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2026 data FDA MAUDE openFDA

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.

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FDA MAUDE casebook

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

#24 of 1000 · 163,240 reports · 1992–2026

  • BOOK 163,240 reports
  • RANK #24 of 1000
  • DEATH 3,401 death-typed
  • INJ 18,975 injury-typed
  • MALF 140,521 malfunction
  • SPAN 1992–2026
  • PEAK 2014: 28,289
  • PHOTO Staple, Implantable

Nearest event-volume peer: Staple, Implantable (1,663 report gap)

System, Peritoneal, Automatic Delivery sits #24 of 1000 among tracked device types with 163,240 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 2.1% corpus 1.5% · above corpus mean (+0.6 pp)
  • INJ 11.6% corpus 30.4% · below corpus mean (-18.8 pp)
  • MALF 86.1% corpus 64.5% · above corpus mean (+21.6 pp)

Lead product-problem code Fluid/Blood Leak is 39% of coded problems · Lead manufacturer BAXTER HEALTHCARE - MOUNTAIN HOME accounts for 27% 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 163,240 MAUDE reports, ranked #24 of 1000.

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

Event Types

Malfunction 140,521 (86.1%)
Injury 18,975 (11.6%)
Death 3,401 (2.1%)
Other 190 (0.1%)
153 (0.1%)

Patient Outcomes

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

140,969 (81.1%)
Hospitalization 10,246 (5.9%)
R 7,554 (4.3%)
Required Intervention 6,786 (3.9%)
Death 3,426 (2.0%)
H 2,117 (1.2%)
Other 1,662 (1.0%)
O 512 (0.3%)
L 342 (0.2%)
Life Threatening 86 (0.0%)
D 67 (0.0%)
S 43 (0.0%)
Congenital Anomaly 5 (0.0%)
Disability 4 (0.0%)

Top Product Problems

Fluid/Blood Leak 19,622
Adverse Event Without Identified Device or Use Problem 10,932
Thermal Decomposition of Device 4,843
Device Displays Incorrect Message 3,391
Improper or Incorrect Procedure or Method 1,923
Overfill 1,580
Disconnection 1,468
Protective Measures Problem 1,311
Loose or Intermittent Connection 911
Device Operates Differently Than Expected 629
Device Contamination with Chemical or Other Material 497
Improper Flow or Infusion 331
Material Puncture/Hole 319
Air/Gas in Device 317
Device Handling Problem 306
Detachment of Device or Device Component 293
Failure to Disconnect 278
Component Missing 271
Material Split, Cut or Torn 270
Break 224

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: 341
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: 457

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 16,532
ERIKA DE REYNOSA, S.A. DE C.V. 15,186
BAXTER HEALTHCARE - SINGAPORE 14,170
BAXTER HEALTHCARE 8,403
FRESENIUS MEDICAL CARE NORTH AMERICA 3,513
BAXTER HEALTHCARE CORP. 2,912

Event Locations

123,600 (75.7%)
I 37,954 (23.3%)
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 similar MAUDE profiles

Two openFDA-derived peer sets for System, Peritoneal, Automatic Delivery, 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 (163,240 here).

Staple, Implantable 164,903 Defibrillator 164,952 Mesh, Surgical, Polymeric 168,757 Prosthesis 153,958

Similar death-typed counts

Nearest other device types by death-typed report count (3,401 here), distinct from the volume row.

Wearable Automated External Defibrillator 3,639 Permanent Defibrillator Electrodes 3,030 Pulse Generator, Permanent, Implantable 3,860 Stimulator 2,889

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.