Devices › Set, tubing, blood, with and without anti-regurgitation valve
Device brand name · Set tubing blood with and without anti-regurgitation valve
Custom Combi Set: medical device reports filed with FDA
761 reports name it, 2003–2026. Manufacturer given most often on reports: Erika De Reynosa De C V. Product code FJK.
- 761
- device reports naming the brand
- 0% of all MAUDE reports · about 33 a year
- 15
- reports, 12 months to August 2026
- 49 in the 12 months before
- 87.1%
- classified as malfunction
- 75.7% across the product code
- 3.8%
- classified as death, as reported
- 29 reports · not verified by FDA
761 medical device reports received by FDA name the brand "Custom Combi Set" (set tubing blood with and without anti-regurgitation valve); the manufacturer given most often on reports is Erika De Reynosa De C V; received from February 2003 to August 2026. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.
15 reports arrived in the 12 months to August 2026, down 69% from 49 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 (87.1%), injury (8.9%) and death (3.8%); across all set, tubing, blood, with and without anti-regurgitation valve reports (product code FJK) death is recorded in 3.8% and malfunction in 75.7%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are fluid/blood leak (60.6%), material separation (11%) and kinked (9.1%). The patient problems coded most often are hemorrhage/blood loss/bleeding, blood loss and death. 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
Reports by the month FDA received them. FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases.
By year received
Event type and report source
Event type, as classified on the report
Who filed the report
Grey bar: all 8,114 reports carrying product code FJK. 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 |
|---|---|---|---|
| Fluid/blood leak | 461 | 60.6% | 22.5% |
| Material separation | 84 | 11% | 3.6% |
| Kinkedthe tube or line kinked | 69 | 9.1% | 4.2% |
| Disconnection | 33 | 4.3% | 3.2% |
| Replace | 29 | 3.8% | 4.3% |
| Air leak | 24 | 3.2% | 2.2% |
| Detachment of device component | 15 | 2% | 0.7% |
| Loose or intermittent connection | 12 | 1.6% | 1.4% |
| Hole in material | 11 | 1.4% | 0.6% |
| Leak/splashthe device leaked | 9 | 1.2% | 16.4% |
| Misconnection | 9 | 1.2% | 0.1% |
| Obstruction of flow | 8 | 1.1% | 0.9% |
| Device operates differently than expectedthe device behaved unexpectedly | 6 | 0.8% | 0.3% |
| Insufficient device problem information | 6 | 0.8% | 0.9% |
| Other (for use when an appropriate device code cannot be identified) | 6 | 0.8% | 0.8% |
| Crackthe device cracked | 5 | 0.7% | 2.4% |
| Device dislodged or dislocated | 5 | 0.7% | 0.2% |
| Out-of-box failure | 4 | 0.5% | 0.1% |
| Alarm, audible | 3 | 0.4% | 0.6% |
| Breakthe device broke | 3 | 0.4% | 1.1% |
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 |
|---|---|---|
| Hemorrhage/blood loss/bleeding | 103 | 13.5% |
| Blood loss | 96 | 12.6% |
| Deaththe patient died; cause not stated by this term | 26 | 3.4% |
| Therapy/non-surgical treatment, aborted/stopped | 18 | 2.4% |
| Cardiac arrestthe heart stopped | 15 | 2% |
| Low blood pressure/ hypotension | 13 | 1.7% |
| Loss of consciousnesspassing out | 10 | 1.3% |
| Hospitalization required | 8 | 1.1% |
| Cardiopulmonary arrest | 7 | 0.9% |
| Therapy/non-surgical treatment, additional | 7 | 0.9% |
| Treatment with medication(s) | 7 | 0.9% |
| Dyspneashortness of breath | 5 | 0.7% |
| Exsanguination | 4 | 0.5% |
| Nauseafeeling sick | 4 | 0.5% |
| No patient involvement | 4 | 0.5% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Custom Combi Set | Product code FJK | All MAUDE reports |
|---|---|---|---|
| Reports | 761 | 8,114 | 26,136,888 |
| Share of that pool | — | 9.4% | 0% |
| Classified as death, per 1,000 reports | 38 | 38 | 9 |
| Classified as injury | 8.9% | 18.5% | 36.2% |
| Classified as malfunction | 87.1% | 75.7% | 62.3% |
| Filed by the manufacturer | 99.5% | 87.8% | 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 FJK
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Hemodialysis Bloodlines | 2,569 | 1,135 | 0.4% |
| Combiset Bloodline | 774 | 677 | 0% |
| Combi Set | 293 | 0 | 3.4% |
| Medisystems Hemodialysis Blood Tubing Set | 282 | 0 | 5.7% |
| Cartridge | 198 | 0 | 3% |
| Fresenius | 314 | 0 | 6.1% |
| Liberty Cycler Set Single Conn /Ext Dl | 11,729 | 952 | 0.5% |
| Cobe Centrysystem 3 | 1,052 | 0 | 0.8% |
| Dialyzer | 270 | 69 | 2.2% |
| Fusa F80b Hf/Ps/1 8/H | 182 | 0 | 0% |
| Phoenix | 581 | 16 | 5.5% |
| Prismaflex | 555 | 4 | 7.7% |
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 Custom Combi Set reports
How many FDA reports name Custom Combi Set?
761 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 15 in the latest 12 months.
What kinds of events are reported?
malfunction (87.1%), injury (8.9%) and death (3.8%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
fluid/blood leak (60.6%), material separation (11%), kinked (9.1%), disconnection (4.3%) and replace (3.8%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (99.5%) and distributor 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 Custom Combi Set 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.