System, dialysate delivery, sealed medical device reports that FDA received
- FDA product code
- FII
- Device class
- Class 2
- Panel
- Gastroenterology, Urology
What a report is
A report is not proof that the device was the cause of the event.
FDA says:
Adverse event reports submitted to FDA do not undergo extensive validation or verification. Therefore, a causal relationship cannot be established between product and reactions listed in a report. While a suspected relationship may exist, it is not medically validated and should not be the sole source of information for clinical decision making or other assumptions about the safety or efficacy of a product. Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product.
Source: openFDA, Device Adverse Event Overview, section "Responsible use of the data". The site read the page on . The data have the reports that FDA received through .
FDA also says:
Although MDRs are a valuable source of information, this passive surveillance system has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data. In addition, the incidence or prevalence of an event cannot be determined from this reporting system alone due to potential under-reporting of events and lack of information about frequency of device use.
Source: openFDA, Device Adverse Event Overview. The site read the page on .
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.
Source: openFDA, Manufacturer and User Facility Device Experience. The site read the page on .
Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated.
Source: openFDA, Response of the drug event API (meta.disclaimer). The site read the page on .
Not medical advice. This site counts what was reported to FDA. Questions about a medicine or device belong with a pharmacist or clinician.
Reports on file
Product code FII is the FDA classification for System, dialysate delivery, sealed. The panel is Gastroenterology, Urology. The device class is 2.
From January 1993 to April 2014, FDA received 3,214 medical device reports that have this product code.
FDA received no report with this product code in the five years to September 2026. The latest report was received in April 2014.
The number of people who use the product is not in the data. A count is not a rate.
Product code
FDA gives each type of device a product code of three letters. A report has the code of its device, so a code has the reports of each brand of one device type.
Device class
Class I, II or III is the regulatory class of FDA for the device type. It is not a rating of a product.
Data version
openFDA MAUDE release of 23 Oct 2026. Reports received through 30 Sep 2026.
Brand names of this type
| Brand name, as written on reports | Reports | Reports, 12 months to September 2026 |
|---|---|---|
| Cobe Centrysystem 3 | 1,052 | 0 |
| Fresenius Dialysis Delivery System | 364 | 0 |
| Prisma Control Unit | 566 | 0 |
| Prismaflex System | 452 | 0 |
The rows are in order of name. One product can have more than one spelling, and each spelling is a row.
FDA says:
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.
Source: openFDA, Manufacturer and User Facility Device Experience. The site read the page on .
Manufacturers named
The table has the 6 manufacturers with 5 or more reports that have this product code. The rows are in order of name. A manufacturer with fewer reports is not in the table.
FDA says:
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.
Source: openFDA, Manufacturer and User Facility Device Experience. The site read the page on .
| Manufacturer, as written on reports | Reports |
|---|---|
| B Braun Medical | 6 |
| Baxter Healthcare | 33 |
| Fresenius Medical Care North America | 115 |
| Fresenius USA | 201 |
| Gambro Healthcare | 1,029 |
| Nxstage Medical | 99 |
Manufacturers, importers and device user facilities are mandatory reporters. The guide on what affects a count gives FDA's words.
Reports by month
FDA releases MAUDE data every month. Reports can arrive months after an event, so the newest months grow in later releases.
Event type and report source
| Event type | Reports | Share | Share as a bar |
|---|---|---|---|
| Death | 149 | 4.6% | |
| Injury | 666 | 20.7% | |
| Malfunction | 1,997 | 62.1% | |
| Other | 362 | 11.3% | |
| Not given | 40 | 1.2% |
| Report source | Reports | Share | Share as a bar |
|---|---|---|---|
| Manufacturer report | 2,441 | 75.9% | |
| Voluntary report | 137 | 4.3% | |
| User facility report | 0 | 0% | |
| Distributor report | 314 | 9.8% | |
| Not given | 322 | 10% |
The event type is the classification that the reporter gave. FDA does not verify it.
Device problems coded
| Device problem (FDA code) | Reports | Share |
|---|---|---|
| Device issuea problem with the device | 325 | 10.1% |
| Replace | 255 | 7.9% |
| Alarm, audible | 253 | 7.9% |
| Device alarm system | 244 | 7.6% |
| Other (for use when an appropriate device code cannot be identified) | 241 | 7.5% |
| Output, high | 170 | 5.3% |
| Leak/splashthe device leaked | 149 | 4.6% |
| Repair | 129 | 4% |
| Air leak | 117 | 3.6% |
| Fluid/blood leak | 106 | 3.3% |
| Device displays incorrect message | 96 | 3% |
| Insufficient flow or under infusion | 77 | 2.4% |
| Normal | 75 | 2.3% |
| Output, low | 73 | 2.3% |
| Bubble(s) | 67 | 2.1% |
| Excess flow or over-infusion | 59 | 1.8% |
| Inadequate ultra filtration | 57 | 1.8% |
| Disconnection | 55 | 1.7% |
| Dislodged | 45 | 1.4% |
| Inaccurate delivery | 44 | 1.4% |
Official pages
- Medical Device Reporting (MDR): How to Report Medical Device ProblemsThe FDA page that tells how to report a problem with a medical device.
- MedWatch Online Voluntary Reporting FormThe online form of FDA for a voluntary report.
- Manufacturer and User Facility Device Experience (MAUDE) DatabaseThe search page of FDA for the device reports.
The site checked these addresses on . The links open in a new tab.
Cite this page
Reported Reactions. System, dialysate delivery, sealed (product code FII): medical device reports that FDA received. https://reportedreactions.com/device-type/fii/ Source: U.S. Food and Drug Administration, openFDA Device Adverse Event (MAUDE) files, release of . Reports received through .
Where the data come from
The counts come from the openFDA Device Adverse Event (MAUDE) bulk files, release of 23 Oct 2026. The files have the reports that FDA received through 30 Sep 2026. Brand names, generic names and manufacturer names are as written on the reports. The names of the product codes come from the device classification of FDA.
The site does not publish a report narrative, a lot number, a detail of a patient or the identity of a reporter. The record of FDA is the authority. See how the site counts reports, the data sources and the corrections page.
Questions
What is product code FII?
It is the FDA classification code for System, dialysate delivery, sealed, class 2, in the Gastroenterology, Urology panel. Each device report has the product code of the device.
What event types do the reports record?
Death (149), injury (666), malfunction (1,997) and other (362). The event type is the classification that the reporter gave. FDA does not verify it.
Can the table of brand names rank the devices?
No. FDA says:
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.
Source: openFDA, Manufacturer and User Facility Device Experience. The site read the page on .
Brands also differ in the number of devices in use and in their time on the market.