Devices › Tubing, pump, cardiopulmonary bypass
Device brand name · Tubing pump cardiopulmonary bypass
Custom Tubing Pack: medical device reports filed with FDA
1,039 reports name it, 1997–2026. Manufacturer given most often on reports: Medtronic Mexico. Product code DWE.
- 1,039
- device reports naming the brand
- 0% of all MAUDE reports · about 36 a year
- 353
- reports, 12 months to August 2026
- 196 in the 12 months before
- 95.2%
- classified as malfunction
- 84.3% across the product code
- 1.1%
- classified as death, as reported
- 11 reports · not verified by FDA
1,039 medical device reports received by FDA name the brand "Custom Tubing Pack" (tubing pump cardiopulmonary bypass); the manufacturer given most often on reports is Medtronic Mexico; received from June 1997 to August 2026. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.
353 reports arrived in the 12 months to August 2026, up 80% from 196 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 (95.2%), injury (3.7%) and death (1.1%); 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 (39.4%), delivered as unsterile product (20.8%) and material separation (13.8%). The patient problems coded most often are hemorrhage/blood loss/bleeding, air embolism and no patient involvement. 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 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 | 409 | 39.4% | 29.2% |
| Delivered as unsterile product | 216 | 20.8% | 0.6% |
| Material separation | 143 | 13.8% | 4.2% |
| Obstruction of flow | 73 | 7% | 3.9% |
| Material puncture/hole | 57 | 5.5% | 2.9% |
| Air/gas in device | 56 | 5.4% | 3.1% |
| Crackthe device cracked | 56 | 5.4% | 4.2% |
| Material deformation | 55 | 5.3% | 2% |
| Misassembled during installation | 43 | 4.1% | 1.6% |
| Packaging problem | 35 | 3.4% | 0.6% |
| Breakthe device broke | 23 | 2.2% | 1.3% |
| Leak/splashthe device leaked | 22 | 2.1% | 11% |
| Component missing | 20 | 1.9% | 0.5% |
| Contamination | 12 | 1.2% | 0.3% |
| Manufacturing, packaging or shipping problem | 11 | 1.1% | 0.3% |
| Increase in pressure | 9 | 0.9% | 1.1% |
| Fracturea broken bone | 7 | 0.7% | 0.3% |
| Kinkedthe tube or line kinked | 6 | 0.6% | 0.9% |
| Blocked connection | 5 | 0.5% | 0.2% |
| Improper flow or infusion | 5 | 0.5% | 1.3% |
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 | 124 | 11.9% |
| Air embolism | 7 | 0.7% |
| No patient involvement | 6 | 0.6% |
| Foreign body in patientpart of a device left in the patient | 3 | 0.3% |
| Bacterial infectiona bacterial infection | 2 | 0.2% |
| Blood loss | 2 | 0.2% |
| Anemialow red blood cells | 1 | 0.1% |
| Cardiac arrestthe heart stopped | 1 | 0.1% |
| Congenital defect/deformity | 1 | 0.1% |
| Deaththe patient died; cause not stated by this term | 1 | 0.1% |
| Embolism/embolus | 1 | 0.1% |
| Heart failure/congestive heart failure | 1 | 0.1% |
| Injurya physical injury | 1 | 0.1% |
| Ischemia stroke | 1 | 0.1% |
| Paralysis | 1 | 0.1% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Custom Tubing Pack | Product code DWE | All MAUDE reports |
|---|---|---|---|
| Reports | 1,039 | 1,865 | 26,136,888 |
| Share of that pool | — | 55.7% | 0% |
| Classified as death, per 1,000 reports | 11 | 43 | 9 |
| Classified as injury | 3.7% | 10.1% | 36.2% |
| Classified as malfunction | 95.2% | 84.3% | 62.3% |
| Filed by the manufacturer | 99.8% | 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 |
|---|---|---|---|
| Hlm Tubing Set W/Bioline Coating | 439 | 0 | 7.1% |
| 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 Custom Tubing Pack reports
How many FDA reports name Custom Tubing Pack?
1,039 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 353 in the latest 12 months.
What kinds of events are reported?
malfunction (95.2%), injury (3.7%) and death (1.1%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
fluid/blood leak (39.4%), delivered as unsterile product (20.8%), material separation (13.8%), obstruction of flow (7%) and material puncture/hole (5.5%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (99.8%) and voluntary 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 Tubing Pack 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.