NOVALUNG CONSOLE (LINUX BOARD)
Received Jun 17, 2025 · Event occurred Jun 4, 2025
Report 3012172416-2025-00053 · MDR key 22223280
Device
Generic name
Extracorporeal System For Long-term Respiratory / Cardiopulmonary Failure
Manufacturer
Xenios AgCatalog number
F30000163
Product problems
- Device Alarm System
- Communication or Transmission Problem
- Protective Measures Problem
- Device Alarm System
- Communication or Transmission Problem
- Protective Measures Problem
Patient
NA · Unknown
- No Consequences Or Impact To Patient
- No Clinical Signs, Symptoms or Conditions
- No Consequences Or Impact To Patient
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
A USER FACILITY REPORTED THAT WHILE ASSISTING WITH A SIMULATION LABORATORY AT UMC - LUBBOCK, ONE OF THE NURSES WAS SIMULATING A PUMP DRIVE FAILURE. THE PUMP DRIVE THAT WAS IN THE BACKUP POSITION WHEN PLACED IN THE SENSOR BOX WHEN A TECHNICAL FAILURE WAS NOTED. THIS NURSE WAS THE THIRD OR FOURTH TO DO THIS AND THE DEVICE WAS WORKING WELL PREVIOUSLY. THERE WAS NO PATIENT INVOLVEMENT. IT WAS UNKNOWN WHETHER ANY COMPONENT OF THE DEVICE WAS AVAILABLE FOR PRODUCT EVALUATION.
Additional Manufacturer Narrative
THE PLANT INVESTIGATION IS IN PROCESS. A SUPPLEMENTAL MDR WILL BE SUBMITTED UPON COMPLETION OF THIS ACTIVITY.
Additional Manufacturer Narrative
ADDITIONAL INFORMATION: B5, D3, D4, G1, H4, H6. PLANT INVESTIGATION: NON-CONFORMITY WAS NOT OBSERVED DURING THE MANUFACTURING PROCESS. NO OTHER COMPLAINT HAS BEEN REPORTED ABOUT THIS CONSOLE OR THE PUMP DRIVE INVOLVED. THE EVENT MAY REPRESENT A SECONDARY FAULT BECAUSE THE POWER SUPPLY IS PROVIDING TOO LITTLE VOLTAGE, WHICH WOULD TRIGGER FURTHER ALARMS. THE PUMP DRIVE WAS NOT RETURNED FOR EVALUATION. ALARM 109 INDICATES THAT THE VOLTAGE AT THE PUMP DRIVE IS TOO LOW (<9V). THERE WAS PROBABLY A DEFECT IN THE PUMP DRIVE. THE DEVICE HAS BEEN SERVICED ONSITE, AND THE POWER CORD OF THE PUMP DRIVE HAS BEEN REPLACED TO ADDRESS THE ISSUE. THE EXACT DEFECT IS UNKNOWN, AND NO FURTHER INVESTIGATION COULD BE CARRIED OUT. A DEFINITE CAUSE COULD NOT BE DETERMINED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THE RECORD WILL BE UPDATED ACCORDINGLY.
Description of Event or Problem
A USER FACILITY REPORTED THAT WHILE ASSISTING WITH A SIMULATION LABORATORY AT (B)(6), ONE OF THE NURSES WAS SIMULATING A PUMP DRIVE FAILURE. THE PUMP DRIVE THAT WAS IN THE BACKUP POSITION WHEN PLACED IN THE SENSOR BOX WHEN A TECHNICAL FAILURE WAS NOTED. THIS NURSE WAS THE THIRD OR FOURTH TO DO THIS AND THE DEVICE WAS WORKING WELL PREVIOUSLY. THERE WAS NO PATIENT INVOLVEMENT. NO COMPONENTS OF THE NOVALUNG CONSOLE WERE AVAILABLE FOR AVAILABLE FOR PRODUCT INVESTIGATION.