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2026 data FDA MAUDE openFDA

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.

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FDA MAUDE casebook

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

#850 of 1000 · 533 reports · 2004–2026

  • BOOK 533 reports
  • RANK #850 of 1000
  • DEATH 0 death-typed
  • INJ 23 injury-typed
  • MALF 497 malfunction
  • SPAN 2004–2026
  • PEAK 2015: 117
  • PHOTO Enzymatic Method

Nearest event-volume peer: Enzymatic Method, Creatinine (0 report gap)

Accessories, Pump, Infusion sits #850 of 1000 among tracked device types with 533 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 →

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 0.0% corpus 1.5% · below corpus mean (-1.5 pp)
  • INJ 4.3% corpus 30.4% · below corpus mean (-26.1 pp)
  • MALF 93.2% corpus 64.5% · above corpus mean (+28.7 pp)

Lead product-problem code Wireless Communication Problem is 14% of coded problems · Lead manufacturer SMITHS MEDICAL ASD, INC. accounts for 34% of manufacturer-tagged reports · Top event location I is 52% 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 533 MAUDE reports, ranked #850 of 1000.

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

Event Types

Malfunction 497 (93.2%)
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

Wireless Communication Problem 46
Device Alarm System 45
Break 34
Excess Flow or Over-Infusion 22
Failure to Infuse 16
Power Problem 16
Fluid/Blood Leak 15
Computer Software Problem 14
Thermal Decomposition of Device 14
Infusion or Flow Problem 13
Patient Device Interaction Problem 13
Adverse Event Without Identified Device or Use Problem 12
Insufficient Flow or Under Infusion 12
Mechanical Problem 10
Protective Measures Problem 10
Charging Problem 9
Battery Problem 7
Electrical /Electronic Property Problem 7
Intermittent Communication Failure 7
Temperature Problem 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: 36
26
2026: 1

Related Entities for Accessories, Pump, Infusion

Top Manufacturers

SMITHS MEDICAL ASD, INC. 80
ST PAUL 59
MEDTRONIC MINIMED 37
ICU MEDICAL COSTA RICA LTD. 26
B. BRAUN MELSUNGEN AG 22
ICU MEDICAL, INC. 12

Event Locations

I 275 (51.6%)
214 (40.2%)
HOSPITAL 33 (6.2%)
NO INFORMATION 11 (2.1%)

Compare SMITHS MEDICAL ASD, INC. vs ST PAUL →

Nationwide devices with similar MAUDE profiles

Two openFDA-derived peer sets for Accessories, Pump, Infusion, 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 (533 here).

Enzymatic Method, Creatinine 533 Culture Media 534 Method, Enzymatic, Glucose 535 Applicator, Absorbent Tipped, Non-Sterile 536

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.