Devices › System, dialysate delivery, single patient
Device brand name · Hemodialysis machine
System 1000 Spds: medical device reports filed with FDA
450 reports name it, 1997–2006. Manufacturer given most often on reports: Baxter Healthcare. Product code FKP.
- 450
- device reports naming the brand
- 0% of all MAUDE reports · about 15 a year
- 0
- reports, 12 months to August 2026
- 0 in the 12 months before
- 75.1%
- classified as malfunction
- 56.6% across the product code
- 3.1%
- classified as death, as reported
- 14 reports · not verified by FDA
FDA's MAUDE database holds 450 reports that name the brand "System 1000 Spds" (hemodialysis machine), received between January 1997 and December 2006; the manufacturer given most often on reports is Baxter Healthcare. 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 (75.1%), injury (14.2%) and other (7.3%); across all system, dialysate delivery, single patient reports (product code FKP) death is recorded in 8.7% and malfunction in 56.6%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are device alarm system (15.3%), output, high (10%) and self-activation or keying (9.8%). The patient problems coded most often are therapy/non-surgical treatment, aborted/stopped, therapy/non-surgical treatment, additional and hospitalization required. 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 System 1000 Spds was received in the five years to August 2026; the latest was received in December 2006.
By year received
Event type and report source
Event type, as classified on the report
Who filed the report
Grey bar: all 1,072 reports carrying product code FKP. 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 |
|---|---|---|---|
| Device alarm system | 69 | 15.3% | 11.5% |
| Output, high | 45 | 10% | 6.9% |
| Self-activation or keying | 44 | 9.8% | 4.5% |
| Replace | 33 | 7.3% | 6.4% |
| Inadequate ultra filtration | 29 | 6.4% | 4.9% |
| Conductivity | 27 | 6% | 4.1% |
| Other (for use when an appropriate device code cannot be identified) | 25 | 5.6% | 6.2% |
| Air leak | 24 | 5.3% | 4% |
| Microbial contamination of device | 23 | 5.1% | 0.7% |
| Alarm, audible | 19 | 4.2% | 3.4% |
| Output, low | 19 | 4.2% | 4% |
| Leak/splashthe device leaked | 17 | 3.8% | 3.1% |
| Transducer failure | 17 | 3.8% | 2.1% |
| Unintended system motionthe device moved when it should not have | 17 | 3.8% | 1.6% |
| Device contamination with body fluid | 15 | 3.3% | 2% |
| Insufficient flow or under infusion | 15 | 3.3% | 4.5% |
| Contamination | 14 | 3.1% | 1.2% |
| Underdelivery | 14 | 3.1% | 2.5% |
| Inadequate filtration process | 12 | 2.7% | 1.4% |
| Loss of powerthe device lost power | 12 | 2.7% | 2.9% |
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 |
|---|---|---|
| Therapy/non-surgical treatment, aborted/stopped | 59 | 13.1% |
| Therapy/non-surgical treatment, additional | 57 | 12.7% |
| Hospitalization required | 34 | 7.6% |
| Treatment with medication(s) | 29 | 6.4% |
| Blood loss | 28 | 6.2% |
| Other (for use when an appropriate patient code cannot be identified) | 26 | 5.8% |
| Low blood pressure/ hypotension | 25 | 5.6% |
| Weight changes | 18 | 4% |
| Cramp(s) | 15 | 3.3% |
| Blood pressure, decreased | 12 | 2.7% |
| Blood pressure, low | 12 | 2.7% |
| Deaththe patient died; cause not stated by this term | 12 | 2.7% |
| Bacterial infectiona bacterial infection | 10 | 2.2% |
| Loss of consciousnesspassing out | 10 | 2.2% |
| Breathing difficulties | 8 | 1.8% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | System 1000 Spds | Product code FKP | All MAUDE reports |
|---|---|---|---|
| Reports | 450 | 1,072 | 26,136,888 |
| Share of that pool | — | 42% | 0% |
| Classified as death, per 1,000 reports | 31 | 87 | 9 |
| Classified as injury | 14.2% | 27.6% | 36.2% |
| Classified as malfunction | 75.1% | 56.6% | 62.3% |
| Filed by the manufacturer | 100% | 81.9% | 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 FKP
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| 1550 Hemodialysis Machine | 255 | 0 | 10.6% |
| Fresenius | 314 | 0 | 6.1% |
| Phoenix | 581 | 16 | 5.5% |
| Cobe Centrysystem 3 | 1,052 | 0 | 0.8% |
| Fresenius Dialysis Delivery System | 364 | 0 | 11% |
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 System 1000 Spds reports
How many FDA reports name System 1000 Spds?
450 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 (75.1%), injury (14.2%) and other (7.3%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
device alarm system (15.3%), output, high (10%), self-activation or keying (9.8%), replace (7.3%) and inadequate ultra filtration (6.4%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (100%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that System 1000 Spds 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.