SARNS 8000 PERFUSION SYSTEM
Received Oct 29, 2021
Report 1828100-2021-00391 · MDR key 12719085
Device
Generic name
Monitor And/or Control, Level Sensing, Cardiopulmonary Bypass-sarns 8000
Manufacturer
Terumo Cardiovascular Systems CorporationModel number
16404Catalog number
16404
Product problems
- Output Problem
- Output Problem
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE REPORTED COMPLAINT WAS NOT VERIFIABLE SINCE THE PRODUCT WAS NOT RETURNED FOR EVALUATION OR TESTING. MULTIPLE DILIGENCE ATTEMPTS FOR PART RETURN WERE UNSUCCESSFUL. IF ADDITIONAL INFORMATION BECOMES AVAILABLE ON THIS COMPLAINT THAT WOULD ALTER THE FACTS AND/OR CONCLUSION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY.
Additional Manufacturer Narrative
PER THE USER FACILITY'S BIOMEDICAL ENGINEER, THE REPORTED ISSUE WAS FOUND DURING UNIT CHECK-UP AS THE EQUIPMENT HAD NOT BEEN USED IN SOME TIME.
Description of Event or Problem
IT WAS REPORTED THAT DURING USE OF THE DEVICE FOR A NON-CLINICAL ACTIVITY, THE HEART LUNG MACHINE (HLM) SAFETY MONITOR WAS NOT WORKING. THERE WAS NO PATIENT INVOLVEMENT.