Devices › System, dialysate delivery, sealed
Device brand name · Intensive care hemodialysis
Prisma Control Unit: medical device reports filed with FDA
566 reports name it, 2001–2010. Manufacturer given most often on reports: Gambro Dasco. Product code FII.
- 566
- device reports naming the brand
- 0% of all MAUDE reports · about 23 a year
- 0
- reports, 12 months to August 2026
- 0 in the 12 months before
- 56%
- classified as malfunction
- 62.1% across the product code
- 6%
- classified as death, as reported
- 34 reports · not verified by FDA
566 medical device reports received by FDA name the brand "Prisma Control Unit" (intensive care hemodialysis); the manufacturer given most often on reports is Gambro Dasco; received from October 2001 to July 2010. 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 (56%), other (30.2%) and injury (7.8%); 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 output, high (14.5%), alarm, audible (10.8%) and other (for use when an appropriate device code cannot be identified) (8.7%). The patient problems coded most often are blood loss, therapy/non-surgical treatment, aborted/stopped and other (for use when an appropriate patient code cannot be identified). 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 Prisma Control Unit was received in the five years to August 2026; the latest was received in July 2010.
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 |
|---|---|---|---|
| Output, high | 82 | 14.5% | 5.3% |
| Alarm, audible | 61 | 10.8% | 7.9% |
| Other (for use when an appropriate device code cannot be identified) | 49 | 8.7% | 7.5% |
| Replace | 46 | 8.1% | 7.9% |
| Output, low | 45 | 8% | 2.3% |
| Device issuea problem with the device | 38 | 6.7% | 10.1% |
| Device displays incorrect message | 34 | 6% | 3% |
| Device alarm system | 33 | 5.8% | 7.6% |
| Material rupture | 33 | 5.8% | 0% |
| Normal | 31 | 5.5% | 2.3% |
| Inaccurate delivery | 30 | 5.3% | 1.4% |
| Fluid/blood leak | 23 | 4.1% | 3.3% |
| Coagulation in device or device ingredient | 13 | 2.3% | 0.5% |
| Self-activation or keying | 10 | 1.8% | 0.2% |
| Signal artifact/noise | 10 | 1.8% | 0.3% |
| Repair | 9 | 1.6% | 4% |
| Air leak | 8 | 1.4% | 3.6% |
| Leak/splashthe device leaked | 8 | 1.4% | 4.6% |
| Malfunction | 8 | 1.4% | 1% |
| Disconnection | 7 | 1.2% | 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 |
|---|---|---|
| Blood loss | 54 | 9.5% |
| Therapy/non-surgical treatment, aborted/stopped | 49 | 8.7% |
| Other (for use when an appropriate patient code cannot be identified) | 41 | 7.2% |
| Deaththe patient died; cause not stated by this term | 38 | 6.7% |
| Weight changes | 29 | 5.1% |
| Hemodialysis | 26 | 4.6% |
| Therapy/non-surgical treatment, additional | 14 | 2.5% |
| Cardiac arrestthe heart stopped | 9 | 1.6% |
| Resuscitation | 8 | 1.4% |
| Blood pressure, low | 6 | 1.1% |
| Hospitalization required | 6 | 1.1% |
| No patient involvement | 5 | 0.9% |
| Bleeding | 4 | 0.7% |
| Low blood pressure/ hypotension | 4 | 0.7% |
| Transfusion of blood products | 3 | 0.5% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Prisma Control Unit | Product code FII | All MAUDE reports |
|---|---|---|---|
| Reports | 566 | 3,214 | 26,136,888 |
| Share of that pool | — | 17.6% | 0% |
| Classified as death, per 1,000 reports | 60 | 46 | 9 |
| Classified as injury | 7.8% | 20.7% | 36.2% |
| Classified as malfunction | 56% | 62.1% | 62.3% |
| Filed by the manufacturer | 68.2% | 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% |
| Fresenius Dialysis Delivery System | 364 | 0 | 11% |
| 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 Prisma Control Unit reports
How many FDA reports name Prisma Control Unit?
566 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 (56%), other (30.2%) and injury (7.8%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
output, high (14.5%), alarm, audible (10.8%), other (for use when an appropriate device code cannot be identified) (8.7%), replace (8.1%) and output, low (8%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (68.2%), distributor reports (31.1%) and voluntary reports (0.2%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Prisma Control Unit 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.