Devices › Dialyzer, high permeability with or without sealed dialysate system
Device brand name · Dialyzer high permeability with or without sealed dialysate system
Revaclear: medical device reports filed with FDA
283 reports name it, 2011–2026. Manufacturer given most often on reports: Baxter Healthcare. Product code KDI.
- 283
- device reports naming the brand
- 0% of all MAUDE reports · about 19 a year
- 19
- reports, 12 months to August 2026
- 39 in the 12 months before
- 72.8%
- classified as malfunction
- 64.6% across the product code
- 1.1%
- classified as death, as reported
- 3 reports · not verified by FDA
283 medical device reports received by FDA name the brand "Revaclear" (dialyzer high permeability with or without sealed dialysate system); the manufacturer given most often on reports is Baxter Healthcare; received from May 2011 to August 2026. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.
19 reports arrived in the 12 months to August 2026, down 51% from 39 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 (72.8%), injury (26.1%) and death (1.1%); across all dialyzer, high permeability with or without sealed dialysate system reports (product code KDI) death is recorded in 5.9% and malfunction in 64.6%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are fluid/blood leak (46.3%), device contamination with chemical or other material (18.7%) and insufficient device problem information (4.6%). The patient problems coded most often are hypersensitivity/allergic reaction, low blood pressure/ hypotension and dyspnea. 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
Who filed the report
Grey bar: all 43,764 reports carrying product code KDI. 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 | 131 | 46.3% | 31.9% |
| Device contamination with chemical or other material | 53 | 18.7% | 1.2% |
| Insufficient device problem information | 13 | 4.6% | 9.5% |
| Leak/splashthe device leaked | 9 | 3.2% | 3.8% |
| Crackthe device cracked | 8 | 2.8% | 2.4% |
| Breakthe device broke | 6 | 2.1% | 2.5% |
| Material rupture | 2 | 0.7% | 0.2% |
| Component missing | 1 | 0.4% | 1.1% |
| Contamination | 1 | 0.4% | 1.3% |
| Fracturea broken bone | 1 | 0.4% | 0.1% |
| Loose or intermittent connection | 1 | 0.4% | 0.5% |
| Material twisted/bent | 1 | 0.4% | 0% |
| Moisture or humidity problem | 1 | 0.4% | 0% |
| No flow | 1 | 0.4% | 0% |
| Packaging problem | 1 | 0.4% | 0.2% |
| Particulates | 1 | 0.4% | 0% |
| Patient device interaction problem | 1 | 0.4% | 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 |
|---|---|---|
| Hypersensitivity/allergic reaction | 36 | 12.7% |
| Low blood pressure/ hypotension | 15 | 5.3% |
| Dyspneashortness of breath | 10 | 3.5% |
| Nauseafeeling sick | 10 | 3.5% |
| Vomitingbeing sick | 10 | 3.5% |
| Appropriate clinical signs, symptoms and conditions term/code not available | 7 | 2.5% |
| Itching sensation | 6 | 2.1% |
| Abdominal painstomach or belly pain | 5 | 1.8% |
| Diaphoresis | 5 | 1.8% |
| Hemolysis | 3 | 1.1% |
| Anxietyanxiety | 2 | 0.7% |
| Blood loss | 2 | 0.7% |
| Dizzinesslight-headedness or unsteadiness | 2 | 0.7% |
| Headachehead pain | 2 | 0.7% |
| Hematuria | 2 | 0.7% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Revaclear | Product code KDI | All MAUDE reports |
|---|---|---|---|
| Reports | 283 | 43,764 | 26,136,888 |
| Share of that pool | — | 0.6% | 0% |
| Classified as death, per 1,000 reports | 11 | 59 | 9 |
| Classified as injury | 26.1% | 27.9% | 36.2% |
| Classified as malfunction | 72.8% | 64.6% | 62.3% |
| Filed by the manufacturer | 95.1% | 94.4% | 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 KDI
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| MiniCap | 13,806 | 409 | 1.1% |
| NxStage System One | 3,312 | 120 | 5.7% |
| Optiflux 180nre Dialyzer Finished Assy | 3,373 | 69 | 0.6% |
| Optiflux 160nre Dialyzer Finished Assy | 2,840 | 27 | 0.8% |
| Fresenius 2008k | 1,756 | 0 | 76.8% |
| Prismaflex Sets (St) | 1,364 | 466 | 0.4% |
| 2008T HEMODIALYSIS SYS., with CDX | 1,136 | 31 | 4.8% |
| 2008k2 Hemodialysis Sys Olc/Diasafe Pls | 927 | 3 | 3.9% |
| Prismaflex Sets (M) | 917 | 287 | 0.1% |
| OPTIFLUX F180NRe HF 12/CS 1.7SA EBEAM | 800 | 286 | 0.1% |
| Prismaflex | 555 | 4 | 7.7% |
| OPTIFLUX F160NRe HF 12/CS 1.5SA EBEAM | 466 | 203 | 0% |
| 2008t Hd Sys Cdx W/Bibag Blue Star | 460 | 51 | 2.6% |
| Prismaflex M150 | 443 | 0 | 0.7% |
| Mini-Cap Disconnect W/Pvp-1solution | 456 | 0 | 3.5% |
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 Revaclear reports
How many FDA reports name Revaclear?
283 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 19 in the latest 12 months.
What kinds of events are reported?
malfunction (72.8%), injury (26.1%) and death (1.1%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
fluid/blood leak (46.3%), device contamination with chemical or other material (18.7%), insufficient device problem information (4.6%), leak/splash (3.2%) and crack (2.8%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (95.1%) and voluntary reports (2.5%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Revaclear 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.