2026 data FDA MAUDE openFDA FDA Class II

Set, I.V. Fluid Transfer

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).

FDA MAUDE casebook

openFDA event book Set, I.V. Fluid Transfer MID-BOOK · MAUDE

#178 of 1000 · 14,331 reports · 1992–2026

  • BOOK 14,331 reports
  • RANK #178 of 1000
  • DEATH 20 death-typed
  • INJ 349 injury-typed
  • MALF 13,798 malfunction
  • SPAN 1992–2026
  • PEAK 2022: 1,834
  • PHOTO Lens

Nearest event-volume peer: Lens, Multifocal Intraocular (33 report gap)

Set, I.V. Fluid Transfer sits #178 of 1000 among tracked device types with 14,331 MAUDE reports spanning 1992–2026. 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 run above the device-type norm

Set, I.V. Fluid Transfer carries 96.3% MALFUNCTION-coded reports, 31.5pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 0.1% corpus 1.5% · below corpus mean (-1.4 pp)
  • INJ 2.4% corpus 30.3% · below corpus mean (-27.9 pp)
  • MALF 96.3% corpus 64.8% · above corpus mean (+31.5 pp)

Lead product-problem code Fluid/Blood Leak is 50% of coded problems · Lead manufacturer BAXTER HEALTHCARE CORPORATION accounts for 67% of manufacturer-tagged reports · Top event location is 55% of location-tagged rows .

Set, I.V. Fluid Transfer in the event-volume neighbourhood

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

reports

What this shows Set, I.V. Fluid Transfer carries 14,331 MAUDE reports, ranked #178 of 1000.

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

Event Types

Malfunction 13,798 (96.3%)
Injury 349 (2.4%)
90 (0.6%)
Other 73 (0.5%)
Death 20 (0.1%)
No answer provided 1 (0.0%)

Patient Outcomes

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

13,550 (94.7%)
Other 473 (3.3%)
Required Intervention 114 (0.8%)
Hospitalization 49 (0.3%)
Life Threatening 34 (0.2%)
R 32 (0.2%)
Death 20 (0.1%)
L 9 (0.1%)
O 9 (0.1%)
Disability 9 (0.1%)
S 3 (0.0%)
Congenital Anomaly 3 (0.0%)
Invalid Data 2 (0.0%)

Top Product Problems

Fluid/Blood Leak 6,564
Device Contamination with Chemical or Other Material 2,900
Leak/Splash 664
Disconnection 409
Device Displays Incorrect Message 267
Infusion or Flow Problem 266
Air/Gas in Device 259
Break 258
Contamination /Decontamination Problem 224
Device Operates Differently Than Expected 212
Material Puncture/Hole 157
Protective Measures Problem 142
Defective Device 140
Overdelivery 119
Fitting Problem 115
No Flow 106
Contamination 102
Defective Component 98
Device Alarm System 98
Nonstandard Device 90

Yearly Trend

92
1992: 3
93
1993: 9
94
1994: 50
95
1995: 10
96
1996: 107
97
1997: 198
98
1998: 42
99
1999: 20
00
2000: 36
01
2001: 19
02
2002: 33
03
2003: 44
04
2004: 48
05
2005: 15
06
2006: 11
07
2007: 18
08
2008: 27
09
2009: 37
10
2010: 49
11
2011: 155
12
2012: 529
13
2013: 154
14
2014: 155
15
2015: 128
16
2016: 219
17
2017: 536
18
2018: 1,499
19
2019: 1,634
20
2020: 1,171
21
2021: 933
22
2022: 1,834
23
2023: 1,047
24
2024: 1,270
25
2025: 1,356
26
2026: 935

Reports in 2025 (1,356) held close to the prior two-year average of 1,159.

Related Entities for Set, I.V. Fluid Transfer

Event Locations

7,844 (54.7%)
I 5,419 (37.8%)
NO INFORMATION 443 (3.1%)
HOSPITAL 413 (2.9%)
OTHER 104 (0.7%)
INVALID DATA 31 (0.2%)
UNKNOWN 30 (0.2%)
OUTPATIENT TREATMENT FACILITY 25 (0.2%)
HOME 21 (0.1%)
NOT APPLICABLE 1 (0.0%)

Compare BAXTER HEALTHCARE CORPORATION vs SMITHS MEDICAL ASD, INC. →

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Set, I.V. Fluid Transfer: 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 (14,331 here).

Similar death-typed counts

Nearest other device types by death-typed report count (20 here), distinct from the volume row.

Disclaimer: MAUDE figures for Set, I.V. Fluid Transfer 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 Set, I.V. Fluid Transfer; 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.