Devices › Separator, automated, blood cell, diagnostic
Device brand name · Cobe spectra autopbsc set
Cobe Spectra Blood Collection: medical device reports filed with FDA
288 reports name it, 2012–2020. Manufacturer given most often on reports: Terumo Bct. Product code GKT.
- 288
- device reports naming the brand
- 0% of all MAUDE reports · about 20 a year
- 0
- reports, 12 months to August 2026
- 0 in the 12 months before
- 18.8%
- classified as malfunction
- 77.2% across the product code
- 4.2%
- classified as death, as reported
- 12 reports · not verified by FDA
FDA's MAUDE database holds 288 reports that name the brand "Cobe Spectra Blood Collection" (cobe spectra autopbsc set), received between June 2012 and June 2020; the manufacturer given most often on reports is Terumo Bct. Spellings of one product vary from report to report.
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 injury (49.7%), malfunction (18.8%) and death (4.2%); across all separator, automated, blood cell, diagnostic reports (product code GKT) death is recorded in 4% and malfunction in 77.2%. 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 (14.9%), device operates differently than expected (8.7%) and fluid/blood leak (6.9%). The patient problems coded most often are reaction, numbness and tingling. 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 Cobe Spectra Blood Collection was received in the five years to August 2026; the latest was received in June 2020.
By year received
Event type and report source
Event type, as classified on the report
Who filed the report
Grey bar: all 6,581 reports carrying product code GKT. 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 | 43 | 14.9% | 17.8% |
| Device operates differently than expectedthe device behaved unexpectedly | 25 | 8.7% | 7.7% |
| Fluid/blood leak | 20 | 6.9% | 1.6% |
| Patient-device incompatibilitythe device did not suit the patient | 20 | 6.9% | 1% |
| Improper or incorrect procedure or method | 13 | 4.5% | 2.2% |
| Device displays incorrect message | 12 | 4.2% | 2.2% |
| Leak/splashthe device leaked | 12 | 4.2% | 1% |
| Air leak | 9 | 3.1% | 1.3% |
| Detachment of device component | 4 | 1.4% | 0.1% |
| Inadequate user interface | 4 | 1.4% | 0.6% |
| Microbial contamination of device | 4 | 1.4% | 0.8% |
| Device expiration issue | 3 | 1% | 0.1% |
| Device operational issue | 2 | 0.7% | 0.2% |
| Device slipped | 2 | 0.7% | 2.3% |
| Display or visual feedback problem | 2 | 0.7% | 0.1% |
| False positive result | 2 | 0.7% | 0% |
| Inaccurate delivery | 2 | 0.7% | 0% |
| Overfill | 2 | 0.7% | 0.2% |
| Backflow | 1 | 0.3% | 0.1% |
| Breakthe device broke | 1 | 0.3% | 0.1% |
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 | 88 | 30.6% |
| Numbnessnumbness | 62 | 21.5% |
| Tingling | 25 | 8.7% |
| Low blood pressure/ hypotension | 23 | 8% |
| Nauseafeeling sick | 22 | 7.6% |
| Fever | 21 | 7.3% |
| Deaththe patient died; cause not stated by this term | 17 | 5.9% |
| Headachehead pain | 15 | 5.2% |
| Chillschills or shivering | 12 | 4.2% |
| Vomitingbeing sick | 12 | 4.2% |
| Shaking/tremors | 11 | 3.8% |
| Hypersensitivity/allergic reaction | 10 | 3.5% |
| Toxicity | 9 | 3.1% |
| Test result | 8 | 2.8% |
| Cardiac arrestthe heart stopped | 6 | 2.1% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Cobe Spectra Blood Collection | Product code GKT | All MAUDE reports |
|---|---|---|---|
| Reports | 288 | 6,581 | 26,136,888 |
| Share of that pool | — | 4.4% | 0% |
| Classified as death, per 1,000 reports | 42 | 40 | 9 |
| Classified as injury | 49.7% | 14.1% | 36.2% |
| Classified as malfunction | 18.8% | 77.2% | 62.3% |
| Filed by the manufacturer | 100% | 97.4% | 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 GKT
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Trima Accel | 4,241 | 89 | 0.2% |
| Spectra Optia | 2,037 | 70 | 4.9% |
| Pcs2 Plasma Collection System | 264 | 0 | 28.8% |
| Trima Accel Enhanced Plt Pls Rbc Set | 167 | 0 | 0% |
| Baxter | 821 | 3 | 3.8% |
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 Cobe Spectra Blood Collection reports
How many FDA reports name Cobe Spectra Blood Collection?
288 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?
injury (49.7%), malfunction (18.8%) and death (4.2%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
insufficient device problem information (14.9%), device operates differently than expected (8.7%), fluid/blood leak (6.9%), patient-device incompatibility (6.9%) and improper or incorrect procedure or method (4.5%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (100%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Cobe Spectra Blood Collection 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.