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2026 data FDA MAUDE openFDA

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.

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FDA MAUDE casebook

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

#106 of 1000 · 29,912 reports · 1992–2026

  • BOOK 29,912 reports
  • RANK #106 of 1000
  • DEATH 23,081 death-typed
  • INJ 5,345 injury-typed
  • MALF 1,395 malfunction
  • SPAN 1992–2026
  • PEAK 2014: 15,916
  • PHOTO Monitor

Nearest event-volume peer: Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) (81 report gap)

Dialysate Concentrate For Hemodialysis (Liquid Or Powder) sits #106 of 1000 among tracked device types with 29,912 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 →

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 77.2% corpus 1.5% · above corpus mean (+75.6 pp)
  • INJ 17.9% corpus 30.4% · below corpus mean (-12.6 pp)
  • MALF 4.7% corpus 64.5% · below corpus mean (-59.8 pp)

Lead product-problem code Leak/Splash is 16% of coded problems · Lead manufacturer FRESENIUS MEDICAL CARE NORTH AMERICA accounts for 98% 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 29,912 MAUDE reports, ranked #106 of 1000.

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

Event Types

Death 23,081 (77.2%)
Injury 5,345 (17.9%)
Malfunction 1,395 (4.7%)
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 (10.5%)
O 4,647 (8.2%)
S 4,585 (8.1%)
Hospitalization 4,524 (8.0%)
1,269 (2.2%)
Life Threatening 666 (1.2%)
H 435 (0.8%)
Other 361 (0.6%)
Required Intervention 113 (0.2%)
Congenital Anomaly 8 (0.0%)
D 5 (0.0%)
Disability 4 (0.0%)

Top Product Problems

Leak/Splash 242
Break 220
Chemical Problem 211
Adverse Event Without Identified Device or Use Problem 193
Thermal Decomposition of Device 173
Insufficient Information 124
Smoking 97
No Apparent Adverse Event 61
Melted 45
Device Contaminated During Manufacture or Shipping 43
Fluid/Blood Leak 28
Sparking 27
Fire 20
Material Rupture 16
Material Puncture/Hole 12
Burst Container or Vessel 8
Contamination 7
Nonstandard Device 7
Arcing 6
Improper or Incorrect Procedure or Method 6

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: 14

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

Top Manufacturers

FRESENIUS MEDICAL CARE NORTH AMERICA 28,014
NXSTAGE MEDICAL, INC. 318
CONCORD MANUFACTURING 258

Event Locations

25,235 (84.4%)
NO INFORMATION 2,863 (9.6%)
I 1,651 (5.5%)
HOSPITAL 88 (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 NXSTAGE MEDICAL, INC. →

Nationwide devices with similar MAUDE profiles

Two openFDA-derived peer sets for Dialysate Concentrate For Hemodialysis, 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 (29,912 here).

Monitor, Physiological, Patient 29,993 Wheelchair, Powered 30,441 Reamer 29,071 Drill, Surgical, Ent Including Handpiece 29,022

Similar death-typed counts

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

Ventricular Bypass 22,316 Coronary Drug-Eluting Stent 11,160 Implantable Cardioverter Defibrillator 10,004 Permanent Pacemaker Electrode 9,301

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.