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2026 data FDA MAUDE openFDA FDA Class III

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

#411 of 1000 · 2,966 reports · 1997–2026

  • BOOK 2,966 reports
  • RANK #411 of 1000
  • DEATH 37 death-typed
  • INJ 319 injury-typed
  • MALF 2,563 malfunction
  • SPAN 1997–2026
  • PEAK 2014: 377
  • PHOTO Light Source

Nearest event-volume peer: Light Source, Fiberoptic, Routine (7 report gap)

System, Photopheresis, Extracorporeal sits #411 of 1000 among tracked device types with 2,966 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 →

Malfunction reports run above the device-type norm

System, Photopheresis, Extracorporeal carries 86.4% MALFUNCTION-coded reports, 21.6pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 1.2% corpus 1.5% · near corpus mean (-0.3 pp)
  • INJ 10.8% corpus 30.3% · below corpus mean (-19.5 pp)
  • MALF 86.4% corpus 64.8% · above corpus mean (+21.6 pp)

Lead product-problem code Fluid/Blood Leak is 31% 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 2,966 MAUDE reports, ranked #411 of 1000.

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

Event Types

Malfunction 2,563 (86.4%)
Injury 319 (10.8%)
Death 37 (1.2%)
Other 36 (1.2%)
11 (0.4%)

Patient Outcomes

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

2,506 (81.4%)
Required Intervention 225 (7.3%)
Hospitalization 103 (3.3%)
Other 74 (2.4%)
R 71 (2.3%)
Death 36 (1.2%)
O 16 (0.5%)
Life Threatening 16 (0.5%)
H 13 (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 1,281
Leak/Splash 786
Device Displays Incorrect Message 695
Break 427
Adverse Event Without Identified Device or Use Problem 177
Device Alarm System 100
Noise, Audible 97
Air Leak 94
Device Operates Differently Than Expected 74
Device Contamination with Body Fluid 60
Coagulation in Device or Device Ingredient 55
Insufficient Device Problem Information 55
Crack 52
Detachment Of Device Component 51
Occlusion Within Device 48
Hole In Material 30
Improper or Incorrect Procedure or Method 28
Failure to Prime 24
Pressure Problem 24
Alarm, audible 22

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: 120
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: 65

Reports in 2025 (148) held close to the prior two-year average of 117.

Related Entities for System, Photopheresis, Extracorporeal

Event Locations

1,466 (49.4%)
I 1,205 (40.6%)
HOSPITAL 210 (7.1%)
NO INFORMATION 60 (2.0%)
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 a comparable volume-and-death footprint

Two openFDA-derived peer sets for System, Photopheresis, Extracorporeal: 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 (2,966 here).

Light Source, Fiberoptic, Routine 2,959 Medical Device Data System 2,981 Assay, Glycosylated Hemoglobin 2,943 Syringe, Antistick 2,941

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.