Devices › Dialysate concentrate for hemodialysis (liquid or powder)
Device brand name · Dialysate concentrate for hemodialysis liquid or powder
Accusol: medical device reports filed with FDA
237 reports name it, 2011–2015. Manufacturer given most often on reports: Baxter Healthcare - Castlebar. Product code KPO.
- 237
- 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
- 99.6%
- classified as malfunction
- 5% across the product code
- 0%
- classified as death, as reported
- 0 reports · not verified by FDA
FDA's MAUDE database holds 237 reports that name the brand "Accusol" (dialysate concentrate for hemodialysis liquid or powder), received between March 2011 and April 2015; the manufacturer given most often on reports is Baxter Healthcare - Castlebar. 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 (99.6%); across all dialysate concentrate for hemodialysis (liquid or powder) reports (product code KPO) death is recorded in 76.9% and malfunction in 5%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are precipitate in device or device ingredient (43.9%), fluid/blood leak (13.1%) and break (9.7%). The patient problems coded most often are no patient involvement, blood loss and body temperature, elevated. 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 Accusol was received in the five years to August 2026; the latest was received in April 2015.
By year received
Event type and report source
Event type, as classified on the report
Who filed the report
Grey bar: all 30,009 reports carrying product code KPO. 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 |
|---|---|---|---|
| Precipitate in device or device ingredient | 104 | 43.9% | 0.5% |
| Fluid/blood leak | 31 | 13.1% | 0.8% |
| Breakthe device broke | 23 | 9.7% | 1% |
| Detachment of device component | 20 | 8.4% | 0.1% |
| Leak/splashthe device leaked | 19 | 8% | 0.9% |
| Device operates differently than expectedthe device behaved unexpectedly | 11 | 4.6% | 0.1% |
| Loose or intermittent connection | 8 | 3.4% | 0% |
| Component falling | 7 | 3% | 0% |
| Device contamination with chemical or other material | 6 | 2.5% | 0.1% |
| Air leak | 5 | 2.1% | 0% |
| Device damaged prior to usethe device was damaged before use | 4 | 1.7% | 0% |
| Hole in material | 4 | 1.7% | 0% |
| Inappropriate waveform | 4 | 1.7% | 0% |
| Sediment, precipitate or deposit in device or device ingredient | 4 | 1.7% | 0% |
| Defective devicethe device was defective | 3 | 1.3% | 0% |
| Material discolored | 3 | 1.3% | 0.1% |
| Particulates | 3 | 1.3% | 0% |
| Bent | 2 | 0.8% | 0% |
| Burst container or vessel | 2 | 0.8% | 0% |
| Disconnection | 2 | 0.8% | 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 |
|---|---|---|
| No patient involvement | 73 | 30.8% |
| Blood loss | 2 | 0.8% |
| Body temperature, elevated | 1 | 0.4% |
| Deaththe patient died; cause not stated by this term | 1 | 0.4% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Accusol | Product code KPO | All MAUDE reports |
|---|---|---|---|
| Reports | 237 | 30,009 | 26,136,888 |
| Share of that pool | — | 0.8% | 0% |
| Classified as death, per 1,000 reports | 0 | 769 | 9 |
| Classified as injury | 0% | 17.8% | 36.2% |
| Classified as malfunction | 99.6% | 5% | 62.3% |
| Filed by the manufacturer | 100% | 98.9% | 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 KPO
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Granuflo | 13,859 | 0 | 82.1% |
| Naturalyte | 13,751 | 0 | 82.2% |
| NxStage System One | 3,312 | 120 | 5.7% |
| Fresenius 2008k | 1,756 | 0 | 76.8% |
| B Braun | 270 | 12 | 3% |
| Fresenius | 314 | 0 | 6.1% |
| Dialyzer | 270 | 69 | 2.2% |
| Tandem T Slim Insulin Delivery System | 55,207 | 0 | 0.1% |
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 Accusol reports
How many FDA reports name Accusol?
237 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 (99.6%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
precipitate in device or device ingredient (43.9%), fluid/blood leak (13.1%), break (9.7%), detachment of device component (8.4%) and leak/splash (8%). 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 Accusol 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.