PlainHospital
2026 data FDA MAUDE openFDA

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.

Browse devices → Device safety hub

FDA MAUDE casebook

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

#605 of 1000 · 1,203 reports · 1994–2026

  • BOOK 1,203 reports
  • RANK #605 of 1000
  • DEATH 17 death-typed
  • INJ 102 injury-typed
  • MALF 1,068 malfunction
  • SPAN 1994–2026
  • PEAK 2015: 555
  • PHOTO Tube, Feeding

Nearest event-volume peer: Tube, Feeding (0 report gap)

Accessories, Blood Circuit, Hemodialysis sits #605 of 1000 among tracked device types with 1,203 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 →

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 1.4% corpus 1.5% · near corpus mean (-0.1 pp)
  • INJ 8.5% corpus 30.4% · below corpus mean (-22.0 pp)
  • MALF 88.8% corpus 64.5% · above corpus mean (+24.3 pp)

Lead product-problem code Fluid/Blood Leak is 58% of coded problems · Lead manufacturer FRESENIUS MEDICAL CARE NORTH AMERICA accounts for 71% of manufacturer-tagged reports · Top event location is 52% 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 1,203 MAUDE reports, ranked #605 of 1000.

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

Event Types

Malfunction 1,068 (88.8%)
Injury 102 (8.5%)
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.

1,013 (81.3%)
Required Intervention 87 (7.0%)
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 188
Thermal Decomposition of Device 27
Adverse Event Without Identified Device or Use Problem 25
Smoking 16
Nonstandard Device 13
Fire 8
Overheating of Device 7
Patient Device Interaction Problem 7
Leak/Splash 6
Disconnection 5
Detachment of Device or Device Component 3
Device Emits Odor 3
Melted 3
Break 2
Component Missing 2
Connection Problem 2
Detachment Of Device Component 2
Device Displays Incorrect Message 2
Inadequate Ultra Filtration 2
Insufficient Heating 2

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: 8

Related Entities for Accessories, Blood Circuit, Hemodialysis

Top Manufacturers

FRESENIUS MEDICAL CARE NORTH AMERICA 613
ERIKA DE REYNOSA, S.A. DE C.V. 192
CONCORD MANUFACTURING 57

Event Locations

628 (52.2%)
NO INFORMATION 302 (25.1%)
I 163 (13.5%)
HOSPITAL 45 (3.7%)
OTHER 30 (2.5%)
OUTPATIENT TREATMENT FACILITY 26 (2.2%)
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 similar MAUDE profiles

Two openFDA-derived peer sets for Accessories, Blood Circuit, 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 (1,203 here).

Tube, Feeding 1,203 System/Device, Pharmacy Compounding 1,201 Lamp, Surgical 1,207 Tube, Gastro-Enterostomy 1,198

Similar death-typed counts

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

Agent, Occluding, Vascular, Permanent 17 Cable, Transducer And Electrode, Patient, 17 Cardiovascular Procedure Kit 17 Counter, Differential Cell 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.