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2026 data FDA MAUDE openFDA

Dialyzer, Capillary, Hollow Fiber

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 Dialyzer, Capillary, Hollow Fiber LIGHT-BOOK · MAUDE

#233 of 1000 · 8,369 reports · 1992–2026

  • BOOK 8,369 reports
  • RANK #233 of 1000
  • DEATH 157 death-typed
  • INJ 3,159 injury-typed
  • MALF 4,605 malfunction
  • SPAN 1992–2026
  • PEAK 1996: 1,522
  • PHOTO Acid

Nearest event-volume peer: Acid, Hyaluronic, Intraarticular (13 report gap)

Dialyzer, Capillary, Hollow Fiber sits #233 of 1000 among tracked device types with 8,369 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 1.9% corpus 1.5% · near corpus mean (+0.4 pp)
  • INJ 37.7% corpus 30.4% · above corpus mean (+7.3 pp)
  • MALF 55.0% corpus 64.5% · below corpus mean (-9.5 pp)

Lead product-problem code Fluid/Blood Leak is 67% of coded problems · Lead manufacturer FRESENIUS MEDICAL CARE NORTH AMERICA accounts for 58% of manufacturer-tagged reports · Top event location is 55% of location-tagged rows .

Dialyzer, Capillary, Hollow Fiber in the event-volume neighbourhood

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

reports

What this shows Dialyzer, Capillary, Hollow Fiber carries 8,369 MAUDE reports, ranked #233 of 1000.

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

Event Types

Malfunction 4,605 (55.0%)
Injury 3,159 (37.7%)
Other 370 (4.4%)
Death 157 (1.9%)
78 (0.9%)

Patient Outcomes

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

4,652 (52.0%)
Required Intervention 2,366 (26.5%)
Other 778 (8.7%)
Hospitalization 339 (3.8%)
R 304 (3.4%)
Death 155 (1.7%)
L 135 (1.5%)
O 100 (1.1%)
Life Threatening 75 (0.8%)
H 17 (0.2%)
S 11 (0.1%)
Congenital Anomaly 9 (0.1%)
Disability 2 (0.0%)
Invalid Data 1 (0.0%)

Top Product Problems

Fluid/Blood Leak 815
Adverse Event Without Identified Device or Use Problem 309
Break 32
Device Contamination with Chemical or Other Material 23
Crack 17
Occlusion Within Device 13
Leak/Splash 5
Loose or Intermittent Connection 2
Air/Gas in Device 1
Complete Blockage 1
Connection Problem 1
Contamination 1
Device Issue 1
Material Rupture 1
No Flow 1
Patient-Device Incompatibility 1
Use of Device Problem 1

Yearly Trend

92
1992: 19
93
1993: 30
94
1994: 206
95
1995: 136
96
1996: 1,522
97
1997: 340
98
1998: 440
99
1999: 465
00
2000: 559
01
2001: 504
02
2002: 273
03
2003: 183
04
2004: 201
05
2005: 157
06
2006: 91
07
2007: 17
08
2008: 11
09
2009: 3
10
2010: 32
11
2011: 47
12
2012: 211
13
2013: 553
14
2014: 633
15
2015: 561
16
2016: 562
17
2017: 182
18
2018: 11
19
2019: 20
20
2020: 16
21
2021: 12
22
2022: 2
23
2023: 51
24
2024: 152
25
2025: 145
26
2026: 22

Related Entities for Dialyzer, Capillary, Hollow Fiber

Top Manufacturers

FRESENIUS MEDICAL CARE NORTH AMERICA 1,668
BAXTER HEALTHCARE CORPORATION 478
BAXTER HEALTHCARE CORP. 415
OGDEN MANUFACTURING PLANT 291

Event Locations

4,612 (55.1%)
OUTPATIENT TREATMENT FACILITY 1,965 (23.5%)
I 880 (10.5%)
NO INFORMATION 247 (3.0%)
INVALID DATA 235 (2.8%)
HOSPITAL 217 (2.6%)
OTHER 129 (1.5%)
DIALYSIS CENTER 32 (0.4%)
UNKNOWN 20 (0.2%)
DIALYSIS UNIT 10 (0.1%)
HOME 10 (0.1%)
OUTPATIENT DIAGNOSTIC FACILITY 8 (0.1%)
NURSING HOME 2 (0.0%)
AMBULATORY SURGICAL FACILITY 1 (0.0%)
NOT APPLICABLE 1 (0.0%)

Compare FRESENIUS MEDICAL CARE NORTH AMERICA vs BAXTER HEALTHCARE CORPORATION →

Nationwide devices with similar MAUDE profiles

Two openFDA-derived peer sets for Dialyzer, Capillary, Hollow Fiber, 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 (8,369 here).

Acid, Hyaluronic, Intraarticular 8,356 Stent, Carotid 8,339 Catheter, Thrombus Retriever 8,409 Guide, Surgical, Instrument 8,257

Similar death-typed counts

Nearest other device types by death-typed report count (157 here), distinct from the volume row.

Percutaneous Cardiac Ablation Catheter For… 156 Mattress 154 Tube Tracheostomy And Tube Cuff 161 Tube, Tracheostomy 162

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

Disclaimer: MAUDE figures for Dialyzer, Capillary, Hollow Fiber 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, Capillary, Hollow Fiber; 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.