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2023 data FDA MAUDE openFDA FDA Class II

Hemodialyzer, Re-Use, High Flux

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 Hemodialyzer, Re-Use, High Flux LIGHT-BOOK · MAUDE

#620 of 1000 · 1,219 reports · 1999–2023

  • BOOK 1,219 reports
  • RANK #620 of 1000
  • DEATH 3 death-typed
  • INJ 23 injury-typed
  • MALF 1,164 malfunction
  • SPAN 1999–2023
  • PEAK 2008: 659
  • PHOTO Accessories

Nearest event-volume peer: Accessories, Blood Circuit, Hemodialysis (1 report gap)

Hemodialyzer, Re-Use, High Flux sits #620 of 1000 among tracked device types with 1,219 MAUDE reports spanning 1999–2023. 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 → · Similar-volume device →

Malfunction reports run above the device-type norm

Hemodialyzer, Re-Use, High Flux carries 95.5% MALFUNCTION-coded reports, 30.7pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 0.2% corpus 1.5% · below corpus mean (-1.3 pp)
  • INJ 1.9% corpus 30.3% · below corpus mean (-28.4 pp)
  • MALF 95.5% corpus 64.8% · above corpus mean (+30.7 pp)

Lead product-problem code Fluid/Blood Leak is 82% of coded problems · Top event location is 97% of location-tagged rows .

Hemodialyzer, Re-Use, High Flux in the event-volume neighbourhood

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

reports

What this shows Hemodialyzer, Re-Use, High Flux carries 1,219 MAUDE reports, ranked #620 of 1000.

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

Event Types

Malfunction 1,164 (95.5%)
Other 29 (2.4%)
Injury 23 (1.9%)
Death 3 (0.2%)

Patient Outcomes

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

Other 1,116 (91.0%)
83 (6.8%)
Required Intervention 10 (0.8%)
Hospitalization 6 (0.5%)
R 5 (0.4%)
L 2 (0.2%)
Death 2 (0.2%)
Life Threatening 2 (0.2%)

Top Product Problems

Fluid/Blood Leak 1,059
Material Rupture 87
Membrane tear(s) 53
Component(s), broken 22
Leak/Splash 21
Unknown (for use when the device problem is not known) 10
Rupture, cause unknown 8
Tears, rips, holes in device, device material 6
Alarm, audible 5
Break 5
Output, low 3
Adverse Event Without Identified Device or Use Problem 2
Blood in tubing 2
Device Displays Incorrect Message 2
Improper or Incorrect Procedure or Method 2
Patient-Device Incompatibility 2
Reaction 2
Device Contamination with Body Fluid 1
Device Difficult to Setup or Prepare 1
Device Operates Differently Than Expected 1

Yearly Trend

99
1999: 1
02
2002: 1
04
2004: 2
06
2006: 22
07
2007: 509
08
2008: 659
10
2010: 5
11
2011: 16
13
2013: 1
14
2014: 1
15
2015: 1
23
2023: 1

Reports in 2015 (1) held close to the prior two-year average of 1.

Related Entities for Hemodialyzer, Re-Use, High Flux

Event Locations

1,178 (96.6%)
HOSPITAL 32 (2.6%)
INVALID DATA 5 (0.4%)
NO INFORMATION 3 (0.2%)
OUTPATIENT TREATMENT FACILITY 1 (0.1%)

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Hemodialyzer, Re-Use, High Flux: 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 (1,219 here).

Accessories, Blood Circuit, Hemodialysis 1,220 System, X-Ray, Stationary 1,218 Cardiovascular Procedure Kit 1,221 Lithotriptor, Ultrasonic 1,213

Similar death-typed counts

Nearest other device types by death-typed report count (3 here), distinct from the volume row.

Analyzer, Pacemaker Generator Function 3 Apparatus, Traction, Non-Powered 3 Bronchial Thermoplasty System 3 Bur, Ear, Nose And Throat 3

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

Disclaimer: MAUDE figures for Hemodialyzer, Re-Use, High Flux 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 Hemodialyzer, Re-Use, High Flux; 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.