Devices › Normothermic machine perfusion system for the preservation of donor livers prior to transplantation
Device brand name · Normothermic machine perfusion system for the preservation of donor livers prior
OrganOx Metra: medical device reports filed with FDA
499 reports name it, 2024–2026. Manufacturer given most often on reports: Organox. Product code QQK.
- 499
- device reports naming the brand
- 0% of all MAUDE reports · about 214 a year
- 277
- reports, 12 months to August 2026
- 139 in the 12 months before
- 74.5%
- classified as malfunction
- 75.5% across the product code
- 0.4%
- classified as death, as reported
- 2 reports · not verified by FDA
FDA's MAUDE database holds 499 reports that name the brand "OrganOx Metra" (normothermic machine perfusion system for the preservation of donor livers prior), received between March 2024 and August 2026; the manufacturer given most often on reports is Organox. Spellings of one product vary from report to report.
277 reports arrived in the 12 months to August 2026, up 99% from 139 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 (74.5%), injury (24.6%) and death (0.4%); across all normothermic machine perfusion system for the preservation of donor livers prior to transplantation reports (product code QQK) death is recorded in 0.4% and malfunction in 75.5%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are physical resistance/sticking (12.8%), restricted flow rate (9.2%) and no flow (8%). The patient problems coded most often are liver damage/dysfunction, low blood pressure/ hypotension and cholangitis. 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 518 reports carrying product code QQK. 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 |
|---|---|---|---|
| Physical resistance/sticking | 64 | 12.8% | 12.4% |
| Restricted flow rate | 46 | 9.2% | 8.9% |
| No flow | 40 | 8% | 7.7% |
| Insufficient flow or under infusion | 39 | 7.8% | 7.5% |
| Insufficient device problem information | 21 | 4.2% | 4.1% |
| Loose or intermittent connection | 18 | 3.6% | 3.5% |
| Premature discharge of battery | 16 | 3.2% | 3.1% |
| Incorrect measurementthe device measured wrongly | 15 | 3% | 2.9% |
| Failure to pump | 14 | 2.8% | 2.9% |
| Material twisted/bent | 14 | 2.8% | 2.7% |
| Inaccurate flow rate | 13 | 2.6% | 2.5% |
| Pressure problem | 13 | 2.6% | 2.5% |
| Pumping problem | 12 | 2.4% | 2.7% |
| Fluid/blood leak | 11 | 2.2% | 2.3% |
| Pumping stopped | 11 | 2.2% | 2.1% |
| Failure to charge | 10 | 2% | 1.9% |
| Charging problem | 9 | 1.8% | 1.7% |
| Complete blockage | 9 | 1.8% | 1.7% |
| Air/gas in device | 8 | 1.6% | 1.5% |
| High readingsreadings were too high | 8 | 1.6% | 1.5% |
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 |
|---|---|---|
| Liver damage/dysfunction | 103 | 20.6% |
| Low blood pressure/ hypotension | 12 | 2.4% |
| Cholangitis | 4 | 0.8% |
| Cramp(s) /muscle spasm(s) | 3 | 0.6% |
| Discomfortdiscomfort | 3 | 0.6% |
| Thrombosis/thrombus | 3 | 0.6% |
| Appropriate clinical signs, symptoms and conditions term/code not available | 2 | 0.4% |
| Graft failure | 2 | 0.4% |
| Back painback pain | 1 | 0.2% |
| Biliary leak | 1 | 0.2% |
| Cardiac arrestthe heart stopped | 1 | 0.2% |
| Embolism/embolus | 1 | 0.2% |
| Hemorrhage/blood loss/bleeding | 1 | 0.2% |
| Necrosisdeath of tissue | 1 | 0.2% |
| Sepsisa severe body-wide response to infection | 1 | 0.2% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | OrganOx Metra | Product code QQK | All MAUDE reports |
|---|---|---|---|
| Reports | 499 | 518 | 26,136,888 |
| Share of that pool | — | 96.3% | 0% |
| Classified as death, per 1,000 reports | 4 | 4 | 9 |
| Classified as injury | 24.6% | 23.7% | 36.2% |
| Classified as malfunction | 74.5% | 75.5% | 62.3% |
| Filed by the manufacturer | 93% | 92.7% | 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."
Questions about OrganOx Metra reports
How many FDA reports name OrganOx Metra?
499 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 277 in the latest 12 months.
What kinds of events are reported?
malfunction (74.5%), injury (24.6%) and death (0.4%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
physical resistance/sticking (12.8%), restricted flow rate (9.2%), no flow (8%), insufficient flow or under infusion (7.8%) and insufficient device problem information (4.2%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (93%), distributor reports (4.6%) and voluntary reports (1.8%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that OrganOx Metra 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.