Devices › System, dialysate delivery, sealed
Device brand name · Hemodialysis machine
Fresenius Dialysis Delivery System: medical device reports filed with FDA
364 reports name it, 1997–2013. Manufacturer given most often on reports: Fresenius Medical Care-North America. Product code FII.
- 364
- device reports naming the brand
- 0% of all MAUDE reports · about 12 a year
- 0
- reports, 12 months to August 2026
- 0 in the 12 months before
- 60.4%
- classified as malfunction
- 62.1% across the product code
- 11%
- classified as death, as reported
- 40 reports · not verified by FDA
FDA's MAUDE database holds 364 reports that name the brand "Fresenius Dialysis Delivery System" (hemodialysis machine), received between April 1997 and November 2013; the manufacturer given most often on reports is Fresenius Medical Care-North America. 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 (60.4%), injury (24.2%) and death (11%); across all system, dialysate delivery, sealed reports (product code FII) death is recorded in 4.6% and malfunction in 62.1%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are insufficient flow or under infusion (15.7%), device alarm system (10.4%) and inadequate ultra filtration (8.8%). The patient problems coded most often are low blood pressure/ hypotension, other (for use when an appropriate patient code cannot be identified) and therapy/non-surgical treatment, additional. 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 Dialysis Delivery System was received in the five years to August 2026; the latest was received in November 2013.
By year received
Event type and report source
Event type, as classified on the report
Who filed the report
Grey bar: all 3,214 reports carrying product code FII. 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 |
|---|---|---|---|
| Insufficient flow or under infusion | 57 | 15.7% | 2.4% |
| Device alarm system | 38 | 10.4% | 7.6% |
| Inadequate ultra filtration | 32 | 8.8% | 1.8% |
| Other (for use when an appropriate device code cannot be identified) | 24 | 6.6% | 7.5% |
| Replace | 18 | 4.9% | 7.9% |
| Output, low | 15 | 4.1% | 2.3% |
| Output, high | 14 | 3.8% | 5.3% |
| Fire | 13 | 3.6% | 0.2% |
| Fluid/blood leak | 13 | 3.6% | 3.3% |
| Leak/splashthe device leaked | 13 | 3.6% | 4.6% |
| Air leak | 10 | 2.7% | 3.6% |
| Underdelivery | 10 | 2.7% | 0.6% |
| Excess flow or over-infusion | 9 | 2.5% | 1.8% |
| Disconnection | 7 | 1.9% | 1.7% |
| Increase in pressure | 7 | 1.9% | 0.9% |
| Smoking | 7 | 1.9% | 0.2% |
| Bubble(s) | 6 | 1.6% | 2.1% |
| Alarm, failure of warning | 5 | 1.4% | 0.8% |
| Device operates differently than expectedthe device behaved unexpectedly | 5 | 1.4% | 0.2% |
| Conductivity | 4 | 1.1% | 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 |
|---|---|---|
| Low blood pressure/ hypotension | 107 | 29.4% |
| Other (for use when an appropriate patient code cannot be identified) | 57 | 15.7% |
| Therapy/non-surgical treatment, additional | 57 | 15.7% |
| Treatment with medication(s) | 48 | 13.2% |
| Weight changes | 48 | 13.2% |
| Cramp(s) | 40 | 11% |
| Hospitalization required | 35 | 9.6% |
| Therapy/non-surgical treatment, aborted/stopped | 34 | 9.3% |
| Deaththe patient died; cause not stated by this term | 32 | 8.8% |
| Blood loss | 26 | 7.1% |
| Nauseafeeling sick | 23 | 6.3% |
| Vomitingbeing sick | 18 | 4.9% |
| Dizzinesslight-headedness or unsteadiness | 17 | 4.7% |
| Breathing difficulties | 12 | 3.3% |
| Loss of consciousnesspassing out | 12 | 3.3% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Fresenius Dialysis Delivery System | Product code FII | All MAUDE reports |
|---|---|---|---|
| Reports | 364 | 3,214 | 26,136,888 |
| Share of that pool | — | 11.3% | 0% |
| Classified as death, per 1,000 reports | 110 | 46 | 9 |
| Classified as injury | 24.2% | 20.7% | 36.2% |
| Classified as malfunction | 60.4% | 62.1% | 62.3% |
| Filed by the manufacturer | 99.2% | 75.9% | 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 FII
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Cobe Centrysystem 3 | 1,052 | 0 | 0.8% |
| Prisma Control Unit | 566 | 0 | 6% |
| Phoenix | 581 | 16 | 5.5% |
| Prismaflex System | 452 | 0 | 1.8% |
| NxStage System One | 3,312 | 120 | 5.7% |
| Fresenius | 314 | 0 | 6.1% |
| System 1000 Spds | 450 | 0 | 3.1% |
| 1550 Hemodialysis Machine | 255 | 0 | 10.6% |
| Meridian Hemodialysis Machine | 236 | 0 | 7.6% |
| Prismaflex | 555 | 4 | 7.7% |
| Fresenius 2008k | 1,756 | 0 | 76.8% |
| Fusa F80b Hf/Ps/1 8/H | 182 | 0 | 0% |
| Optiflux 200nre Dialyzer Finished Assy | 386 | 5 | 0.5% |
| B Braun | 270 | 12 | 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 Fresenius Dialysis Delivery System reports
How many FDA reports name Fresenius Dialysis Delivery System?
364 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 (60.4%), injury (24.2%) and death (11%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
insufficient flow or under infusion (15.7%), device alarm system (10.4%), inadequate ultra filtration (8.8%), other (for use when an appropriate device code cannot be identified) (6.6%) and replace (4.9%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (99.2%) and voluntary reports (0.3%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Fresenius Dialysis Delivery System 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.