2026 data FDA MAUDE openFDA

Pump, Infusion, Elastomeric

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 MAUDE casebook

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

#98 of 1000 · 32,825 reports · 1993–2026

  • BOOK 32,825 reports
  • RANK #98 of 1000
  • DEATH 58 death-typed
  • INJ 1,948 injury-typed
  • MALF 29,634 malfunction
  • SPAN 1993–2026
  • PEAK 2015: 2,980
  • PHOTO Wire, Guide, Catheter

Nearest event-volume peer: Wire, Guide, Catheter (2 report gap)

Pump, Infusion, Elastomeric sits #98 of 1000 among tracked device types with 32,825 MAUDE reports spanning 1993–2026. 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 0.2% corpus 1.5% · below corpus mean (-1.3 pp)
  • INJ 5.9% corpus 30.4% · below corpus mean (-24.5 pp)
  • MALF 90.3% corpus 64.5% · above corpus mean (+25.8 pp)

Lead product-problem code Fluid/Blood Leak is 25% of coded problems · Lead manufacturer BAXTER HEALTHCARE - IRVINE accounts for 56% of manufacturer-tagged reports · Top event location is 62% of location-tagged rows .

Pump, Infusion, Elastomeric in the event-volume neighbourhood

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

reports

What this shows Pump, Infusion, Elastomeric carries 32,825 MAUDE reports, ranked #98 of 1000.

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

Event Types

Malfunction 29,634 (90.3%)
Injury 1,948 (5.9%)
Other 1,064 (3.2%)
121 (0.4%)
Death 58 (0.2%)

Patient Outcomes

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

29,368 (89.1%)
Other 2,042 (6.2%)
Required Intervention 933 (2.8%)
Hospitalization 206 (0.6%)
R 120 (0.4%)
Disability 111 (0.3%)
Death 63 (0.2%)
O 48 (0.1%)
Life Threatening 30 (0.1%)
S 29 (0.1%)
L 15 (0.0%)
H 7 (0.0%)
Congenital Anomaly 2 (0.0%)

Top Product Problems

Fluid/Blood Leak 4,193
Filling Problem 3,992
No Flow 1,888
Material Rupture 1,704
Excess Flow or Over-Infusion 1,055
Infusion or Flow Problem 587
Break 389
Inaccurate Flow Rate 378
Failure to Infuse 369
Device Contamination with Chemical or Other Material 360
Leak/Splash 351
Insufficient Flow or Under Infusion 295
Disconnection 197
Adverse Event Without Identified Device or Use Problem 180
Component Missing 123
Crack 94
Improper Flow or Infusion 87
Detachment of Device or Device Component 86
Contamination /Decontamination Problem 61
Loose or Intermittent Connection 60

Yearly Trend

93
1993: 6
94
1994: 82
95
1995: 45
96
1996: 33
97
1997: 39
98
1998: 39
99
1999: 68
00
2000: 67
01
2001: 107
02
2002: 151
03
2003: 171
04
2004: 135
05
2005: 288
06
2006: 156
07
2007: 110
08
2008: 444
09
2009: 798
10
2010: 1,827
11
2011: 2,265
12
2012: 1,976
13
2013: 1,956
14
2014: 2,695
15
2015: 2,980
16
2016: 2,147
17
2017: 1,653
18
2018: 1,473
19
2019: 974
20
2020: 2,732
21
2021: 1,802
22
2022: 1,288
23
2023: 1,248
24
2024: 1,424
25
2025: 1,434
26
2026: 212

Related Entities for Pump, Infusion, Elastomeric

Event Locations

20,319 (61.9%)
I 10,500 (32.0%)
HOSPITAL 942 (2.9%)
NO INFORMATION 564 (1.7%)
HOME 251 (0.8%)
UNKNOWN 70 (0.2%)
OUTPATIENT TREATMENT FACILITY 69 (0.2%)
OTHER 54 (0.2%)
INVALID DATA 27 (0.1%)
NOT APPLICABLE 15 (0.0%)
AMBULATORY SURGICAL FACILITY 9 (0.0%)
AMBULATORY HEALTH CARE FACILITY 2 (0.0%)
NURSING HOME 2 (0.0%)
CHEMOTHERAPY CENTER 1 (0.0%)

Compare BAXTER HEALTHCARE - IRVINE vs BAXTER HEALTHCARE CORPORATION →

Nationwide devices with similar MAUDE profiles

Two openFDA-derived peer sets for Pump, Infusion, Elastomeric, 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 (32,825 here).

Similar death-typed counts

Nearest other device types by death-typed report count (58 here), distinct from the volume row.

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