PlainHospital
2026 data FDA MAUDE openFDA

Pump, Infusion, Enteral

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.

Browse devices → Device safety hub

FDA MAUDE casebook

openFDA event book Pump, Infusion, Enteral MID-BOOK · MAUDE

#169 of 1000 · 14,791 reports · 1992–2026

  • BOOK 14,791 reports
  • RANK #169 of 1000
  • DEATH 84 death-typed
  • INJ 385 injury-typed
  • MALF 14,134 malfunction
  • SPAN 1992–2026
  • PEAK 2017: 2,620
  • PHOTO Suture

Nearest event-volume peer: Suture, Surgical, Absorbable, Polydioxanone (93 report gap)

Pump, Infusion, Enteral sits #169 of 1000 among tracked device types with 14,791 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 →

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 0.6% corpus 1.5% · below corpus mean (-1.0 pp)
  • INJ 2.6% corpus 30.4% · below corpus mean (-27.8 pp)
  • MALF 95.6% corpus 64.5% · above corpus mean (+31.1 pp)

Lead product-problem code Fluid/Blood Leak is 19% of coded problems · Lead manufacturer COVIDIEN accounts for 65% of manufacturer-tagged reports · Top event location I is 59% of location-tagged rows .

Pump, Infusion, Enteral in the event-volume neighbourhood

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

reports

What this shows Pump, Infusion, Enteral carries 14,791 MAUDE reports, ranked #169 of 1000.

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

Event Types

Malfunction 14,134 (95.6%)
Injury 385 (2.6%)
Other 140 (0.9%)
Death 84 (0.6%)
48 (0.3%)

Patient Outcomes

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

13,860 (93.2%)
Other 476 (3.2%)
Hospitalization 136 (0.9%)
Required Intervention 119 (0.8%)
Death 84 (0.6%)
Disability 78 (0.5%)
R 50 (0.3%)
Life Threatening 22 (0.1%)
L 17 (0.1%)
H 12 (0.1%)
S 7 (0.0%)
O 6 (0.0%)
Invalid Data 3 (0.0%)
D 1 (0.0%)

Top Product Problems

Fluid/Blood Leak 1,843
Protective Measures Problem 1,677
No Audible Alarm 961
No Display/Image 831
Excess Flow or Over-Infusion 740
Loss of Power 637
Failure to Deliver 397
Device Alarm System 345
Insufficient Flow or Under Infusion 340
Air/Gas in Device 254
Leak/Splash 236
Device Operates Differently Than Expected 197
Inaccurate Delivery 192
Inaccurate Flow Rate 186
Failure to Auto Stop 177
Volume Accuracy Problem 177
Thermal Decomposition of Device 174
Infusion or Flow Problem 144
Detachment of Device or Device Component 129
Use of Device Problem 124

Yearly Trend

92
1992: 1
93
1993: 2
94
1994: 26
95
1995: 26
96
1996: 61
97
1997: 114
98
1998: 78
99
1999: 78
00
2000: 56
01
2001: 51
02
2002: 35
03
2003: 36
04
2004: 67
05
2005: 34
06
2006: 54
07
2007: 1,150
08
2008: 858
09
2009: 124
10
2010: 220
11
2011: 274
12
2012: 398
13
2013: 349
14
2014: 116
15
2015: 83
16
2016: 1,248
17
2017: 2,620
18
2018: 1,652
19
2019: 742
20
2020: 1,460
21
2021: 1,218
22
2022: 526
23
2023: 284
24
2024: 319
25
2025: 378
26
2026: 53

Related Entities for Pump, Infusion, Enteral

Top Manufacturers

COVIDIEN 6,820
MOOG MEDICAL DEVICES GROUP 3,132
SMITHS MEDICAL ASD, INC. 265
CARDINAL HEALTH 222

Event Locations

I 8,681 (58.7%)
5,351 (36.2%)
HOSPITAL 393 (2.7%)
HOME 113 (0.8%)
NO INFORMATION 71 (0.5%)
INVALID DATA 69 (0.5%)
NURSING HOME 57 (0.4%)
UNKNOWN 24 (0.2%)
OTHER 21 (0.1%)
OUTPATIENT TREATMENT FACILITY 5 (0.0%)
NOT APPLICABLE 4 (0.0%)
LONG-TERM CARE FACILITY 1 (0.0%)
PUBLIC VENUE 1 (0.0%)

Compare COVIDIEN vs MOOG MEDICAL DEVICES GROUP →

Nationwide devices with similar MAUDE profiles

Two openFDA-derived peer sets for Pump, Infusion, Enteral, 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 (14,791 here).

Suture, Surgical, Absorbable, Polydioxanone 14,884 Dressing, Wound, Occlusive 14,583 Laparoscope, Gynecologic 14,581 Tube Tracheostomy And Tube Cuff 14,497

Similar death-typed counts

Nearest other device types by death-typed report count (84 here), distinct from the volume row.

System, X-Ray, Angiographic 84 Catheter, Septostomy 83 Continuous, Ventilator, Home Use 85 Pulse-Generator, Pacemaker, External 85

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

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