What are FDA adverse event reports for System, Dialysate Delivery, Single Patient?

The FDA's MAUDE (Manufacturer and User Facility Device Experience) database collects reports of adverse events involving medical devices. For System, Dialysate Delivery, Single Patient, there are 1,072 total reports including 93 death reports and 296 injury reports. These reports are submitted by manufacturers, healthcare facilities, and patients. A high number of reports does not necessarily mean a device is unsafe, widely used devices naturally generate more reports.

How should I interpret MAUDE data for System, Dialysate Delivery, Single Patient?

MAUDE reports are raw adverse event submissions, not confirmed safety findings. A report that a device was involved in a death does not mean the device caused the death. Reports vary in quality and completeness. The FDA uses MAUDE data as one input among many in its safety surveillance, it does not draw conclusions from individual reports. Always consult your healthcare provider about device safety questions.

2021 data FDA MAUDE openFDA

System, Dialysate Delivery, Single Patient

Name: System, Dialysate Delivery, Single Patient - FDA MAUDE Adverse Event Reports
Creator: PlainHospital
License: https://creativecommons.org/publicdomain/zero/1.0/

Adverse-event figures are drawn from the U.S. Food & Drug Administration (FDA) MAUDE database, refreshed March 2026, see our methodology.

Compiled by PlainHospital · August 14, 2026

OpenFDA device adverse-event casebook.

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FDA MAUDE casebook

openFDA event book System, Dialysate Delivery, Single Patient LIGHT-BOOK · MAUDE

#641 of 1000 · 1,072 reports · 1992–2021

BOOK 1,072 reports
RANK #641 of 1000
DEATH 93 death-typed
INJ 296 injury-typed
MALF 607 malfunction
SPAN 1992–2021
PEAK 2001: 155
PHOTO Laryngoscope

Nearest event-volume peer: Laryngoscope, Non-Rigid (2 report gap)

System, Dialysate Delivery, Single Patient sits #641 of 1000 among tracked device types with 1,072 MAUDE reports spanning 1992–2021. 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 8.7% corpus 1.5% · above corpus mean (+7.2 pp)
INJ 27.6% corpus 30.4% · below corpus mean (-2.8 pp)
MALF 56.6% corpus 64.5% · below corpus mean (-7.9 pp)

Lead product-problem code Adverse Event Without Identified Device or Use Problem is 42% of coded problems · Lead manufacturer BAXTER HEALTHCARE CORP. accounts for 50% of manufacturer-tagged reports · Top event location is 77% of location-tagged rows .

Instrument

1,086
Apparatus

1,081
Automated Uri…

1,080
Introducer

1,076
Laryngoscope

1,074
System (this)

1,072

What this shows System, Dialysate Delivery, Single Patient carries 1,072 MAUDE reports, ranked #641 of 1000.

Event Types

Malfunction 607 (56.6%)

Injury 296 (27.6%)

Death 93 (8.7%)

Other 66 (6.2%)

10 (0.9%)

Patient Outcomes

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

555 (47.0%)

Required Intervention 147 (12.5%)

Hospitalization 130 (11.0%)

Other 129 (10.9%)

Death 92 (7.8%)

R 62 (5.3%)

O 21 (1.8%)

Life Threatening 20 (1.7%)

L 14 (1.2%)

H 7 (0.6%)

S 1 (0.1%)

Disability 1 (0.1%)

Invalid Data 1 (0.1%)

Yearly Trend

1992: 2

1993: 4

1994: 20

1995: 11

1996: 27

1997: 53

1998: 82

1999: 96

2000: 77

2001: 155

2002: 103

2003: 133

2004: 150

2005: 59

2006: 17

2007: 8

2008: 26

2009: 22

2010: 9

2011: 4

2013: 2

2014: 1

2015: 1

2018: 5

2019: 1

2021: 4

Top Manufacturers

BAXTER HEALTHCARE CORP. 346

BAXTER HEALTHCARE CORPORATION 251

BAXTER HEALTHCARE CORP 64

BAXTER HEALTHCARE 30

Event Locations

823 (76.8%)

OUTPATIENT TREATMENT FACILITY 153 (14.3%)

HOSPITAL 44 (4.1%)

INVALID DATA 19 (1.8%)

DIALYSIS CENTER 7 (0.7%)

NO INFORMATION 7 (0.7%)

I 4 (0.4%)

UNKNOWN 4 (0.4%)

DIALYSIS UNIT 3 (0.3%)

OTHER 3 (0.3%)

HOME 2 (0.2%)

OUTPATIENT DIAGNOSTIC FACILITY 2 (0.2%)

NOT APPLICABLE 1 (0.1%)

Compare BAXTER HEALTHCARE CORP. vs BAXTER HEALTHCARE CORPORATION →

Nationwide devices with similar MAUDE profiles

Two openFDA-derived peer sets for System, Dialysate Delivery, Single Patient, 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 (1,072 here).

Laryngoscope, Non-Rigid 1,074 Introducer, Syringe Needle 1,076 Automated Urinalysis System 1,080 Apparatus, Suction, Patient Care 1,081

Similar death-typed counts

Nearest other device types by death-typed report count (93 here), distinct from the volume row.

Agent, Absorbable Hemostatic, Collagen Based 92 Cement, Bone, Vertebroplasty 94 Coronary Covered Stent 92 Shockwave Intravascular Lithotripsy System 91

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

Disclaimer: MAUDE figures for System, Dialysate Delivery, Single Patient 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, Dialysate Delivery, Single Patient; 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.

System, Dialysate Delivery, Single Patient

Event-type mix vs corpus