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

The FDA's MAUDE (Manufacturer and User Facility Device Experience) database collects reports of adverse events involving medical devices. For System, Dialysate Delivery, Sealed, there are 3,214 total reports including 149 death reports and 666 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, Sealed?

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.

2014 data FDA MAUDE openFDA

System, Dialysate Delivery, Sealed

Name: System, Dialysate Delivery, Sealed - 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, Sealed LIGHT-BOOK · MAUDE

#375 of 1000 · 3,214 reports · 1993–2014

BOOK 3,214 reports
RANK #375 of 1000
DEATH 149 death-typed
INJ 666 injury-typed
MALF 1,997 malfunction
SPAN 1993–2014
PEAK 2006: 917
PHOTO Monitor, Bed Patient

Nearest event-volume peer: Monitor, Bed Patient (33 report gap)

System, Dialysate Delivery, Sealed sits #375 of 1000 among tracked device types with 3,214 MAUDE reports spanning 1993–2014. 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 4.6% corpus 1.5% · above corpus mean (+3.1 pp)
INJ 20.7% corpus 30.4% · below corpus mean (-9.7 pp)
MALF 62.1% corpus 64.5% · below corpus mean (-2.4 pp)

Lead manufacturer FRESENIUS MEDICAL CARE-NORTH AMERICA accounts for 40% of manufacturer-tagged reports · Top event location is 41% of location-tagged rows .

Gauge, Depth

3,274
Injector And…

3,265
System (this)

3,214
Monitor

3,181
Accessories

3,152
Catheter

3,144

What this shows System, Dialysate Delivery, Sealed carries 3,214 MAUDE reports, ranked #375 of 1000.

Event Types

Malfunction 1,997 (62.1%)

Injury 666 (20.7%)

Other 362 (11.3%)

Death 149 (4.6%)

40 (1.2%)

Patient Outcomes

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

Other 1,795 (52.1%)

778 (22.6%)

Hospitalization 266 (7.7%)

Required Intervention 221 (6.4%)

R 128 (3.7%)

Death 127 (3.7%)

L 46 (1.3%)

Life Threatening 42 (1.2%)

O 28 (0.8%)

H 8 (0.2%)

S 2 (0.1%)

Disability 2 (0.1%)

Invalid Data 1 (0.0%)

Yearly Trend

1993: 3

1994: 13

1995: 22

1996: 343

1997: 604

1998: 274

1999: 212

2000: 90

2001: 72

2002: 57

2003: 46

2004: 75

2005: 93

2006: 917

2007: 204

2008: 109

2009: 55

2010: 17

2012: 3

2013: 3

2014: 2

Top Manufacturers

FRESENIUS MEDICAL CARE-NORTH AMERICA 137

FRESENIUS MEDICAL CARE NORTH AMERICA 109

NXSTAGE MEDICAL, INC. 99

Event Locations

1,307 (40.7%)

HOSPITAL 819 (25.5%)

OUTPATIENT TREATMENT FACILITY 533 (16.6%)

INVALID DATA 474 (14.7%)

DIALYSIS CENTER 25 (0.8%)

UNKNOWN 17 (0.5%)

OTHER 13 (0.4%)

OUTPATIENT DIAGNOSTIC FACILITY 11 (0.3%)

HOME 4 (0.1%)

AMBULATORY SURGICAL FACILITY 3 (0.1%)

DIALYSIS UNIT 3 (0.1%)

NOT APPLICABLE 2 (0.1%)

I 1 (0.0%)

NO INFORMATION 1 (0.0%)

NURSING HOME 1 (0.0%)

Compare FRESENIUS MEDICAL CARE-NORTH AMERICA vs FRESENIUS MEDICAL CARE NORTH AMERICA →

Nationwide devices with similar MAUDE profiles

Two openFDA-derived peer sets for System, Dialysate Delivery, Sealed, 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 (3,214 here).

Monitor, Bed Patient 3,181 Injector And Syringe, Angiographic 3,265 Gauge, Depth 3,274 Accessories, Implant, Dental, Endosseous 3,152

Similar death-typed counts

Nearest other device types by death-typed report count (149 here), distinct from the volume row.

Mattress 154 Catheter, Embolectomy 142 Percutaneous Cardiac Ablation Catheter For… 156 Dialyzer, Capillary, Hollow Fiber 157

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

Disclaimer: MAUDE figures for System, Dialysate Delivery, Sealed 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, Sealed; 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.