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2026 data FDA MAUDE openFDA

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.

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FDA MAUDE casebook

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

#272 of 1000 · 6,535 reports · 1993–2026

  • BOOK 6,535 reports
  • RANK #272 of 1000
  • DEATH 261 death-typed
  • INJ 927 injury-typed
  • MALF 5,045 malfunction
  • SPAN 1993–2026
  • PEAK 2020: 561
  • PHOTO Continuous

Nearest event-volume peer: Continuous, Ventilator, Home Use (11 report gap)

Separator, Automated, Blood Cell, Diagnostic sits #272 of 1000 among tracked device types with 6,535 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 →

Event-type mix vs corpus

Shares of FDA event_type codes on this device type, compared with the mean across 1,000 device types that have ≥100 MAUDE reports. Codes are report labels, not adjudicated causation.

  • DEATH 4.0% corpus 1.5% · above corpus mean (+2.5 pp)
  • INJ 14.2% corpus 30.4% · below corpus mean (-16.3 pp)
  • MALF 77.2% corpus 64.5% · above corpus mean (+12.7 pp)

Lead product-problem code Adverse Event Without Identified Device or Use Problem is 41% 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 6,535 MAUDE reports, ranked #272 of 1000.

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

Event Types

Malfunction 5,045 (77.2%)
Injury 927 (14.2%)
Death 261 (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 5,141 (75.2%)
793 (11.6%)
Required Intervention 220 (3.2%)
R 216 (3.2%)
Death 198 (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 2,487
Insufficient Information 1,029
High Test Results 453
No Apparent Adverse Event 311
High Readings 240
Use of Device Problem 209
Device Operates Differently Than Expected 176
Mechanical Problem 165
Device Slipped 148
Appropriate Term/Code Not Available 108
Improper or Incorrect Procedure or Method 107
Contamination of Device Ingredient or Reagent 106
Thermal Decomposition of Device 89
Device Handling Problem 74
Incorrect, Inadequate or Imprecise Result or Readings 71
Device Displays Incorrect Message 70
Temperature Problem 68
Inadequate User Interface 42
Patient-Device Incompatibility 40
Unintended Movement 39

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: 460
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: 235
26
2026: 33

Related Entities for Separator, Automated, Blood Cell, Diagnostic

Top Manufacturers

TERUMO BCT 5,066
BAXTER HEALTHCARE CORP. 294
BAXTER HEALTHCARE 60
BAXTER HEALTHCARE CORPORATION 40

Event Locations

3,578 (54.8%)
I 2,610 (39.9%)
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 similar MAUDE profiles

Two openFDA-derived peer sets for Separator, Automated, Blood Cell, Diagnostic, both floored at ≥100 reports so the neighborhoods stay in the advertised mass.

Similar report volume

Nearest other device types by FDA MAUDE report count (6,535 here).

Continuous, Ventilator, Home Use 6,546 Transcatheter Septal Occluder 6,503 Tube, Tracheostomy 6,484 Prosthesis 6,593

Similar death-typed counts

Nearest other device types by death-typed report count (261 here), distinct from the volume row.

Prosthesis 259 Laparoscope, General & Plastic Surgery 257 Console 256 Mesh 256

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.