Devices › Tubing, pump, cardiopulmonary bypass
Device brand name · Tubing pump cardiopulmonary bypass
Hlm Tubing Set W/Bioline Coating: medical device reports filed with FDA
439 reports name it, 2014–2020. Manufacturer given most often on reports: Maquet Cardiopulmonary. Product code DWE.
- 439
- device reports naming the brand
- 0% of all MAUDE reports · about 37 a year
- 0
- reports, 12 months to August 2026
- 0 in the 12 months before
- 70.6%
- classified as malfunction
- 84.3% across the product code
- 7.1%
- classified as death, as reported
- 31 reports · not verified by FDA
439 medical device reports received by FDA name the brand "Hlm Tubing Set W/Bioline Coating" (tubing pump cardiopulmonary bypass); the manufacturer given most often on reports is Maquet Cardiopulmonary; received from October 2014 to April 2020. 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 (70.6%), injury (22.3%) and death (7.1%); across all tubing, pump, cardiopulmonary bypass reports (product code DWE) death is recorded in 4.3% and malfunction in 84.3%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are fluid/blood leak (20.5%), leak/splash (18.9%) and device operates differently than expected (15.3%). The patient problems coded most often are death, no patient involvement and low oxygen saturation. 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 Hlm Tubing Set W/Bioline Coating was received in the five years to August 2026; the latest was received in April 2020.
By year received
Event type and report source
Event type, as classified on the report
Who filed the report
Grey bar: all 1,865 reports carrying product code DWE. 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 | 90 | 20.5% | 29.2% |
| Leak/splashthe device leaked | 83 | 18.9% | 11% |
| Device operates differently than expectedthe device behaved unexpectedly | 67 | 15.3% | 5.7% |
| Pressure problem | 24 | 5.5% | 1% |
| Improper flow or infusion | 23 | 5.2% | 1.3% |
| Device displays incorrect message | 14 | 3.2% | 1% |
| Filtration problem | 14 | 3.2% | 0.8% |
| Insufficient device problem information | 10 | 2.3% | 0.8% |
| No flow | 9 | 2.1% | 0.9% |
| Air leak | 8 | 1.8% | 1.7% |
| Increase in pressure | 8 | 1.8% | 1.1% |
| Noise, audible | 8 | 1.8% | 1.6% |
| Occlusion within devicethe device blocked | 8 | 1.8% | 1% |
| Failure to prime | 7 | 1.6% | 0.8% |
| Infusion or flow problema problem with flow or infusion | 7 | 1.6% | 0.9% |
| Output problem | 7 | 1.6% | 0.2% |
| Coagulation in device or device ingredient | 6 | 1.4% | 0.3% |
| Failure to deliverthe device did not deliver the dose or item | 5 | 1.1% | 0% |
| Improper or incorrect procedure or method | 5 | 1.1% | 0.6% |
| Crackthe device cracked | 4 | 0.9% | 4.2% |
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 |
|---|---|---|
| Deaththe patient died; cause not stated by this term | 31 | 7.1% |
| No patient involvement | 23 | 5.2% |
| Low oxygen saturation | 11 | 2.5% |
| Blood loss | 10 | 2.3% |
| Hemolysis | 8 | 1.8% |
| Hemorrhage/blood loss/bleeding | 6 | 1.4% |
| Thrombus | 6 | 1.4% |
| Hypoxialow oxygen | 3 | 0.7% |
| Bradycardiaslow heart rate | 2 | 0.5% |
| Complaint, ill-defined | 2 | 0.5% |
| Injurya physical injury | 2 | 0.5% |
| Air embolism | 1 | 0.2% |
| Brain injury | 1 | 0.2% |
| Discomfortdiscomfort | 1 | 0.2% |
| Hypothermia | 1 | 0.2% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Hlm Tubing Set W/Bioline Coating | Product code DWE | All MAUDE reports |
|---|---|---|---|
| Reports | 439 | 1,865 | 26,136,888 |
| Share of that pool | — | 23.5% | 0% |
| Classified as death, per 1,000 reports | 71 | 43 | 9 |
| Classified as injury | 22.3% | 10.1% | 36.2% |
| Classified as malfunction | 70.6% | 84.3% | 62.3% |
| Filed by the manufacturer | 97.3% | 94.4% | 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 DWE
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Custom Tubing Pack | 1,039 | 353 | 1.1% |
| Tubing Set | 336 | 104 | 14% |
| Cardiovascular Procedure Kit | 553 | 0 | 1.3% |
| Oxygenator Cardiopulmonary Bypass | 274 | 0 | 4.7% |
| Asku | 4,752 | 210 | 1.1% |
| Cardiohelp System | 248 | 0 | 3.6% |
| Terumo Cardiovascular Procedure Kit | 150 | 24 | 0.7% |
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 Hlm Tubing Set W/Bioline Coating reports
How many FDA reports name Hlm Tubing Set W/Bioline Coating?
439 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 (70.6%), injury (22.3%) and death (7.1%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
fluid/blood leak (20.5%), leak/splash (18.9%), device operates differently than expected (15.3%), pressure problem (5.5%) and improper flow or infusion (5.2%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (97.3%) and distributor reports (2.7%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Hlm Tubing Set W/Bioline Coating 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.