Devices › Hemodialyzer, re-use, high flux
Device brand name · Msf
Polyflux Lr Capillary Dialyzer: medical device reports filed with FDA
970 reports name it, 2006–2008. Manufacturer given most often on reports: Gambro Dialysatoren. Product code MSF.
- 970
- device reports naming the brand
- 0% of all MAUDE reports · about 49 a year
- 0
- reports, 12 months to August 2026
- 0 in the 12 months before
- 99.7%
- classified as malfunction
- 95.5% across the product code
- 0%
- classified as death, as reported
- 0 reports · not verified by FDA
970 medical device reports received by FDA name the brand "Polyflux Lr Capillary Dialyzer" (msf); the manufacturer given most often on reports is Gambro Dialysatoren; received from October 2006 to September 2008. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.
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 (99.7%), injury (0.2%) and other (0.1%); across all hemodialyzer, re-use, high flux reports (product code MSF) death is recorded in 0.2% and malfunction in 95.5%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are fluid/blood leak (88.5%), material rupture (8.8%) and membrane tear(s) (4.1%). The patient problems coded most often are blood loss, bleeding and breathing difficulties. 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 Polyflux Lr Capillary Dialyzer was received in the five years to August 2026; the latest was received in September 2008.
By year received
Event type and report source
Event type, as classified on the report
Who filed the report
Grey bar: all 1,219 reports carrying product code MSF. 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 |
|---|---|---|---|
| Fluid/blood leak | 858 | 88.5% | 86.9% |
| Material rupture | 85 | 8.8% | 7.1% |
| Membrane tear(s) | 40 | 4.1% | 4.3% |
| Component(s), broken | 13 | 1.3% | 1.8% |
| Tears, rips, holes in device, device material | 6 | 0.6% | 0.5% |
| Leak/splashthe device leaked | 4 | 0.4% | 1.7% |
| Breakthe device broke | 2 | 0.2% | 0.4% |
| Alarm, audible | 1 | 0.1% | 0.4% |
| Insufficient device problem information | 1 | 0.1% | 0.1% |
| Membrane leak(s) | 1 | 0.1% | 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) | Reports | Share |
|---|---|---|
| Blood loss | 883 | 91% |
| Bleeding | 9 | 0.9% |
| Breathing difficulties | 1 | 0.1% |
| Hemorrhage/blood loss/bleeding | 1 | 0.1% |
| Itching sensation | 1 | 0.1% |
| Painpain, site not specified | 1 | 0.1% |
| Therapy/non-surgical treatment, additional | 1 | 0.1% |
| Treatment with medication(s) | 1 | 0.1% |
| Vomitingbeing sick | 1 | 0.1% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Polyflux Lr Capillary Dialyzer | Product code MSF | All MAUDE reports |
|---|---|---|---|
| Reports | 970 | 1,219 | 26,136,888 |
| Share of that pool | — | 79.6% | 0% |
| Classified as death, per 1,000 reports | 0 | 2 | 9 |
| Classified as injury | 0.2% | 1.9% | 36.2% |
| Classified as malfunction | 99.7% | 95.5% | 62.3% |
| Filed by the manufacturer | 99.9% | 97.3% | 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 MSF
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Polyflux R Capillary Dialyzer | 177 | 0 | 0% |
| Ca-Hp Dialyzer Ca-Hp 210 | 177 | 0 | 1.1% |
| Polyflux L Capillary Dialyzer | 231 | 0 | 1.3% |
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 Polyflux Lr Capillary Dialyzer reports
How many FDA reports name Polyflux Lr Capillary Dialyzer?
970 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 (99.7%), injury (0.2%) and other (0.1%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
fluid/blood leak (88.5%), material rupture (8.8%), membrane tear(s) (4.1%), component(s), broken (1.3%) and tears, rips, holes in device, device material (0.6%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (99.9%) and distributor reports (0.1%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Polyflux Lr Capillary Dialyzer 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.