Separator, Automated, Blood Cell And Plasma, Therapeutic
Adverse-event figures are drawn from the U.S. Food & Drug Administration (FDA) MAUDE database, refreshed March 2026, see our methodology.
OpenFDA device adverse-event casebook.
FDA MAUDE casebook
openFDA event book Separator LIGHT-BOOK · MAUDE
#427 of 1000 · 2,769 reports · 1993–2026
- BOOK 2,769 reports
- RANK #427 of 1000
- DEATH 106 death-typed
- INJ 624 injury-typed
- MALF 1,471 malfunction
- SPAN 1993–2026
- PEAK 2011: 481
- PHOTO Radioimmunoassay
Nearest event-volume peer: Radioimmunoassay, Thyroid-Stimulating Hormone (2 report gap)
Separator, Automated, Blood Cell And Plasma, Therapeutic sits #427 of 1000 among tracked device types with 2,769 MAUDE reports spanning 1993–2026. Rank counts report volume, not confirmed device fault. Event_type Death / Injury / Malfunction are one code per report — not the same population as patient-outcome rows ( methodology). Read with this device → · Lead manufacturer → · Similar-volume device →
Malfunction reports sit below the device-type norm
Separator carries 53.1% MALFUNCTION-coded reports, 11.7pp below the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.
- DEATH 3.8% corpus 1.5% · above corpus mean (+2.3 pp)
- INJ 22.5% corpus 30.3% · below corpus mean (-7.8 pp)
- MALF 53.1% corpus 64.8% · below corpus mean (-11.7 pp)
Lead product-problem code Adverse Event Without Identified Device or Use Problem is 21% of coded problems · Lead manufacturer TERUMO BCT accounts for 100% of manufacturer-tagged reports · Top event location is 60% of location-tagged rows .
Separator in the event-volume neighbourhood
FDA MAUDE report totals among this device type and nearest nationwide peers
- Catheter And…
Catheter And Tip, Suction
2,781 reports
- Radioimmunoas…
Radioimmunoassay, Thyroid-Stimulating Hormone
2,771 reports
- Separator (this)
Separator, Automated, Blood Cell And Plasma, Therapeutic
2,769 reports
- Prosthesis
Prosthesis, Penile
2,754 reports
- Real Time Nuc…
Real Time Nucleic Acid Amplification System
2,746 reports
- System
System, Endovascular Graft, Arteriovenous (Av) Dialysis Access Circuit Stenosis Treatment
2,731 reports
What this shows Separator, Automated, Blood Cell And Plasma, Therapeutic carries 2,769 MAUDE reports, ranked #427 of 1000.
Event Types
Patient Outcomes
FDA patient-outcome codes (separate from event_type). Percentages use this chart's row total.
Top Product Problems
Yearly Trend
Reports fell to 71 in 2025, down from an average of 147 in the two years before.
Related Entities for Separator, Automated, Blood Cell And Plasma, Therapeutic
Top Manufacturers
Event Locations
Nationwide devices with a comparable volume-and-death footprint
Two openFDA-derived peer sets for Separator: nearest by total report volume and nearest by death-typed count, each floored at ≥100 reports so the neighborhoods stay in the advertised mass.
Similar report volume
Nearest other device types by FDA MAUDE report count (2,769 here).
Similar death-typed counts
Nearest other device types by death-typed report count (106 here), distinct from the volume row.
Read our methodology - how this data is sourced, computed, and verified.
Disclaimer: MAUDE figures for Separator are informational only and are not clinical advice. Report codes do not prove device causation. Consult a qualified clinician before acting on this data.
Every figure on PlainHospital is rendered directly from federal source data, no number is typed in by an editor. Event-type mix on this page is computed from FDA MAUDE codes for Separator; corpus means use device types with ≥100 reports. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of August 2026.