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2026 data FDA MAUDE openFDA FDA Class II

Microfilter, Blood Transfusion

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 §880.5440 (General Hospital panel).

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FDA MAUDE casebook

openFDA event book Microfilter, Blood Transfusion LIGHT-BOOK · MAUDE

#545 of 1000 · 1,648 reports · 1993–2026

  • BOOK 1,648 reports
  • RANK #545 of 1000
  • DEATH 7 death-typed
  • INJ 109 injury-typed
  • MALF 1,399 malfunction
  • SPAN 1993–2026
  • PEAK 2019: 334
  • PHOTO Retractor

Nearest event-volume peer: Retractor (2 report gap)

Microfilter, Blood Transfusion sits #545 of 1000 among tracked device types with 1,648 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

Microfilter, Blood Transfusion carries 6.6% INJURY-coded reports, 23.7pp below the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 0.4% corpus 1.5% · below corpus mean (-1.1 pp)
  • INJ 6.6% corpus 30.3% · below corpus mean (-23.7 pp)
  • MALF 84.9% corpus 64.8% · above corpus mean (+20.1 pp)

Lead product-problem code Adverse Event Without Identified Device or Use Problem is 33% of coded problems · Lead manufacturer BAXTER HEALTHCARE CORP. accounts for 100% of manufacturer-tagged reports · Top event location I is 37% of location-tagged rows .

Microfilter, Blood Transfusion in the event-volume neighbourhood

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

reports

What this shows Microfilter, Blood Transfusion carries 1,648 MAUDE reports, ranked #545 of 1000.

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

Event Types

Malfunction 1,399 (84.9%)
Injury 109 (6.6%)
Other 105 (6.4%)
28 (1.7%)
Death 7 (0.4%)

Patient Outcomes

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

Other 1,336 (80.5%)
Required Intervention 155 (9.3%)
114 (6.9%)
R 22 (1.3%)
Life Threatening 18 (1.1%)
Death 7 (0.4%)
Hospitalization 7 (0.4%)
L 1 (0.1%)

Top Product Problems

Adverse Event Without Identified Device or Use Problem 766
Coagulation in Device or Device Ingredient 304
Filtration Problem 233
Defective Component 167
Device Operates Differently Than Expected 151
High Test Results 140
Restricted Flow rate 114
Insufficient Device Problem Information 104
High Readings 76
Contamination of Device Ingredient or Reagent 54
Reaction 49
Unknown (for use when the device problem is not known) 33
Material Discolored 24
Other (for use when an appropriate device code cannot be identified) 24
Therapeutic or Diagnostic Output Failure 21
Device Contamination with Body Fluid 19
Air Leak 18
Fluid/Blood Leak 18
Incorrect Or Inadequate Test Results 17
Leak/Splash 16

Yearly Trend

93
1993: 5
94
1994: 19
95
1995: 3
96
1996: 20
97
1997: 77
98
1998: 50
99
1999: 39
00
2000: 18
01
2001: 9
02
2002: 12
03
2003: 1
04
2004: 10
05
2005: 12
06
2006: 19
07
2007: 5
08
2008: 7
09
2009: 8
10
2010: 3
11
2011: 4
12
2012: 2
13
2013: 104
14
2014: 37
15
2015: 58
16
2016: 97
17
2017: 131
18
2018: 58
19
2019: 334
20
2020: 180
21
2021: 18
22
2022: 110
23
2023: 69
24
2024: 19
25
2025: 62
26
2026: 48

Reports rose to 62 in 2025, up from an average of 44 in the two years before - a recent-year increase, not a lifetime pattern.

Related Entities for Microfilter, Blood Transfusion

Top Manufacturers

BAXTER HEALTHCARE CORP. 11

Event Locations

I 606 (36.8%)
518 (31.4%)
HOSPITAL 443 (26.9%)
OTHER 53 (3.2%)
OUTPATIENT TREATMENT FACILITY 9 (0.5%)
INVALID DATA 7 (0.4%)
NO INFORMATION 4 (0.2%)
BLOOD BANK 3 (0.2%)
HOME 2 (0.1%)
UNKNOWN 2 (0.1%)
LABORATORY 1 (0.1%)

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Microfilter, Blood Transfusion: 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 (1,648 here).

Retractor 1,646 Set, Tubing And Support, Ventilator 1,654 Processor, Tissue, Automated 1,657 Endoscopic Guidewire 1,635

Similar death-typed counts

Nearest other device types by death-typed report count (7 here), distinct from the volume row.

Device, Percutaneous Retrieval 7 Dressing, Wound, Occlusive 7 Instrument 7 Joint, Temporomandibular, Implant 7

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

Disclaimer: MAUDE figures for Microfilter, Blood Transfusion 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 Microfilter, Blood Transfusion; 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.