Devices › Separator, automated, blood cell and plasma, therapeutic
Device brand name · Spectra optia exchange set
Spectra Optia: medical device reports filed with FDA
2,037 reports name it, 2012–2026. Manufacturer given most often on reports: Terumo Bct. Product code LKN.
- 2,037
- device reports naming the brand
- 0% of all MAUDE reports · about 146 a year
- 70
- reports, 12 months to August 2026
- 80 in the 12 months before
- 56.3%
- classified as malfunction
- 53.1% across the product code
- 4.9%
- classified as death, as reported
- 99 reports · not verified by FDA
FDA's MAUDE database holds 2,037 reports that name the brand "Spectra Optia" (spectra optia exchange set), received between July 2012 and August 2026; the manufacturer given most often on reports is Terumo Bct. Spellings of one product vary from report to report.
70 reports arrived in the 12 months to August 2026, down 12% from 80 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 (56.3%), injury (32.3%) and death (4.9%); across all separator, automated, blood cell and plasma, therapeutic reports (product code LKN) death is recorded in 3.8% and malfunction in 53.1%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are insufficient device problem information (25.4%), device displays incorrect message (9.4%) and inadequate user interface (8.8%). The patient problems coded most often are reaction, low blood pressure/ hypotension 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 2,776 reports carrying product code LKN. 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 |
|---|---|---|---|
| Insufficient device problem information | 517 | 25.4% | 20.9% |
| Device displays incorrect message | 191 | 9.4% | 7.8% |
| Inadequate user interface | 179 | 8.8% | 5.8% |
| Improper or incorrect procedure or method | 138 | 6.8% | 6.2% |
| Data problem | 130 | 6.4% | 4.7% |
| Patient data problem | 104 | 5.1% | 3.7% |
| Fluid/blood leak | 73 | 3.6% | 4.8% |
| Device operates differently than expectedthe device behaved unexpectedly | 60 | 2.9% | 5.6% |
| Patient-device incompatibilitythe device did not suit the patient | 55 | 2.7% | 2.7% |
| Excess flow or over-infusion | 52 | 2.6% | 2.2% |
| Nonstandard device | 46 | 2.3% | 1.8% |
| Air leak | 39 | 1.9% | 3.3% |
| Incorrect software programming calculations | 38 | 1.9% | 1.4% |
| Leak/splashthe device leaked | 27 | 1.3% | 1.8% |
| Output problem | 22 | 1.1% | 0.2% |
| Defective component | 18 | 0.9% | 0.4% |
| Obstruction of flow | 18 | 0.9% | 0.4% |
| Occlusion within devicethe device blocked | 18 | 0.9% | 0.8% |
| Coagulation in device or device ingredient | 17 | 0.8% | 0.2% |
| Device operational issue | 17 | 0.8% | 0.6% |
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 |
|---|---|---|
| Reactiona reaction, type not specified | 169 | 8.3% |
| Low blood pressure/ hypotension | 119 | 5.8% |
| Hemolysis | 85 | 4.2% |
| Deaththe patient died; cause not stated by this term | 76 | 3.7% |
| Hypersensitivity/allergic reaction | 74 | 3.6% |
| Hypervolemia | 58 | 2.8% |
| Itching sensation | 49 | 2.4% |
| No patient involvement | 41 | 2% |
| Appropriate clinical signs, symptoms and conditions term/code not available | 38 | 1.9% |
| Rashskin rash | 36 | 1.8% |
| Tachycardiafast heart rate | 36 | 1.8% |
| Dyspneashortness of breath | 35 | 1.7% |
| Fever | 35 | 1.7% |
| Blood loss | 32 | 1.6% |
| Nauseafeeling sick | 29 | 1.4% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Spectra Optia | Product code LKN | All MAUDE reports |
|---|---|---|---|
| Reports | 2,037 | 2,776 | 26,136,888 |
| Share of that pool | — | 73.4% | 0% |
| Classified as death, per 1,000 reports | 49 | 38 | 9 |
| Classified as injury | 32.3% | 22.6% | 36.2% |
| Classified as malfunction | 56.3% | 53.1% | 62.3% |
| Filed by the manufacturer | 98.2% | 95.5% | 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 LKN
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Trima Accel Enhanced Plt Pls Rbc Set | 167 | 0 | 0% |
| Teruflex Blood Bag System | 368 | 0 | 0% |
| Cobe Spectra Blood Collection | 288 | 0 | 4.2% |
| Trima Accel | 4,241 | 89 | 0.2% |
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 Spectra Optia reports
How many FDA reports name Spectra Optia?
2,037 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 70 in the latest 12 months.
What kinds of events are reported?
malfunction (56.3%), injury (32.3%) and death (4.9%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
insufficient device problem information (25.4%), device displays incorrect message (9.4%), inadequate user interface (8.8%), improper or incorrect procedure or method (6.8%) and data problem (6.4%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (98.2%) and voluntary reports (0.2%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Spectra Optia 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.