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2026 data FDA MAUDE openFDA

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 Pump, Infusion HEAVY-BOOK · MAUDE

#3 of 1000 · 1,803,616 reports · 1991–2026

  • BOOK 1,803,616 reports
  • RANK #3 of 1000
  • DEATH 1,709 death-typed
  • INJ 23,875 injury-typed
  • MALF 1,775,851 malfunction
  • SPAN 1991–2026
  • PEAK 2022: 888,020
  • PHOTO Integrated Continuous…

Nearest event-volume peer: Integrated Continuous Glucose Monitoring System, Factory Calibrated (109,693 report gap)

Pump, Infusion sits #3 of 1000 among tracked device types with 1,803,616 MAUDE reports spanning 1991–2026. 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 0.1% corpus 1.5% · below corpus mean (-1.4 pp)
  • INJ 1.3% corpus 30.4% · below corpus mean (-29.1 pp)
  • MALF 98.5% corpus 64.5% · above corpus mean (+34.0 pp)

Lead product-problem code Crack is 47% of coded problems · Lead manufacturer CAREFUSION SD accounts for 80% of manufacturer-tagged reports · Top event location is 86% of location-tagged rows .

Pump, Infusion in the event-volume neighbourhood

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

reports

What this shows Pump, Infusion carries 1,803,616 MAUDE reports, ranked #3 of 1000.

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

Event Types

Malfunction 1,775,851 (98.5%)
Injury 23,875 (1.3%)
Death 1,709 (0.1%)
Other 1,185 (0.1%)
993 (0.1%)
No answer provided 3 (0.0%)

Patient Outcomes

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

1,768,112 (98.0%)
Other 21,341 (1.2%)
Required Intervention 5,488 (0.3%)
Hospitalization 3,752 (0.2%)
Death 1,654 (0.1%)
R 1,468 (0.1%)
Life Threatening 1,290 (0.1%)
O 468 (0.0%)
L 277 (0.0%)
Disability 134 (0.0%)
H 118 (0.0%)
S 85 (0.0%)
Congenital Anomaly 78 (0.0%)
D 45 (0.0%)
Invalid Data 25 (0.0%)
C 1 (0.0%)

Top Product Problems

Crack 735,852
Corroded 210,107
Break 136,987
Display Difficult to Read 92,120
Device Sensing Problem 65,283
Failure to Read Input Signal 54,116
Device Alarm System 41,141
Contamination 36,826
No Apparent Adverse Event 27,329
Physical Resistance/Sticking 21,488
Display or Visual Feedback Problem 19,318
Device Displays Incorrect Message 16,867
Appropriate Term/Code Not Available 16,669
Circuit Failure 16,523
Failure to Calibrate 15,917
Battery Problem 15,712
Electrical /Electronic Property Problem 14,819
Insufficient Information 13,915
No Display/Image 12,470
Excess Flow or Over-Infusion 12,357

Yearly Trend

91
1991: 2
92
1992: 60
93
1993: 67
94
1994: 182
95
1995: 132
96
1996: 514
97
1997: 1,355
98
1998: 1,313
99
1999: 1,403
00
2000: 1,121
01
2001: 1,829
02
2002: 7,472
03
2003: 8,527
04
2004: 2,870
05
2005: 9,479
06
2006: 4,705
07
2007: 1,086
08
2008: 8,261
09
2009: 1,952
10
2010: 6,133
11
2011: 41,367
12
2012: 15,477
13
2013: 40,073
14
2014: 94,180
15
2015: 26,742
16
2016: 16,561
17
2017: 12,060
18
2018: 16,591
19
2019: 15,850
20
2020: 94,186
21
2021: 199,342
22
2022: 888,020
23
2023: 165,838
24
2024: 57,731
25
2025: 53,488
26
2026: 7,647

Related Entities for Pump, Infusion

Top Manufacturers

CAREFUSION SD 1,340,984
BAXTER HEALTHCARE CORPORATION 80,552
BAXTER HEALTHCARE - SINGAPORE 56,977
BAXTER HEALTHCARE CORP 50,239
MEDTRONIC PUERTO RICO OPERATIONS CO. 45,885
SMITHS MEDICAL ASD, INC. 25,028
ST PAUL 23,333
BAXTER HEALTHCARE PTE. LTD. 21,070
HOSPIRA COSTA RICA LTD. 13,917
BAXTER HEALTHCARE CORP. 12,639

Event Locations

1,542,928 (85.5%)
I 241,194 (13.4%)
HOSPITAL 11,129 (0.6%)
NO INFORMATION 5,667 (0.3%)
OTHER 1,143 (0.1%)
HOME 611 (0.0%)
INVALID DATA 304 (0.0%)
OUTPATIENT TREATMENT FACILITY 269 (0.0%)
UNKNOWN 263 (0.0%)
NURSING HOME 34 (0.0%)
NOT APPLICABLE 27 (0.0%)
AMBULATORY SURGICAL FACILITY 23 (0.0%)
OUTPATIENT DIAGNOSTIC FACILITY 18 (0.0%)
LONG-TERM CARE FACILITY 2 (0.0%)
EMERGENCY ROOM 1 (0.0%)
IN TRANSIT TO USER/MEDICAL FACILITY 1 (0.0%)
MOBILE HEALTH UNIT 1 (0.0%)
OUTPATIENT CLINIC/SURGERY 1 (0.0%)

Compare CAREFUSION SD vs BAXTER HEALTHCARE CORPORATION →

Nationwide devices with similar MAUDE profiles

Two openFDA-derived peer sets for 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 (1,803,616 here).

Integrated Continuous Glucose Monitoring Sy… 1,913,309 Alternate Controller Enabled Insulin Infusi… 1,088,188 Pump 886,701 Automated Insulin Dosing Device System 838,920

Similar death-typed counts

Nearest other device types by death-typed report count (1,709 here), distinct from the volume row.

System, Appendage Closure, Left Atrial 1,702 Stent, Coronary 1,758 Pump, Infusion, Implanted, Programmable 1,628 Stimulator 1,806

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

Disclaimer: MAUDE figures for 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 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.