Devices › Dialyzer, capillary, hollow fiber
Device brand name · Hollow fiber dialyzer
Ct Gamma Dialyzer Ct 190g: medical device reports filed with FDA
1,011 reports name it, 1998–2006. Manufacturer given most often on reports: Nissho. Product code FJI.
- 1,011
- device reports naming the brand
- 0% of all MAUDE reports · about 35 a year
- 0
- reports, 12 months to August 2026
- 0 in the 12 months before
- 94.9%
- classified as malfunction
- 55.2% across the product code
- 0.3%
- classified as death, as reported
- 3 reports · not verified by FDA
FDA's MAUDE database holds 1,011 reports that name the brand "Ct Gamma Dialyzer Ct 190g" (hollow fiber dialyzer), received between January 1998 and November 2006; the manufacturer given most often on reports is Nissho. 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 (94.9%), other (3.1%) and injury (1.8%); across all dialyzer, capillary, hollow fiber reports (product code FJI) death is recorded in 1.9% and malfunction in 55.2%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are replace (67%), leak/splash (52.9%) and fluid/blood leak (30.6%). The patient problems coded most often are blood loss, therapy/non-surgical treatment, aborted/stopped and therapy/non-surgical treatment/delayed/prolonged. 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 Ct Gamma Dialyzer Ct 190g was received in the five years to August 2026; the latest was received in November 2006.
By year received
Event type and report source
Event type, as classified on the report
Who filed the report
Grey bar: all 8,433 reports carrying product code FJI. 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 |
|---|---|---|---|
| Replace | 677 | 67% | 15.8% |
| Leak/splashthe device leaked | 535 | 52.9% | 21.2% |
| Fluid/blood leak | 309 | 30.6% | 35.6% |
| Reuse | 204 | 20.2% | 4.2% |
| Device contamination with body fluid | 176 | 17.4% | 3% |
| Alarm, audible | 102 | 10.1% | 2.4% |
| Crackthe device cracked | 56 | 5.5% | 2% |
| Repair | 56 | 5.5% | 1.5% |
| Blood in tubing | 25 | 2.5% | 0.6% |
| Complete blockage | 17 | 1.7% | 0.3% |
| Foreign material | 15 | 1.5% | 0.2% |
| Insufficient flow or under infusion | 13 | 1.3% | 0.2% |
| Reactiona reaction, type not specified | 12 | 1.2% | 5.5% |
| Increase in pressure | 8 | 0.8% | 0.2% |
| Decrease in pressure | 7 | 0.7% | 0.1% |
| Device damaged prior to usethe device was damaged before use | 7 | 0.7% | 0.1% |
| Device displays incorrect message | 7 | 0.7% | 0.5% |
| Occlusion within devicethe device blocked | 6 | 0.6% | 0.4% |
| Device alarm system | 4 | 0.4% | 0.2% |
| Disconnection | 4 | 0.4% | 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 |
|---|---|---|
| Blood loss | 663 | 65.6% |
| Therapy/non-surgical treatment, aborted/stopped | 217 | 21.5% |
| Therapy/non-surgical treatment/delayed/prolonged | 180 | 17.8% |
| Bleeding | 81 | 8% |
| Therapy/non-surgical treatment, additional | 70 | 6.9% |
| Treatment with medication(s) | 47 | 4.6% |
| Nauseafeeling sick | 10 | 1% |
| Abdominal cramps | 9 | 0.9% |
| Hospitalization required | 9 | 0.9% |
| Dizzinesslight-headedness or unsteadiness | 8 | 0.8% |
| Blood pressure, decreased | 5 | 0.5% |
| Other (for use when an appropriate patient code cannot be identified) | 5 | 0.5% |
| Vomitingbeing sick | 5 | 0.5% |
| Chillschills or shivering | 4 | 0.4% |
| Fever | 4 | 0.4% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Ct Gamma Dialyzer Ct 190g | Product code FJI | All MAUDE reports |
|---|---|---|---|
| Reports | 1,011 | 8,433 | 26,136,888 |
| Share of that pool | — | 12% | 0% |
| Classified as death, per 1,000 reports | 3 | 19 | 9 |
| Classified as injury | 1.8% | 37.6% | 36.2% |
| Classified as malfunction | 94.9% | 55.2% | 62.3% |
| Filed by the manufacturer | 100% | 75.4% | 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 FJI
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Optiflux 180nre Dialyzer Finished Assy | 3,373 | 69 | 0.6% |
| Optiflux 160nre Dialyzer Finished Assy | 2,840 | 27 | 0.8% |
| Polyflux | 671 | 116 | 0.3% |
| Unknown Distributed Dialyzer | 362 | 0 | 0% |
| Terumo Taf175 Hf/Cr/1 75/M | 240 | 0 | 0% |
| Psn Dialyzer Psn 210 | 594 | 0 | 0.8% |
| Clirans Taf Hf Dialyzer | 212 | 0 | 0% |
| Ca-Hp Dialyzer Ca-Hp 210 | 177 | 0 | 1.1% |
| Optiflux 200nre Dialyzer Finished Assy | 386 | 5 | 0.5% |
| Terumo | 181 | 0 | 2.8% |
| Fresenius | 314 | 0 | 6.1% |
| Dialyzer | 270 | 69 | 2.2% |
| Baxter | 821 | 3 | 3.8% |
| Optiflux F250nre Dialyzer | 256 | 0 | 0.4% |
| Fusa F80a Hf/Ps/1 8/H | 166 | 0 | 1.2% |
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 Ct Gamma Dialyzer Ct 190g reports
How many FDA reports name Ct Gamma Dialyzer Ct 190g?
1,011 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 (94.9%), other (3.1%) and injury (1.8%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
replace (67%), leak/splash (52.9%), fluid/blood leak (30.6%), reuse (20.2%) and device contamination with body fluid (17.4%). 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 Ct Gamma Dialyzer Ct 190g 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.