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2014 data FDA MAUDE openFDA FDA Class II

System, Dialysate Delivery, Sealed

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 §876.5860 (Gastroenterology, Urology panel).

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FDA MAUDE casebook

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

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

  • BOOK 3,214 reports
  • RANK #387 of 1000
  • DEATH 149 death-typed
  • INJ 666 injury-typed
  • MALF 1,997 malfunction
  • SPAN 1993–2014
  • PEAK 2006: 917
  • PHOTO Integrated Continuous…

Nearest event-volume peer: Integrated Continuous Glucose Monitoring System With Sensor Containing Dexamethasone Acetate (0 report gap)

System, Dialysate Delivery, Sealed sits #387 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 →

Injury-coded reports sit below the device-type norm

System, Dialysate Delivery, Sealed carries 20.7% INJURY-coded reports, 9.6pp below the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 4.6% corpus 1.5% · above corpus mean (+3.1 pp)
  • INJ 20.7% corpus 30.3% · below corpus mean (-9.6 pp)
  • MALF 62.1% corpus 64.8% · below corpus mean (-2.7 pp)

Lead product-problem code Device Issue is 11% of coded problems · Lead manufacturer FRESENIUS MEDICAL CARE-NORTH AMERICA accounts for 56% of manufacturer-tagged reports · Top event location is 41% of location-tagged rows .

System, Dialysate Delivery, Sealed in the event-volume neighbourhood

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

reports

What this shows System, Dialysate Delivery, Sealed carries 3,214 MAUDE reports, ranked #387 of 1000.

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

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%)

Top Product Problems

Device Issue 326
Unknown (for use when the device problem is not known) 324
Replace 255
Alarm, audible 254
Device Alarm System 244
Other (for use when an appropriate device code cannot be identified) 244
Output, high 174
Leak/Splash 149
Repair 130
Air Leak 119
Fluid/Blood Leak 107
Device Displays Incorrect Message 96
Normal 79
Insufficient Flow or Under Infusion 78
Output, low 76
Bubble(s) 68
Use of Device Problem 68
Excess Flow or Over-Infusion 59
Inadequate Ultra Filtration 59
Disconnection 58

Yearly Trend

93
1993: 3
94
1994: 13
95
1995: 22
96
1996: 343
97
1997: 604
98
1998: 274
99
1999: 212
00
2000: 90
01
2001: 72
02
2002: 57
03
2003: 46
04
2004: 75
05
2005: 93
06
2006: 917
07
2007: 204
08
2008: 109
09
2009: 55
10
2010: 17
12
2012: 3
13
2013: 3
14
2014: 2

Reports fell to 3 in 2013, down from an average of 10 in the two years before.

Related Entities for System, Dialysate Delivery, Sealed

Top Manufacturers

FRESENIUS MEDICAL CARE-NORTH AMERICA 137
FRESENIUS MEDICAL CARE NORTH AMERICA 109

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 a comparable volume-and-death footprint

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

Integrated Continuous Glucose Monitoring Sy… 3,214 Stimulator, Electrical, Evoked Response 3,228 Unit, Cryosurgical, Accessories 3,228 Catheter, Hemodialysis, Non-Implanted 3,199

Similar death-typed counts

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

Catheter, Peripheral, Atherectomy 149 Injector And Syringe, Angiographic 146 Mattress 154 Catheter, Embolectomy 143

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.