2026 data FDA MAUDE openFDA

Dialyzer, High Permeability With Or Without Sealed Dialysate System

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 MAUDE casebook

openFDA event book Dialyzer MID-BOOK · MAUDE

#78 of 1000 · 42,530 reports · 1992–2026

  • BOOK 42,530 reports
  • RANK #78 of 1000
  • DEATH 2,561 death-typed
  • INJ 12,122 injury-typed
  • MALF 27,166 malfunction
  • SPAN 1992–2026
  • PEAK 2014: 6,154
  • PHOTO Powered Laser Surgica…

Nearest event-volume peer: Powered Laser Surgical Instrument (200 report gap)

Dialyzer, High Permeability With Or Without Sealed Dialysate System sits #78 of 1000 among tracked device types with 42,530 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 6.0% corpus 1.5% · above corpus mean (+4.5 pp)
  • INJ 28.5% corpus 30.4% · below corpus mean (-1.9 pp)
  • MALF 63.9% corpus 64.5% · below corpus mean (-0.6 pp)

Lead product-problem code Fluid/Blood Leak is 57% of coded problems · Lead manufacturer BAXTER HEALTHCARE - CLEVELAND accounts for 26% of manufacturer-tagged reports · Top event location is 73% of location-tagged rows .

Dialyzer in the event-volume neighbourhood

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

reports

What this shows Dialyzer, High Permeability With Or Without Sealed Dialysate System carries 42,530 MAUDE reports, ranked #78 of 1000.

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

Event Types

Malfunction 27,166 (63.9%)
Injury 12,122 (28.5%)
Death 2,561 (6.0%)
Other 582 (1.4%)
99 (0.2%)

Patient Outcomes

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

25,662 (53.2%)
Other 5,663 (11.7%)
Hospitalization 5,120 (10.6%)
R 3,336 (6.9%)
Required Intervention 3,289 (6.8%)
Death 2,531 (5.2%)
L 822 (1.7%)
O 641 (1.3%)
S 465 (1.0%)
H 451 (0.9%)
Life Threatening 216 (0.4%)
D 33 (0.1%)
Disability 15 (0.0%)
Congenital Anomaly 9 (0.0%)
Invalid Data 2 (0.0%)

Top Product Problems

Fluid/Blood Leak 11,041
Adverse Event Without Identified Device or Use Problem 2,029
Thermal Decomposition of Device 1,352
Break 790
Inadequate Ultra Filtration 694
Leak/Splash 511
Crack 454
Device Contamination with Chemical or Other Material 407
Melted 373
Device Operates Differently Than Expected 211
Disconnection 198
Mechanical Problem 188
Smoking 179
Labelling, Instructions for Use or Training Problem 177
Reflux within Device 172
Air/Gas in Device 150
Obstruction of Flow 147
Insufficient Information 142
Improper or Incorrect Procedure or Method 131
Protective Measures Problem 117

Yearly Trend

92
1992: 47
93
1993: 130
94
1994: 95
95
1995: 26
96
1996: 244
97
1997: 88
98
1998: 180
99
1999: 173
00
2000: 212
01
2001: 480
02
2002: 290
03
2003: 147
04
2004: 159
05
2005: 264
06
2006: 760
07
2007: 916
08
2008: 1,042
09
2009: 522
10
2010: 823
11
2011: 2,270
12
2012: 1,765
13
2013: 2,360
14
2014: 6,154
15
2015: 4,182
16
2016: 766
17
2017: 963
18
2018: 1,716
19
2019: 1,587
20
2020: 1,633
21
2021: 1,944
22
2022: 2,180
23
2023: 2,692
24
2024: 2,441
25
2025: 2,822
26
2026: 457

Related Entities for Dialyzer, High Permeability With Or Without Sealed Dialysate System

Event Locations

31,238 (73.4%)
I 8,111 (19.1%)
HOSPITAL 1,747 (4.1%)
OUTPATIENT TREATMENT FACILITY 775 (1.8%)
NO INFORMATION 287 (0.7%)
OTHER 176 (0.4%)
INVALID DATA 105 (0.2%)
HOME 23 (0.1%)
DIALYSIS CENTER 19 (0.0%)
OUTPATIENT DIAGNOSTIC FACILITY 18 (0.0%)
UNKNOWN 13 (0.0%)
AMBULATORY SURGICAL FACILITY 5 (0.0%)
DIALYSIS UNIT 5 (0.0%)
NURSING HOME 4 (0.0%)
NOT APPLICABLE 3 (0.0%)
CLINIC - WALK IN, OTHER 1 (0.0%)

Compare BAXTER HEALTHCARE - CLEVELAND vs BAXTER HEALTHCARE CORPORATION →

Nationwide devices with similar MAUDE profiles

Two openFDA-derived peer sets for Dialyzer, 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 (42,530 here).

Similar death-typed counts

Nearest other device types by death-typed report count (2,561 here), distinct from the volume row.

Disclaimer: MAUDE figures for Dialyzer 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 Dialyzer; 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.