Devices › Dialysate concentrate for hemodialysis (liquid or powder)
Device brand name · Dry acid concentrate for bicarbonate dialysis
Granuflo: medical device reports filed with FDA
13,859 reports name it, 2012–2016. Manufacturer given most often on reports: Fresenius Medical Care North America. Product code KPO.
- 13,859
- device reports naming the brand
- 0.1% of all MAUDE reports · about 1,008 a year
- 0
- reports, 12 months to August 2026
- 0 in the 12 months before
- 0%
- classified as malfunction
- 5% across the product code
- 82.1%
- classified as death, as reported
- 11,372 reports · not verified by FDA
FDA's MAUDE database holds 13,859 reports that name the brand "Granuflo" (dry acid concentrate for bicarbonate dialysis), received between October 2012 and October 2016; 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 death (82.1%) and injury (17.9%); 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 insufficient device problem information (99.5%), device operates differently than expected (0%) and patient-device incompatibility (0%). The patient problems coded most often are death, cardiac arrest and myocardial infarction. 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 Granuflo 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 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 |
|---|---|---|---|
| Insufficient device problem information | 13,795 | 99.5% | 92.7% |
| Device operates differently than expectedthe device behaved unexpectedly | 5 | 0% | 0.1% |
| Patient-device incompatibilitythe device did not suit the patient | 4 | 0% | 0% |
| Defective devicethe device was defective | 2 | 0% | 0% |
| Improper or incorrect procedure or method | 2 | 0% | 0.1% |
| Nonstandard device | 2 | 0% | 0% |
| Contamination | 1 | 0% | 0.1% |
| Human-device interface problem | 1 | 0% | 0% |
| Labelling, instructions for use or training problem | 1 | 0% | 0% |
| Material discolored | 1 | 0% | 0.1% |
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 |
|---|---|---|
| Deaththe patient died; cause not stated by this term | 11,215 | 80.9% |
| Cardiac arrestthe heart stopped | 2,518 | 18.2% |
| Myocardial infarctionheart attack | 2,099 | 15.1% |
| Cardiopulmonary arrest | 322 | 2.3% |
| Arrhythmia | 293 | 2.1% |
| Sudden cardiac deatha sudden death from the heart | 264 | 1.9% |
| Stroke/cva | 213 | 1.5% |
| Injurya physical injury | 189 | 1.4% |
| Low blood pressure/ hypotension | 36 | 0.3% |
| Seizures | 21 | 0.2% |
| Complaint, ill-defined | 19 | 0.1% |
| Ventricular tachycardiaa fast rhythm from the lower heart chambers | 19 | 0.1% |
| Ventricular fibrillationa chaotic rhythm from the lower heart chambers | 18 | 0.1% |
| Loss of consciousnesspassing out | 17 | 0.1% |
| Respiratory failurethe lungs could not supply enough oxygen | 17 | 0.1% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Granuflo | Product code KPO | All MAUDE reports |
|---|---|---|---|
| Reports | 13,859 | 30,009 | 26,136,888 |
| Share of that pool | — | 46.2% | 0.1% |
| Classified as death, per 1,000 reports | 821 | 769 | 9 |
| Classified as injury | 17.9% | 17.8% | 36.2% |
| Classified as malfunction | 0% | 5% | 62.3% |
| Filed by the manufacturer | 99.9% | 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 |
|---|---|---|---|
| Naturalyte | 13,751 | 0 | 82.2% |
| NxStage System One | 3,312 | 120 | 5.7% |
| Accusol | 237 | 0 | 0% |
| 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 Granuflo reports
How many FDA reports name Granuflo?
13,859 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?
death (82.1%) and injury (17.9%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
insufficient device problem information (99.5%), device operates differently than expected (0%), patient-device incompatibility (0%), defective device (0%) and improper or incorrect procedure or method (0%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (99.9%) and voluntary reports (0.1%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Granuflo 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.