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2026 data FDA MAUDE openFDA

System, Photopheresis, Extracorporeal

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 System, Photopheresis, Extracorporeal LIGHT-BOOK · MAUDE

#403 of 1000 · 2,915 reports · 1997–2026

  • BOOK 2,915 reports
  • RANK #403 of 1000
  • DEATH 37 death-typed
  • INJ 313 injury-typed
  • MALF 2,518 malfunction
  • SPAN 1997–2026
  • PEAK 2014: 377
  • PHOTO Assay

Nearest event-volume peer: Assay, Glycosylated Hemoglobin (4 report gap)

System, Photopheresis, Extracorporeal sits #403 of 1000 among tracked device types with 2,915 MAUDE reports spanning 1997–2026. 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 → · 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 1.3% corpus 1.5% · near corpus mean (-0.3 pp)
  • INJ 10.7% corpus 30.4% · below corpus mean (-19.7 pp)
  • MALF 86.4% corpus 64.5% · above corpus mean (+21.9 pp)

Lead product-problem code Fluid/Blood Leak is 37% of coded problems · Top event location is 49% of location-tagged rows .

System, Photopheresis, Extracorporeal in the event-volume neighbourhood

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

reports

What this shows System, Photopheresis, Extracorporeal carries 2,915 MAUDE reports, ranked #403 of 1000.

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

Event Types

Malfunction 2,518 (86.4%)
Injury 313 (10.7%)
Death 37 (1.3%)
Other 36 (1.2%)
11 (0.4%)

Patient Outcomes

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

2,465 (81.4%)
Required Intervention 222 (7.3%)
Hospitalization 103 (3.4%)
R 71 (2.3%)
Other 70 (2.3%)
Death 36 (1.2%)
O 16 (0.5%)
Life Threatening 15 (0.5%)
H 12 (0.4%)
L 12 (0.4%)
S 2 (0.1%)
Congenital Anomaly 2 (0.1%)
D 1 (0.0%)

Top Product Problems

Fluid/Blood Leak 875
Leak/Splash 401
Device Displays Incorrect Message 311
Break 304
Adverse Event Without Identified Device or Use Problem 128
Device Alarm System 49
Coagulation in Device or Device Ingredient 47
Noise, Audible 33
Detachment Of Device Component 27
Air Leak 23
Crack 23
Device Operates Differently Than Expected 20
Occlusion Within Device 19
Detachment of Device or Device Component 18
Protective Measures Problem 16
Device Contamination with Body Fluid 15
Device Dislodged or Dislocated 14
Disconnection 14
Use of Device Problem 13
Hole In Material 12

Yearly Trend

97
1997: 1
00
2000: 2
02
2002: 2
03
2003: 2
04
2004: 3
05
2005: 7
06
2006: 25
07
2007: 15
08
2008: 8
09
2009: 12
10
2010: 36
11
2011: 94
12
2012: 118
13
2013: 221
14
2014: 377
15
2015: 319
16
2016: 318
17
2017: 261
18
2018: 183
19
2019: 161
20
2020: 141
21
2021: 114
22
2022: 97
23
2023: 83
24
2024: 151
25
2025: 148
26
2026: 16

Related Entities for System, Photopheresis, Extracorporeal

Event Locations

1,417 (48.6%)
I 1,205 (41.3%)
HOSPITAL 208 (7.1%)
NO INFORMATION 60 (2.1%)
OUTPATIENT TREATMENT FACILITY 18 (0.6%)
OTHER 3 (0.1%)
OUTPATIENT DIAGNOSTIC FACILITY 2 (0.1%)
INVALID DATA 1 (0.0%)
UNKNOWN 1 (0.0%)

Nationwide devices with similar MAUDE profiles

Two openFDA-derived peer sets for System, Photopheresis, Extracorporeal, 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 (2,915 here).

Assay, Glycosylated Hemoglobin 2,919 Adaptor, Hygiene 2,907 Syringe, Antistick 2,905 Dilator 2,929

Similar death-typed counts

Nearest other device types by death-typed report count (37 here), distinct from the volume row.

System, Nuclear Magnetic Resonance Imaging 37 Arthroscope 36 Compressor, Air, Portable 36 Dura Substitute 36

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

Disclaimer: MAUDE figures for System, Photopheresis, Extracorporeal 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 System, Photopheresis, Extracorporeal; 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.