Devices › Oxygenator, cardiopulmonary bypass
Device brand name · Oxygenator cardiopulmonary bypass
Hls Set Advanced: medical device reports filed with FDA
215 reports name it, 2021–2023. Manufacturer given most often on reports: Maquet Cardiopulmonary. Product code DTZ.
- 215
- device reports naming the brand
- 0% of all MAUDE reports · about 39 a year
- 0
- reports, 12 months to August 2026
- 0 in the 12 months before
- 84.7%
- classified as malfunction
- 78.2% across the product code
- 12.1%
- classified as death, as reported
- 26 reports · not verified by FDA
215 medical device reports received by FDA name the brand "Hls Set Advanced" (oxygenator cardiopulmonary bypass); the manufacturer given most often on reports is Maquet Cardiopulmonary; received from January 2021 to August 2023. 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 (84.7%), death (12.1%) and injury (3.3%); across all oxygenator, cardiopulmonary bypass reports (product code DTZ) death is recorded in 4.2% and malfunction in 78.2%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are packaging problem (33.5%), device sensing problem (7.4%) and fluid/blood leak (7%). The patient problems coded most often are no patient involvement, cardiac arrest and hemolysis. 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 10,703 reports carrying product code DTZ. 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 |
|---|---|---|---|
| Packaging problem | 72 | 33.5% | 1.3% |
| Device sensing problem | 16 | 7.4% | 0.3% |
| Fluid/blood leak | 15 | 7% | 23.8% |
| Increase in pressure | 12 | 5.6% | 7% |
| Failure to deliverthe device did not deliver the dose or item | 7 | 3.3% | 0.5% |
| No flow | 7 | 3.3% | 0.5% |
| Noise, audible | 6 | 2.8% | 0.7% |
| Pressure problem | 6 | 2.8% | 2.8% |
| Insufficient flow or under infusion | 5 | 2.3% | 0.6% |
| Failure to sense | 4 | 1.9% | 0.1% |
| Improper chemical reaction | 4 | 1.9% | 0.3% |
| Infusion or flow problema problem with flow or infusion | 4 | 1.9% | 2.5% |
| Insufficient device problem information | 4 | 1.9% | 0.7% |
| Leak/splashthe device leaked | 4 | 1.9% | 16.8% |
| Obstruction of flow | 4 | 1.9% | 2.4% |
| Decrease in pressure | 3 | 1.4% | 0.8% |
| Pumping stopped | 3 | 1.4% | 0.2% |
| Component missing | 2 | 0.9% | 0.2% |
| Connection problema connection problem | 2 | 0.9% | 0.7% |
| Crackthe device cracked | 2 | 0.9% | 2.6% |
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 |
|---|---|---|
| No patient involvement | 28 | 13% |
| Cardiac arrestthe heart stopped | 12 | 5.6% |
| Hemolysis | 5 | 2.3% |
| Air embolism | 2 | 0.9% |
| Anemialow red blood cells | 2 | 0.9% |
| Coagulation disorder | 2 | 0.9% |
| Deaththe patient died; cause not stated by this term | 2 | 0.9% |
| Hypovolemia | 2 | 0.9% |
| Ischemia stroke | 2 | 0.9% |
| Respiratory failurethe lungs could not supply enough oxygen | 2 | 0.9% |
| Ischemia | 1 | 0.5% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Hls Set Advanced | Product code DTZ | All MAUDE reports |
|---|---|---|---|
| Reports | 215 | 10,703 | 26,136,888 |
| Share of that pool | — | 2% | 0% |
| Classified as death, per 1,000 reports | 121 | 42 | 9 |
| Classified as injury | 3.3% | 14.5% | 36.2% |
| Classified as malfunction | 84.7% | 78.2% | 62.3% |
| Filed by the manufacturer | 92.1% | 93.3% | 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 DTZ
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Fusion Hollow Fiber Oxygenator | 1,515 | 996 | 0.7% |
| Capiox Fx Oxygenator | 409 | 0 | 1.5% |
| Tubing Set | 336 | 104 | 14% |
| Sterile Fx25rwc W/ Res | 279 | 0 | 2.5% |
| Sterile Fx25rec W/Res | 277 | 0 | 1.4% |
| Affinity Nt Balance | 271 | 150 | 0.4% |
| Oxygenator Cardiopulmonary Bypass | 274 | 0 | 4.7% |
| Capiox FX Advance Hollow Fiber Oxygenator w Integrated AF w Hardshell Res. | 160 | 68 | 6.3% |
| Hlm Tubing Set W/Bioline Coating | 439 | 0 | 7.1% |
| Navilyst Medical | 252 | 0 | 0.4% |
| Cardiovascular Procedure Kit | 553 | 0 | 1.3% |
| Shunt Sensor Sys500 | 712 | 0 | 0.1% |
| AngioDynamics | 174 | 14 | 1.7% |
| Heart Lung Machine | 1,873 | 283 | 3.7% |
| Apex | 876 | 78 | 1.3% |
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 Hls Set Advanced reports
How many FDA reports name Hls Set Advanced?
215 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 (84.7%), death (12.1%) and injury (3.3%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
packaging problem (33.5%), device sensing problem (7.4%), fluid/blood leak (7%), increase in pressure (5.6%) and failure to deliver (3.3%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (92.1%) and distributor reports (7.4%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Hls Set Advanced 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.