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2026 data FDA MAUDE openFDA FDA Class III

Normothermic Machine Perfusion System For The Preservation Of Donor Livers Prior To Transplantation

Adverse-event figures are drawn from the U.S. Food & Drug Administration (FDA) MAUDE database, refreshed March 2026, see our methodology.

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FDA MAUDE casebook

openFDA event book Normothermic Machine Perfusion System For T… LIGHT-BOOK · MAUDE

#892 of 1000 · 498 reports · 2024–2026

  • BOOK 498 reports
  • RANK #892 of 1000
  • DEATH 2 death-typed
  • INJ 119 injury-typed
  • MALF 377 malfunction
  • SPAN 2024–2026
  • PEAK 2026: 191
  • PHOTO Prosthesis

Nearest event-volume peer: Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous Cemented, Osteophilic Finish (1 report gap)

Normothermic Machine Perfusion System For The Preservation Of Donor Livers Prior To Transplantation sits #892 of 1000 among tracked device types with 498 MAUDE reports spanning 2024–2026. 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

Normothermic Machine Perfusion System For T… carries 75.7% MALFUNCTION-coded reports, 10.9pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 0.4% corpus 1.5% · below corpus mean (-1.1 pp)
  • INJ 23.9% corpus 30.3% · below corpus mean (-6.4 pp)
  • MALF 75.7% corpus 64.8% · above corpus mean (+10.9 pp)

Lead product-problem code Physical Resistance/Sticking is 16% of coded problems · Top event location is 95% of location-tagged rows .

Normothermic Machine Perfusion System For T… in the event-volume neighbourhood

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

reports

What this shows Normothermic Machine Perfusion System For The Preservation Of Donor Livers Prior To Transplantation carries 498 MAUDE reports, ranked #892 of 1000.

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

Event Types

Malfunction 377 (75.7%)
Injury 119 (23.9%)
Death 2 (0.4%)

Patient Outcomes

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

352 (72.9%)
Other 102 (21.1%)
Required Intervention 21 (4.3%)
D 2 (0.4%)
H 2 (0.4%)
L 1 (0.2%)
O 1 (0.2%)
Death 1 (0.2%)
Hospitalization 1 (0.2%)

Top Product Problems

Physical Resistance/Sticking 60
Restricted Flow rate 42
Insufficient Flow or Under Infusion 39
No Flow 36
Insufficient Device Problem Information 22
Loose or Intermittent Connection 17
Premature Discharge of Battery 16
Failure to Pump 15
Incorrect Measurement 15
Pumping Problem 14
Inaccurate Flow Rate 13
Material Twisted/Bent 13
Fluid/Blood Leak 12
Pumping Stopped 12
Adverse Event Without Identified Device or Use Problem 11
Pressure Problem 11
Complete Blockage 10
Failure to Charge 10
Infusion or Flow Problem 10
Charging Problem 9

Yearly Trend

24
2024: 139
25
2025: 168
26
2026: 191

Related Entities for Normothermic Machine Perfusion System For The Preservation Of Donor Livers Prior To Transplantation

Event Locations

472 (94.8%)
HOSPITAL 26 (5.2%)

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Normothermic Machine Perfusion System For T…: 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 (498 here).

Prosthesis 499 Prosthesis 497 Radioimmunoassay, Vancomycin 497 Bronchial Thermoplasty System 500

Similar death-typed counts

Nearest other device types by death-typed report count (2 here), distinct from the volume row.

Accessories, Catheter, G-U 2 Accessories, Soft Lens Products 2 Bed, Pediatric Open Hospital 2 Blade 2

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

Disclaimer: MAUDE figures for Normothermic Machine Perfusion System For T… 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 Normothermic Machine Perfusion System For T…; 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.