System, Dialysate Delivery, Single Patient
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 §876.5820 (Gastroenterology, Urology panel).
FDA MAUDE casebook
openFDA event book System, Dialysate Delivery, Single Patient LIGHT-BOOK · MAUDE
#648 of 1000 · 1,072 reports · 1992–2021
- BOOK 1,072 reports
- RANK #648 of 1000
- DEATH 93 death-typed
- INJ 296 injury-typed
- MALF 607 malfunction
- SPAN 1992–2021
- PEAK 2001: 155
- PHOTO Occluder
Nearest event-volume peer: Occluder, Patent Ductus, Arteriosus (1 report gap)
System, Dialysate Delivery, Single Patient sits #648 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 →
Malfunction reports sit below the device-type norm
System, Dialysate Delivery, Single Patient carries 56.6% MALFUNCTION-coded reports, 8.2pp below the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.
- DEATH 8.7% corpus 1.5% · above corpus mean (+7.2 pp)
- INJ 27.6% corpus 30.3% · below corpus mean (-2.7 pp)
- MALF 56.6% corpus 64.8% · below corpus mean (-8.2 pp)
Lead product-problem code Unknown (for use when the device problem is not known) is 13% of coded problems · Lead manufacturer BAXTER HEALTHCARE CORP. accounts for 50% of manufacturer-tagged reports · Top event location is 77% of location-tagged rows .
System, Dialysate Delivery, Single Patient in the event-volume neighbourhood
FDA MAUDE report totals among this device type and nearest nationwide peers
- Automated Uri…
Automated Urinalysis System
1,086 reports
- Introducer
Introducer, Syringe Needle
1,079 reports
- Hemostatic De…
Hemostatic Device For Endoscopic Gastrointestinal Use
1,077 reports
- System (this)
System, Dialysate Delivery, Single Patient
1,072 reports
- Occluder
Occluder, Patent Ductus, Arteriosus
1,071 reports
- Catheter
Catheter, Oximeter, Fiber-Optic
1,067 reports
What this shows System, Dialysate Delivery, Single Patient carries 1,072 MAUDE reports, ranked #648 of 1000.
Event Types
Patient Outcomes
FDA patient-outcome codes (separate from event_type). Percentages use this chart's row total.
Top Product Problems
Yearly Trend
Reports fell to 1 in 2019, down from an average of 3 in the two years before.
Related Entities for System, Dialysate Delivery, Single Patient
Top Manufacturers
Event Locations
Compare BAXTER HEALTHCARE CORP. vs BAXTER HEALTHCARE CORPORATION →
Nationwide devices with a comparable volume-and-death footprint
Two openFDA-derived peer sets for System, Dialysate Delivery, Single Patient: 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 (1,072 here).
Similar death-typed counts
Nearest other device types by death-typed report count (93 here), distinct from the volume row.
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.