InjuryQJZ

FRESENIUS MEDICAL NOVA LUNG ECMO PUMP PRESSURE CABLE

Received Mar 27, 2026 · Event occurred Mar 24, 2026

Report MW5186036 · MDR key 24708591

Device

Generic name

Extracorporeal System For Long-term Respiratory / Cardiopulmonary Failure

Manufacturer

Fresenius Medical/ Xenios Ag.

Lot number

FSXI0401

Product problems

Incorrect, Inadequate or Imprecise Result or Readings
Defective Device

Patient

NA · Unknown

No Clinical Signs, Symptoms or Conditions

Narrative

Description of Event or Problem

ISSUE WITH THE PRESSURE CABLES ON THE NOVALUNG ECMO MACHINE BY FRESENIUS MEDICAL. WE HAVE HAD AN ADDITIONAL 3 CABLES FAIL IN THE LAST MONTH. THE MOST RECENT BEING LAST NIGHT. NOT ONLY IS THE PRODUCT FAILING BUT READING VERY INCORRECT VALUES, POTENTIALLY LEADING TO INCORRECT TREATMENT OF THE PATIENT. THIS IS RELATED TO PART NUMBER 3835001. LOT NUMBERS: FSXF2421, GSXA2422, FSXI0401. PT CODE: 4582. DPC: 1535, 2588. REFERENCE REPORT: MW5186037, MW5186038.