Devices › Dialyzer, high permeability with or without sealed dialysate system
Device brand name · Hemodialysis machine
Fresenius: medical device reports filed with FDA
314 reports name it, 1992–2016. Manufacturer given most often on reports: Fresenius USA. Product code KDI.
- 314
- device reports naming the brand
- 0% of all MAUDE reports · about 9 a year
- 0
- reports, 12 months to August 2026
- 0 in the 12 months before
- 13.7%
- classified as malfunction
- 64.6% across the product code
- 6.1%
- classified as death, as reported
- 19 reports · not verified by FDA
FDA's MAUDE database holds 314 reports that name the brand "Fresenius" (hemodialysis machine), received between July 1992 and October 2016; the manufacturer given most often on reports is Fresenius USA. 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 injury (67.2%), malfunction (13.7%) and other (11.5%); 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 leak/splash (15.6%), reaction (11.1%) and high flux rate (7%). The patient problems coded most often are hemodialysis, reaction, systemic and fever. 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 Fresenius was received in the five years to August 2026; the latest was received in October 2016.
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 |
|---|---|---|---|
| Leak/splashthe device leaked | 49 | 15.6% | 3.8% |
| Reactiona reaction, type not specified | 35 | 11.1% | 0.4% |
| High flux rate | 22 | 7% | 0% |
| Device alarm system | 15 | 4.8% | 0.8% |
| Disconnection | 10 | 3.2% | 0.9% |
| Conductivity | 8 | 2.5% | 0% |
| Loss of powerthe device lost power | 8 | 2.5% | 0.2% |
| Difficult to removethe device was hard to remove | 7 | 2.2% | 0.1% |
| Material separation | 7 | 2.2% | 0.1% |
| Display difficult to read | 6 | 1.9% | 0% |
| Inadequate service | 4 | 1.3% | 0% |
| Inadequate ultra filtration | 4 | 1.3% | 1.9% |
| Malfunction | 4 | 1.3% | 0% |
| Other (for use when an appropriate device code cannot be identified) | 4 | 1.3% | 0.3% |
| Replace | 4 | 1.3% | 1.3% |
| Detachment of device component | 3 | 1% | 2.5% |
| Device contamination with body fluid | 3 | 1% | 0.2% |
| Failure to pump | 3 | 1% | 0% |
| Loose or intermittent connection | 3 | 1% | 0.5% |
| Alarm, audible | 2 | 0.6% | 2.8% |
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 |
|---|---|---|
| Hemodialysis | 94 | 29.9% |
| Reaction, systemic | 38 | 12.1% |
| Fever | 27 | 8.6% |
| Pyrogenic | 25 | 8% |
| Hypersensitivity/allergic reaction | 18 | 5.7% |
| Low blood pressure/ hypotension | 14 | 4.5% |
| Bleeding | 13 | 4.1% |
| Therapy/non-surgical treatment, additional | 10 | 3.2% |
| Hemolysis | 9 | 2.9% |
| Hospitalization required | 9 | 2.9% |
| Nauseafeeling sick | 9 | 2.9% |
| Body temperature, elevated | 8 | 2.5% |
| Vomitingbeing sick | 8 | 2.5% |
| Other (for use when an appropriate patient code cannot be identified) | 7 | 2.2% |
| Treatment with medication(s) | 7 | 2.2% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Fresenius | Product code KDI | All MAUDE reports |
|---|---|---|---|
| Reports | 314 | 43,764 | 26,136,888 |
| Share of that pool | — | 0.7% | 0% |
| Classified as death, per 1,000 reports | 61 | 59 | 9 |
| Classified as injury | 67.2% | 27.9% | 36.2% |
| Classified as malfunction | 13.7% | 64.6% | 62.3% |
| Filed by the manufacturer | 1.9% | 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 Fresenius reports
How many FDA reports name Fresenius?
314 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?
injury (67.2%), malfunction (13.7%) and other (11.5%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
leak/splash (15.6%), reaction (11.1%), high flux rate (7%), device alarm system (4.8%) and disconnection (3.2%). These are FDA's device problem codes as entered on the report.
Who files these reports?
distributor reports (40.1%), voluntary reports (13.7%) and manufacturer reports (1.9%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Fresenius 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.