2026 data FDA MAUDE openFDA

Pump, Infusion, Pca

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, Pca MID-BOOK · MAUDE

#103 of 1000 · 31,340 reports · 1992–2026

  • BOOK 31,340 reports
  • RANK #103 of 1000
  • DEATH 221 death-typed
  • INJ 855 injury-typed
  • MALF 29,894 malfunction
  • SPAN 1992–2026
  • PEAK 2022: 6,443
  • PHOTO Prosthesis

Nearest event-volume peer: Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented (85 report gap)

Pump, Infusion, Pca sits #103 of 1000 among tracked device types with 31,340 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 0.7% corpus 1.5% · below corpus mean (-0.8 pp)
  • INJ 2.7% corpus 30.4% · below corpus mean (-27.7 pp)
  • MALF 95.4% corpus 64.5% · above corpus mean (+30.9 pp)

Lead product-problem code Break is 17% of coded problems · Lead manufacturer CAREFUSION SD accounts for 59% of manufacturer-tagged reports · Top event location is 79% of location-tagged rows .

Pump, Infusion, Pca in the event-volume neighbourhood

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

reports

What this shows Pump, Infusion, Pca carries 31,340 MAUDE reports, ranked #103 of 1000.

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

Event Types

Malfunction 29,894 (95.4%)
Injury 855 (2.7%)
Other 283 (0.9%)
Death 221 (0.7%)
87 (0.3%)

Patient Outcomes

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

29,055 (91.9%)
Other 1,094 (3.5%)
Required Intervention 374 (1.2%)
R 341 (1.1%)
Life Threatening 335 (1.1%)
Death 217 (0.7%)
Hospitalization 96 (0.3%)
L 42 (0.1%)
S 18 (0.1%)
O 9 (0.0%)
H 5 (0.0%)
Invalid Data 5 (0.0%)
Congenital Anomaly 4 (0.0%)
Disability 4 (0.0%)
Not Applicable 1 (0.0%)

Top Product Problems

Break 6,483
Crack 4,776
Corroded 4,055
Device Markings/Labelling Problem 3,945
Failure to Align 2,519
Contamination 1,812
Deformation Due to Compressive Stress 1,740
Device Sensing Problem 1,557
Device Alarm System 1,540
Failure to Infuse 1,345
Appropriate Term/Code Not Available 997
Inaccurate Delivery 922
Physical Resistance/Sticking 888
No Apparent Adverse Event 773
Degraded 757
Naturally Worn 742
Failure to Calibrate 699
Failure to Sense 635
Circuit Failure 590
Display Difficult to Read 580

Yearly Trend

92
1992: 32
93
1993: 31
94
1994: 53
95
1995: 51
96
1996: 108
97
1997: 162
98
1998: 117
99
1999: 101
00
2000: 170
01
2001: 162
02
2002: 468
03
2003: 1,573
04
2004: 269
05
2005: 249
06
2006: 132
07
2007: 81
08
2008: 237
09
2009: 153
10
2010: 219
11
2011: 245
12
2012: 446
13
2013: 453
14
2014: 382
15
2015: 99
16
2016: 57
17
2017: 44
18
2018: 256
19
2019: 132
20
2020: 2,331
21
2021: 3,776
22
2022: 6,443
23
2023: 3,984
24
2024: 4,560
25
2025: 3,329
26
2026: 435

Related Entities for Pump, Infusion, Pca

Event Locations

24,646 (78.6%)
I 5,369 (17.1%)
HOSPITAL 1,053 (3.4%)
NO INFORMATION 77 (0.2%)
INVALID DATA 58 (0.2%)
HOME 53 (0.2%)
UNKNOWN 31 (0.1%)
OTHER 26 (0.1%)
OUTPATIENT TREATMENT FACILITY 17 (0.1%)
NURSING HOME 6 (0.0%)
NOT APPLICABLE 2 (0.0%)
AMBULATORY SURGICAL FACILITY 1 (0.0%)
OUTPATIENT DIAGNOSTIC FACILITY 1 (0.0%)

Compare CAREFUSION SD vs SMITHS MEDICAL ASD, INC. →

Nationwide devices with similar MAUDE profiles

Two openFDA-derived peer sets for Pump, Infusion, Pca, 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 (31,340 here).

Similar death-typed counts

Nearest other device types by death-typed report count (221 here), distinct from the volume row.

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