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2026 data FDA MAUDE openFDA FDA Class II

Dialysate Concentrate For Hemodialysis (Liquid Or Powder)

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).

Browse devices → Device safety hub

FDA MAUDE casebook

openFDA event book Dialysate Concentrate For Hemodialysis MID-BOOK · MAUDE

#108 of 1000 · 30,008 reports · 1992–2026

  • BOOK 30,008 reports
  • RANK #108 of 1000
  • DEATH 23,081 death-typed
  • INJ 5,346 injury-typed
  • MALF 1,490 malfunction
  • SPAN 1992–2026
  • PEAK 2014: 15,916
  • PHOTO Drill

Nearest event-volume peer: Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece (225 report gap)

Dialysate Concentrate For Hemodialysis (Liquid Or Powder) sits #108 of 1000 among tracked device types with 30,008 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 →

Death-coded reports run above the device-type norm

Dialysate Concentrate For Hemodialysis carries 76.9% DEATH-coded reports, 75.4pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 76.9% corpus 1.5% · above corpus mean (+75.4 pp)
  • INJ 17.8% corpus 30.3% · below corpus mean (-12.5 pp)
  • MALF 5.0% corpus 64.8% · below corpus mean (-59.9 pp)

Lead product-problem code Insufficient Device Problem Information is 92% of coded problems · Lead manufacturer FRESENIUS MEDICAL CARE NORTH AMERICA accounts for 99% of manufacturer-tagged reports · Top event location is 84% of location-tagged rows .

Dialysate Concentrate For Hemodialysis in the event-volume neighbourhood

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

reports

What this shows Dialysate Concentrate For Hemodialysis (Liquid Or Powder) carries 30,008 MAUDE reports, ranked #108 of 1000.

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

Event Types

Death 23,081 (76.9%)
Injury 5,346 (17.8%)
Malfunction 1,490 (5.0%)
52 (0.2%)
Other 39 (0.1%)

Patient Outcomes

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

Death 22,969 (40.4%)
L 11,268 (19.8%)
R 5,943 (10.4%)
O 4,647 (8.2%)
S 4,585 (8.1%)
Hospitalization 4,524 (8.0%)
1,284 (2.3%)
Life Threatening 666 (1.2%)
Other 439 (0.8%)
H 435 (0.8%)
Required Intervention 113 (0.2%)
Congenital Anomaly 9 (0.0%)
D 5 (0.0%)
Disability 4 (0.0%)

Top Product Problems

Insufficient Device Problem Information 27,821
Adverse Event Without Identified Device or Use Problem 474
Break 310
Leak/Splash 270
Fluid/Blood Leak 242
Chemical Problem 211
Thermal Decomposition of Device 179
Precipitate in Device or Device Ingredient 152
Smoking 102
No Apparent Adverse Event 65
Material Separation 49
Melted 47
Device Contaminated During Manufacture or Shipping 43
Device Operates Differently Than Expected 35
Defective Component 31
Detachment of Device or Device Component 30
Appropriate Device Problem Term/Code Not Available 29
Fire 29
Sparking 27
Improper or Incorrect Procedure or Method 26

Yearly Trend

92
1992: 1
93
1993: 2
94
1994: 9
95
1995: 8
96
1996: 3
97
1997: 22
98
1998: 4
99
1999: 7
00
2000: 1
01
2001: 1
02
2002: 8
03
2003: 7
04
2004: 1
05
2005: 4
06
2006: 7
07
2007: 5
08
2008: 8
09
2009: 3
10
2010: 107
11
2011: 223
12
2012: 70
13
2013: 3,897
14
2014: 15,916
15
2015: 8,340
16
2016: 240
17
2017: 80
18
2018: 97
19
2019: 79
20
2020: 244
21
2021: 63
22
2022: 25
23
2023: 59
24
2024: 259
25
2025: 98
26
2026: 110

Reports fell to 98 in 2025, down from an average of 159 in the two years before.

Related Entities for Dialysate Concentrate For Hemodialysis (Liquid Or Powder)

Top Manufacturers

FRESENIUS MEDICAL CARE NORTH AMERICA 28,014
CONCORD MANUFACTURING 258

Event Locations

25,329 (84.4%)
NO INFORMATION 2,863 (9.5%)
I 1,651 (5.5%)
HOSPITAL 90 (0.3%)
OUTPATIENT TREATMENT FACILITY 33 (0.1%)
INVALID DATA 13 (0.0%)
HOME 8 (0.0%)
OTHER 8 (0.0%)
DIALYSIS CENTER 6 (0.0%)
DIALYSIS UNIT 3 (0.0%)
OUTPATIENT DIAGNOSTIC FACILITY 3 (0.0%)
UNKNOWN 1 (0.0%)

Compare FRESENIUS MEDICAL CARE NORTH AMERICA vs CONCORD MANUFACTURING →

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Dialysate Concentrate For Hemodialysis: 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 (30,008 here).

Drill, Surgical, Ent Including Handpiece 29,783 Wheelchair, Powered 30,542 Reamer 29,419 Bronchoscope 31,113

Similar death-typed counts

Nearest other device types by death-typed report count (23,081 here), distinct from the volume row.

Ventricular Bypass 23,004 Coronary Drug-Eluting Stent 11,230 Implantable Cardioverter Defibrillator 10,094 Permanent Pacemaker Electrode 9,381

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

Disclaimer: MAUDE figures for Dialysate Concentrate For Hemodialysis 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 Dialysate Concentrate For Hemodialysis; 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.