Devices › System, dialysate delivery, single patient
Device brand name · Sps 1550
1550 Hemodialysis Machine: medical device reports filed with FDA
255 reports name it, 1997–2008. Manufacturer given most often on reports: Baxter Healthcare. Product code FKP.
- 255
- 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
- 53.3%
- classified as malfunction
- 56.6% across the product code
- 10.6%
- classified as death, as reported
- 27 reports · not verified by FDA
255 medical device reports received by FDA name the brand "1550 Hemodialysis Machine" (sps 1550); the manufacturer given most often on reports is Baxter Healthcare; received from April 1997 to November 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 (53.3%), injury (25.9%) and death (10.6%); 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 (11%), excess flow or over-infusion (10.6%) and dislodged (6.7%). The patient problems coded most often are therapy/non-surgical treatment, additional, treatment with medication(s) and therapy/non-surgical treatment, aborted/stopped. 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 1550 Hemodialysis Machine was received in the five years to August 2026; the latest was received in November 2008.
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 | 28 | 11% | 11.5% |
| Excess flow or over-infusion | 27 | 10.6% | 3.5% |
| Dislodged | 17 | 6.7% | 1.9% |
| Inadequate ultra filtration | 14 | 5.5% | 4.9% |
| Output, low | 13 | 5.1% | 4% |
| Insufficient flow or under infusion | 12 | 4.7% | 4.5% |
| Other (for use when an appropriate device code cannot be identified) | 11 | 4.3% | 6.2% |
| Output, high | 11 | 4.3% | 6.9% |
| Loss of powerthe device lost power | 10 | 3.9% | 2.9% |
| Needle, separation | 10 | 3.9% | 0% |
| Replace | 10 | 3.9% | 6.4% |
| Detachment of device component | 9 | 3.5% | 1.1% |
| No audible alarm | 7 | 2.7% | 0.9% |
| Device issuea problem with the device | 6 | 2.4% | 2% |
| Air leak | 5 | 2% | 4% |
| Alarm, failure of warning | 5 | 2% | 1.6% |
| Bubble(s) | 5 | 2% | 1.4% |
| Defective devicethe device was defective | 4 | 1.6% | 0.4% |
| Material separation | 4 | 1.6% | 0.6% |
| Repair | 4 | 1.6% | 1.7% |
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, additional | 84 | 32.9% |
| Treatment with medication(s) | 37 | 14.5% |
| Therapy/non-surgical treatment, aborted/stopped | 36 | 14.1% |
| Electrolyte imbalance | 35 | 13.7% |
| Hospitalization required | 35 | 13.7% |
| Other (for use when an appropriate patient code cannot be identified) | 23 | 9% |
| Cramp(s) | 22 | 8.6% |
| Deaththe patient died; cause not stated by this term | 22 | 8.6% |
| Blood pressure, decreased | 15 | 5.9% |
| Loss of consciousnesspassing out | 11 | 4.3% |
| Blood pressure, low | 9 | 3.5% |
| Blood loss | 7 | 2.7% |
| Weight changes | 7 | 2.7% |
| Cardiac arrestthe heart stopped | 6 | 2.4% |
| Chest painchest pain | 6 | 2.4% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | 1550 Hemodialysis Machine | Product code FKP | All MAUDE reports |
|---|---|---|---|
| Reports | 255 | 1,072 | 26,136,888 |
| Share of that pool | — | 23.8% | 0% |
| Classified as death, per 1,000 reports | 106 | 87 | 9 |
| Classified as injury | 25.9% | 27.6% | 36.2% |
| Classified as malfunction | 53.3% | 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 |
|---|---|---|---|
| System 1000 Spds | 450 | 0 | 3.1% |
| 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 1550 Hemodialysis Machine reports
How many FDA reports name 1550 Hemodialysis Machine?
255 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 (53.3%), injury (25.9%) and death (10.6%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
device alarm system (11%), excess flow or over-infusion (10.6%), dislodged (6.7%), inadequate ultra filtration (5.5%) and output, low (5.1%). 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 1550 Hemodialysis Machine 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.