SARNS 8000 PERFUSION SYSTEM
Received Nov 2, 2020
Report 1828100-2020-00419 · MDR key 10774936
Device
Generic name
Monitor And/or Control, Level Sensing, Cardiopulmonary Bypass-sarns 8000
Manufacturer
Terumo Cardiovascular Systems CorporationModel number
16404Catalog number
16404
Product problems
- Device Sensing Problem
- Device Sensing Problem
Patient
Not reported
- 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
Additional Manufacturer Narrative
DURING LABORATORY ANALYSIS, THE PRODUCT SURVEILLANCE TECHNICIAN (PST) COULD NOT VERIFY THE REPORTED ISSUE. THE SAFETY MONITOR WAS OBSERVED TO PERFORM NORMALLY WHEN POWERED ON AND OFF SEVERAL TIMES.
Additional Manufacturer Narrative
THE REPORTED COMPLAINT WAS NOT CONFIRMED. THE SERVICE REPAIR TECHNICIAN COULD NOT DUPLICATE THE ISSUE. THE SAFETY MONITOR WAS OBSERVED TO FUNCTION PROPERLY. THE UNIT OPERATED TO THE MANUFACTURER'S SPECIFICATIONS. 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 USER FACILITY EQUIPMENT SYSTEM, THE UNIT WAS RETIRED IN OCTOBER 2019. THE SAFETY MONITOR IS ON A BACKUP HEART LUNG MACHINE (HLM) WHICH HAS BEEN IN STORAGE SINCE OCTOBER 2019. EVALUATION IS IN PROGRESS, BUT NOT YET CONCLUDED
Description of Event or Problem
IT WAS REPORTED THAT THE SAFETY MONITOR LEVEL DETECTION SYSTEM WOULD NOT TURN ON. THERE WAS NO DELAY, NO BLOOD LOSS, NOR ADVERSE CONSEQUENCES TO THE PATIENT. NO OTHER DETAILS REGARDING THE NATURE OF THIS EVENT WERE PROVIDED.