infusion Pump?

1,448 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 76 in the latest 12 months.

What kinds of events are reported?

malfunction (99.3%), death (0.5%) and injury (0.2%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.

What device problems are coded?

excess flow or over-infusion (38.9%), insufficient flow or under infusion (32.9%), protective measures problem (25.1%), free or unrestricted flow (0.9%) and failure to deliver (0.6%). These are FDA's device problem codes as entered on the report.

Who files these reports?

manufacturer reports (99.8%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.

Do these reports show that Curlin 6000 CMS 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.