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2026 data FDA MAUDE openFDA FDA Class II

Accessories, Blood Circuit, Hemodialysis

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).

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FDA MAUDE casebook

openFDA event book Accessories, Blood Circuit, Hemodialysis LIGHT-BOOK · MAUDE

#619 of 1000 · 1,220 reports · 1994–2026

  • BOOK 1,220 reports
  • RANK #619 of 1000
  • DEATH 17 death-typed
  • INJ 102 injury-typed
  • MALF 1,085 malfunction
  • SPAN 1994–2026
  • PEAK 2015: 555
  • PHOTO Cardiovascular Proced…

Nearest event-volume peer: Cardiovascular Procedure Kit (1 report gap)

Accessories, Blood Circuit, Hemodialysis sits #619 of 1000 among tracked device types with 1,220 MAUDE reports spanning 1994–2026. 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 →

Malfunction reports run above the device-type norm

Accessories, Blood Circuit, Hemodialysis carries 88.9% MALFUNCTION-coded reports, 24.1pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 1.4% corpus 1.5% · near corpus mean (-0.1 pp)
  • INJ 8.4% corpus 30.3% · below corpus mean (-21.9 pp)
  • MALF 88.9% corpus 64.8% · above corpus mean (+24.1 pp)

Lead product-problem code Fluid/Blood Leak is 71% of coded problems · Lead manufacturer FRESENIUS MEDICAL CARE NORTH AMERICA accounts for 70% of manufacturer-tagged reports · Top event location is 53% of location-tagged rows .

Accessories, Blood Circuit, Hemodialysis in the event-volume neighbourhood

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

reports

What this shows Accessories, Blood Circuit, Hemodialysis carries 1,220 MAUDE reports, ranked #619 of 1000.

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

Event Types

Malfunction 1,085 (88.9%)
Injury 102 (8.4%)
Death 17 (1.4%)
Other 13 (1.1%)
3 (0.2%)

Patient Outcomes

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

1,029 (81.5%)
Required Intervention 87 (6.9%)
Other 50 (4.0%)
Hospitalization 33 (2.6%)
R 26 (2.1%)
Death 15 (1.2%)
L 10 (0.8%)
O 4 (0.3%)
D 2 (0.2%)
H 2 (0.2%)
Life Threatening 2 (0.2%)
S 1 (0.1%)
Disability 1 (0.1%)

Top Product Problems

Fluid/Blood Leak 889
Leak/Splash 54
Disconnection 50
Adverse Event Without Identified Device or Use Problem 39
Material Separation 32
Thermal Decomposition of Device 28
Crack 22
Explanted 18
Replace 17
Smoking 16
Nonstandard Device 13
Hole In Material 12
Tears, rips, holes in device, device material 12
Air Leak 11
Fire 8
Loose or Intermittent Connection 8
Difficult to Remove 7
Overheating of Device 7
Patient Device Interaction Problem 7
Detachment Of Device Component 6

Yearly Trend

94
1994: 17
95
1995: 1
96
1996: 4
98
1998: 10
99
1999: 7
00
2000: 29
01
2001: 18
02
2002: 12
03
2003: 6
04
2004: 9
05
2005: 5
06
2006: 3
07
2007: 3
08
2008: 12
09
2009: 12
10
2010: 4
11
2011: 10
12
2012: 2
13
2013: 22
14
2014: 165
15
2015: 555
16
2016: 10
17
2017: 23
18
2018: 37
19
2019: 56
20
2020: 20
21
2021: 33
22
2022: 26
23
2023: 16
24
2024: 18
25
2025: 50
26
2026: 25

Reports rose to 50 in 2025, up from an average of 17 in the two years before - a recent-year increase, not a lifetime pattern.

Related Entities for Accessories, Blood Circuit, Hemodialysis

Top Manufacturers

FRESENIUS MEDICAL CARE NORTH AMERICA 613
ERIKA DE REYNOSA, S.A. DE C.V. 204
CONCORD MANUFACTURING 57

Event Locations

645 (52.9%)
NO INFORMATION 302 (24.8%)
I 163 (13.4%)
HOSPITAL 45 (3.7%)
OTHER 30 (2.5%)
OUTPATIENT TREATMENT FACILITY 26 (2.1%)
HOME 4 (0.3%)
INVALID DATA 3 (0.2%)
DIALYSIS UNIT 2 (0.2%)

Compare FRESENIUS MEDICAL CARE NORTH AMERICA vs ERIKA DE REYNOSA, S.A. DE C.V. →

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Accessories, Blood Circuit, 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 (1,220 here).

Cardiovascular Procedure Kit 1,221 Hemodialyzer, Re-Use, High Flux 1,219 System, X-Ray, Stationary 1,218 System/Device, Pharmacy Compounding 1,226

Similar death-typed counts

Nearest other device types by death-typed report count (17 here), distinct from the volume row.

Cable, Transducer And Electrode, Patient, 17 Counter, Differential Cell 17 Forceps, Biopsy, Non-Electric 17 Incubator, Neonatal 17

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

Disclaimer: MAUDE figures for Accessories, Blood Circuit, 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 Accessories, Blood Circuit, 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.