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2026 data FDA MAUDE openFDA FDA Class II

Separator, Automated, Blood Cell, Diagnostic

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 Class II (moderate risk, special controls required), regulated under 21 CFR §864.9245 (Hematology panel).

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FDA MAUDE casebook

openFDA event book Separator, Automated, Blood Cell, Diagnostic LIGHT-BOOK · MAUDE

#279 of 1000 · 6,575 reports · 1993–2026

  • BOOK 6,575 reports
  • RANK #279 of 1000
  • DEATH 264 death-typed
  • INJ 931 injury-typed
  • MALF 5,078 malfunction
  • SPAN 1993–2026
  • PEAK 2020: 561
  • PHOTO Tube, Tracheostomy

Nearest event-volume peer: Tube, Tracheostomy (W/Wo Connector) (13 report gap)

Separator, Automated, Blood Cell, Diagnostic sits #279 of 1000 among tracked device types with 6,575 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 →

Injury-coded reports sit below the device-type norm

Separator, Automated, Blood Cell, Diagnostic carries 14.2% INJURY-coded reports, 16.1pp below the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 4.0% corpus 1.5% · above corpus mean (+2.5 pp)
  • INJ 14.2% corpus 30.3% · below corpus mean (-16.1 pp)
  • MALF 77.2% corpus 64.8% · above corpus mean (+12.4 pp)

Lead product-problem code Adverse Event Without Identified Device or Use Problem is 32% of coded problems · Lead manufacturer TERUMO BCT accounts for 93% of manufacturer-tagged reports · Top event location is 55% of location-tagged rows .

Separator, Automated, Blood Cell, Diagnostic in the event-volume neighbourhood

FDA MAUDE report totals among this device type and nearest nationwide peers

reports

What this shows Separator, Automated, Blood Cell, Diagnostic carries 6,575 MAUDE reports, ranked #279 of 1000.

Source FDA MAUDE via openFDA, aggregated by PlainHospital As of August 2026

Event Types

Malfunction 5,078 (77.2%)
Injury 931 (14.2%)
Death 264 (4.0%)
216 (3.3%)
Other 86 (1.3%)

Patient Outcomes

FDA patient-outcome codes (separate from event_type). Percentages use this chart's row total.

Other 5,163 (75.3%)
795 (11.6%)
Required Intervention 219 (3.2%)
R 216 (3.1%)
Death 200 (2.9%)
Hospitalization 152 (2.2%)
O 68 (1.0%)
Life Threatening 21 (0.3%)
H 11 (0.2%)
L 11 (0.2%)
S 2 (0.0%)
Disability 1 (0.0%)

Top Product Problems

Adverse Event Without Identified Device or Use Problem 2,561
High Test Results 1,333
Insufficient Device Problem Information 1,168
Device Operates Differently Than Expected 505
No Apparent Adverse Event 325
High Readings 260
Use of Device Problem 223
Unknown (for use when the device problem is not known) 172
Mechanical Problem 166
Device Slipped 153
Device Displays Incorrect Message 145
Improper or Incorrect Procedure or Method 144
Appropriate Device Problem Term/Code Not Available 135
Disposable 125
Fluid/Blood Leak 110
Contamination of Device Ingredient or Reagent 107
Reaction 91
Thermal Decomposition of Device 90
Incorrect, Inadequate or Imprecise Result or Readings 85
Air Leak 84

Yearly Trend

93
1993: 1
94
1994: 5
95
1995: 2
96
1996: 16
97
1997: 72
98
1998: 111
99
1999: 55
00
2000: 57
01
2001: 40
02
2002: 53
03
2003: 33
04
2004: 47
05
2005: 63
06
2006: 19
07
2007: 8
08
2008: 4
09
2009: 16
10
2010: 11
11
2011: 77
12
2012: 551
13
2013: 458
14
2014: 371
15
2015: 357
16
2016: 440
17
2017: 327
18
2018: 354
19
2019: 434
20
2020: 561
21
2021: 490
22
2022: 445
23
2023: 343
24
2024: 444
25
2025: 233
26
2026: 77

Reports fell to 233 in 2025, down from an average of 394 in the two years before.

Related Entities for Separator, Automated, Blood Cell, Diagnostic

Top Manufacturers

TERUMO BCT 5,099
BAXTER HEALTHCARE CORP. 294
BAXTER HEALTHCARE 60
BAXTER HEALTHCARE CORPORATION 40

Event Locations

3,619 (55.0%)
I 2,609 (39.7%)
OTHER 184 (2.8%)
HOSPITAL 93 (1.4%)
NO INFORMATION 25 (0.4%)
OUTPATIENT TREATMENT FACILITY 16 (0.2%)
INVALID DATA 14 (0.2%)
UNKNOWN 9 (0.1%)
BLOOD BANK 5 (0.1%)
DIALYSIS CENTER 1 (0.0%)

Compare TERUMO BCT vs BAXTER HEALTHCARE CORP. →

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Separator, Automated, Blood Cell, Diagnostic: 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 (6,575 here).

Tube, Tracheostomy 6,588 System, Imaging, Pulsed Echo, Ultrasonic 6,516 Ureteroscope And Accessories, Flexible/Rigid 6,637 Hearing Aid, Bone Conduction, Implanted 6,678

Similar death-typed counts

Nearest other device types by death-typed report count (264 here), distinct from the volume row.

Console 264 Laparoscope, General & Plastic Surgery 262 Prosthesis 262 Agent, Injectable, Embolic 259

Read our methodology - how this data is sourced, computed, and verified.

Disclaimer: MAUDE figures for Separator, Automated, Blood Cell, Diagnostic 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, Automated, Blood Cell, Diagnostic; 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.