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2026 data FDA MAUDE openFDA FDA Class II

System, Peritoneal, Automatic Delivery

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 Class II (moderate risk, special controls required), regulated under 21 CFR §876.5630 (Gastroenterology, Urology panel).

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FDA MAUDE casebook

openFDA event book System, Peritoneal, Automatic Delivery HEAVY-BOOK · MAUDE

#25 of 1000 · 164,500 reports · 1992–2026

  • BOOK 164,500 reports
  • RANK #25 of 1000
  • DEATH 3,434 death-typed
  • INJ 19,534 injury-typed
  • MALF 141,188 malfunction
  • SPAN 1992–2026
  • PEAK 2014: 28,289
  • PHOTO Integrated Continuous…

Nearest event-volume peer: Integrated Continuous Glucose Monitoring System, Factory Calibrated, Not For Use With Automated Insulin Delivery Systems (968 report gap)

System, Peritoneal, Automatic Delivery sits #25 of 1000 among tracked device types with 164,500 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 →

Malfunction reports run above the device-type norm

System, Peritoneal, Automatic Delivery carries 85.8% MALFUNCTION-coded reports, 21.0pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 2.1% corpus 1.5% · above corpus mean (+0.6 pp)
  • INJ 11.9% corpus 30.3% · below corpus mean (-18.4 pp)
  • MALF 85.8% corpus 64.8% · above corpus mean (+21.0 pp)

Lead product-problem code Device Displays Incorrect Message is 27% of coded problems · Lead manufacturer BAXTER HEALTHCARE - MOUNTAIN HOME accounts for 26% of manufacturer-tagged reports · Top event location is 76% of location-tagged rows .

System, Peritoneal, Automatic Delivery in the event-volume neighbourhood

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

reports

What this shows System, Peritoneal, Automatic Delivery carries 164,500 MAUDE reports, ranked #25 of 1000.

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

Event Types

Malfunction 141,188 (85.8%)
Injury 19,534 (11.9%)
Death 3,434 (2.1%)
Other 191 (0.1%)
153 (0.1%)

Patient Outcomes

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

141,541 (80.8%)
Hospitalization 10,421 (5.9%)
R 7,726 (4.4%)
Required Intervention 7,040 (4.0%)
Death 3,437 (2.0%)
H 2,288 (1.3%)
Other 1,675 (1.0%)
O 512 (0.3%)
L 344 (0.2%)
Life Threatening 88 (0.1%)
D 69 (0.0%)
S 43 (0.0%)
Congenital Anomaly 5 (0.0%)
Disability 4 (0.0%)

Top Product Problems

Device Displays Incorrect Message 46,877
Overfill 31,261
Fluid/Blood Leak 24,424
Adverse Event Without Identified Device or Use Problem 16,982
Improper or Incorrect Procedure or Method 12,502
Device Operates Differently Than Expected 12,289
Air Leak 8,942
Thermal Decomposition of Device 4,998
Disconnection 3,899
Insufficient Device Problem Information 2,937
Leak/Splash 1,897
Loose or Intermittent Connection 1,423
Protective Measures Problem 1,413
Use of Device Problem 1,259
Replace 1,050
Contamination 791
Failure to Prime 748
Device Contamination with Chemical or Other Material 697
Volume Accuracy Problem 688
Detachment Of Device Component 662

Yearly Trend

92
1992: 1
96
1996: 1
97
1997: 45
98
1998: 995
99
1999: 775
00
2000: 512
01
2001: 598
02
2002: 746
03
2003: 670
04
2004: 597
05
2005: 688
06
2006: 412
07
2007: 147
08
2008: 702
09
2009: 340
10
2010: 4,966
11
2011: 11,304
12
2012: 18,034
13
2013: 22,093
14
2014: 28,289
15
2015: 24,663
16
2016: 6,137
17
2017: 3,127
18
2018: 5,927
19
2019: 5,972
20
2020: 4,598
21
2021: 5,076
22
2022: 4,503
23
2023: 3,913
24
2024: 3,771
25
2025: 3,180
26
2026: 1,718

Reports in 2025 (3,180) held close to the prior two-year average of 3,842.

Related Entities for System, Peritoneal, Automatic Delivery

Top Manufacturers

BAXTER HEALTHCARE - MOUNTAIN HOME 41,646
BAXTER HEALTHCARE - LARGO 38,030
BAXTER HEALTHCARE CORPORATION 16,628
CONCORD MANUFACTURING 16,533
ERIKA DE REYNOSA, S.A. DE C.V. 16,113
BAXTER HEALTHCARE - SINGAPORE 14,170
BAXTER HEALTHCARE 8,402
FRESENIUS MEDICAL CARE NORTH AMERICA 3,513
BAXTER HEALTHCARE CORP. 2,912

Event Locations

124,861 (75.9%)
I 37,953 (23.1%)
HOME 1,122 (0.7%)
NO INFORMATION 408 (0.2%)
HOSPITAL 97 (0.1%)
OTHER 24 (0.0%)
OUTPATIENT TREATMENT FACILITY 8 (0.0%)
CLINIC - WALK IN, OTHER 6 (0.0%)
DIALYSIS CENTER 5 (0.0%)
HOSPICE 4 (0.0%)
NURSING HOME 3 (0.0%)
AMBULATORY SURGICAL FACILITY 2 (0.0%)
NOT APPLICABLE 2 (0.0%)
OUTPATIENT DIAGNOSTIC FACILITY 2 (0.0%)
UNKNOWN 2 (0.0%)
INVALID DATA 1 (0.0%)

Compare BAXTER HEALTHCARE - MOUNTAIN HOME vs BAXTER HEALTHCARE - LARGO →

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for System, Peritoneal, Automatic Delivery: nearest by total report volume and nearest by death-typed count, each floored at ≥100 reports so the neighborhoods stay in the advertised mass.

Similar report volume

Nearest other device types by FDA MAUDE report count (164,500 here).

Integrated Continuous Glucose Monitoring Sy… 165,468 Defibrillator 169,573 Staple, Implantable 169,612 Mesh, Surgical, Polymeric 170,120

Similar death-typed counts

Nearest other device types by death-typed report count (3,434 here), distinct from the volume row.

Wearable Automated External Defibrillator 3,738 Permanent Defibrillator Electrodes 3,081 Pulse Generator, Permanent, Implantable 3,912 Stimulator 2,917

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

Disclaimer: MAUDE figures for System, Peritoneal, Automatic Delivery 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 System, Peritoneal, Automatic Delivery; 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.