PlainHospital
2026 data FDA MAUDE openFDA FDA Class II

Accessories, Pump, Infusion

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 §880.5725 (General Hospital panel).

Browse devices → Device safety hub

FDA MAUDE casebook

openFDA event book Accessories, Pump, Infusion LIGHT-BOOK · MAUDE

#868 of 1000 · 537 reports · 2004–2026

  • BOOK 537 reports
  • RANK #868 of 1000
  • DEATH 0 death-typed
  • INJ 23 injury-typed
  • MALF 501 malfunction
  • SPAN 2004–2026
  • PEAK 2015: 117
  • PHOTO Bag

Nearest event-volume peer: Bag, Urinary, Ileostomy (2 report gap)

Accessories, Pump, Infusion sits #868 of 1000 among tracked device types with 537 MAUDE reports spanning 2004–2026. 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

Accessories, Pump, Infusion carries 93.3% MALFUNCTION-coded reports, 28.5pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 0.0% corpus 1.5% · below corpus mean (-1.5 pp)
  • INJ 4.3% corpus 30.3% · below corpus mean (-26.0 pp)
  • MALF 93.3% corpus 64.8% · above corpus mean (+28.5 pp)

Lead product-problem code Break is 31% of coded problems · Lead manufacturer SMITHS MEDICAL ASD, INC. accounts for 33% of manufacturer-tagged reports · Top event location I is 51% of location-tagged rows .

Accessories, Pump, Infusion in the event-volume neighbourhood

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

reports

What this shows Accessories, Pump, Infusion carries 537 MAUDE reports, ranked #868 of 1000.

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

Event Types

Malfunction 501 (93.3%)
Injury 23 (4.3%)
13 (2.4%)

Patient Outcomes

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

506 (94.2%)
Other 13 (2.4%)
Hospitalization 8 (1.5%)
Required Intervention 6 (1.1%)
R 2 (0.4%)
L 1 (0.2%)
O 1 (0.2%)

Top Product Problems

Break 140
Wireless Communication Problem 49
Device Alarm System 45
Excess Flow or Over-Infusion 22
Adverse Event Without Identified Device or Use Problem 17
Failure to Infuse 17
Power Problem 17
Fluid/Blood Leak 15
Computer Software Problem 14
Thermal Decomposition of Device 14
Infusion or Flow Problem 13
Patient Device Interaction Problem 13
Insufficient Flow or Under Infusion 12
Mechanical Problem 10
Protective Measures Problem 10
Charging Problem 9
Temperature Problem 8
Battery Problem 7
Device Displays Incorrect Message 7
Device Issue 7

Yearly Trend

04
2004: 1
05
2005: 6
06
2006: 2
11
2011: 2
12
2012: 1
15
2015: 117
16
2016: 55
17
2017: 18
18
2018: 46
19
2019: 36
20
2020: 44
21
2021: 61
22
2022: 39
23
2023: 27
24
2024: 41
25
2025: 37
26
2026: 4

Reports in 2025 (37) held close to the prior two-year average of 34.

Related Entities for Accessories, Pump, Infusion

Top Manufacturers

SMITHS MEDICAL ASD, INC. 77
ST PAUL 59
MEDTRONIC MINIMED 37
ICU MEDICAL COSTA RICA LTD. 26
B. BRAUN MELSUNGEN AG 22
ICU MEDICAL, INC. 15

Event Locations

I 275 (51.2%)
218 (40.6%)
HOSPITAL 33 (6.1%)
NO INFORMATION 11 (2.0%)

Compare SMITHS MEDICAL ASD, INC. vs ST PAUL →

Nationwide devices with a comparable report-volume footprint

Accessories, Pump, Infusion carries zero death-typed MAUDE reports, so the peer set below compares report volume only; both axes are floored at ≥100 reports so the neighborhood stays in the advertised mass.

Similar report volume

Nearest other device types by FDA MAUDE report count (537 here).

Bag, Urinary, Ileostomy 539 Container, Specimen, Sterile 539 Culture Media 534 Insufflator 540

Similar death-typed counts

Nearest other device types by death-typed report count (0 here), distinct from the volume row.

Aberrometer, Ophthalmic 0 Accessories, Arthroscopic 0 Accessories, Cleaning Brushes, For Endoscope 0 Accessories, Implant, Dental, Endosseous 0

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

Disclaimer: MAUDE figures for Accessories, Pump, Infusion 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 Accessories, Pump, Infusion; 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.