Devices › Dialyzer, capillary, hollow fiber
Device brand name · Hollow fiber dialyzer
Ca-Hp Dialyzer Ca-Hp 210: medical device reports filed with FDA
177 reports name it, 1998–2005. Manufacturer given most often on reports: Nissho. Product code FJI.
- 177
- device reports naming the brand
- 0% of all MAUDE reports · about 6 a year
- 0
- reports, 12 months to August 2026
- 0 in the 12 months before
- 85.9%
- classified as malfunction
- 55.2% across the product code
- 1.1%
- classified as death, as reported
- 2 reports · not verified by FDA
FDA's MAUDE database holds 177 reports that name the brand "Ca-Hp Dialyzer Ca-Hp 210" (hollow fiber dialyzer), received between April 1998 and April 2005; 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 (85.9%), other (6.8%) and injury (6.2%); 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 leak/splash (49.2%), replace (47.5%) and fluid/blood leak (23.7%). The patient problems coded most often are blood loss, therapy/non-surgical treatment/delayed/prolonged and therapy/non-surgical treatment, aborted/stopped. 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 Ca-Hp Dialyzer Ca-Hp 210 was received in the five years to August 2026; the latest was received in April 2005.
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 |
|---|---|---|---|
| Leak/splashthe device leaked | 87 | 49.2% | 21.2% |
| Replace | 84 | 47.5% | 15.8% |
| Fluid/blood leak | 42 | 23.7% | 35.6% |
| Device contamination with body fluid | 28 | 15.8% | 3% |
| Reuse | 22 | 12.4% | 4.2% |
| Alarm, audible | 19 | 10.7% | 2.4% |
| Reactiona reaction, type not specified | 12 | 6.8% | 5.5% |
| Blood in tubing | 7 | 4% | 0.6% |
| Crackthe device cracked | 5 | 2.8% | 2% |
| Repair | 4 | 2.3% | 1.5% |
| Coagulation in device or device ingredient | 3 | 1.7% | 0.6% |
| Component(s), broken | 3 | 1.7% | 0.2% |
| Insufficient flow or under infusion | 3 | 1.7% | 0.2% |
| Occlusion within devicethe device blocked | 3 | 1.7% | 0.4% |
| Defective devicethe device was defective | 2 | 1.1% | 0% |
| Other (for use when an appropriate device code cannot be identified) | 2 | 1.1% | 0.8% |
| Partial blockage | 2 | 1.1% | 0.1% |
| Detachment of device component | 1 | 0.6% | 0.4% |
| Device alarm system | 1 | 0.6% | 0.2% |
| Fracturea broken bone | 1 | 0.6% | 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 | 102 | 57.6% |
| Therapy/non-surgical treatment/delayed/prolonged | 46 | 26% |
| Therapy/non-surgical treatment, aborted/stopped | 35 | 19.8% |
| Bleeding | 20 | 11.3% |
| Therapy/non-surgical treatment, additional | 18 | 10.2% |
| Treatment with medication(s) | 11 | 6.2% |
| Hemolysis | 9 | 5.1% |
| Hospitalization required | 7 | 4% |
| Abdominal painstomach or belly pain | 5 | 2.8% |
| Reactiona reaction, type not specified | 5 | 2.8% |
| Breathing difficulties | 4 | 2.3% |
| Chest painchest pain | 4 | 2.3% |
| Itching sensation | 3 | 1.7% |
| Other (for use when an appropriate patient code cannot be identified) | 3 | 1.7% |
| Transfusion of blood products | 3 | 1.7% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Ca-Hp Dialyzer Ca-Hp 210 | Product code FJI | All MAUDE reports |
|---|---|---|---|
| Reports | 177 | 8,433 | 26,136,888 |
| Share of that pool | — | 2.1% | 0% |
| Classified as death, per 1,000 reports | 11 | 19 | 9 |
| Classified as injury | 6.2% | 37.6% | 36.2% |
| Classified as malfunction | 85.9% | 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% |
| Ct Gamma Dialyzer Ct 190g | 1,011 | 0 | 0.3% |
| 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% |
| 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 Ca-Hp Dialyzer Ca-Hp 210 reports
How many FDA reports name Ca-Hp Dialyzer Ca-Hp 210?
177 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 (85.9%), other (6.8%) and injury (6.2%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
leak/splash (49.2%), replace (47.5%), fluid/blood leak (23.7%), device contamination with body fluid (15.8%) and reuse (12.4%). 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 Ca-Hp Dialyzer Ca-Hp 210 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.