SENSICA UO MONITOR ICU
Received Apr 7, 2022 · Event occurred Mar 14, 2022
Report 1018233-2022-02089 · MDR key 14043841
Device
Generic name
Sensica Device
Manufacturer
C.r. Bard, Inc. (covington) -1018233Model number
SCCS1002ECatalog number
SCCS1002E
Lot number
NA
Product problems
- Volume Accuracy Problem
- Volume Accuracy Problem
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED.
Description of Event or Problem
IT WAS REPORTED THAT THE SENSICA DEVICE HAD AN ADDITIONAL VOLUME DETECTED ALARM POP UP DURING EDUCATION. THE NURSES DIDN¿T ADD VOLUME, BUT THE MACHINE ADDED 135ML. THEY WERE PLAYING WITH THE MACHINE, SO THEY DIDN¿T REALLY SEE THE VOLUME ADDITION AS AN ISSUE, BUT THEY WERE CONCERNED WITH THE DURATION OF THE ALARM. THEY SWEAR IT WAS LESS THAN 30 SECONDS AS THEY DIDN¿T HAD TIME TO READ OR ADDRESS IT BEFORE IT DISAPPEARED AND ADDED THE VOLUME. USER STATED TO CHECK IF THE ALARM NOT LASTING THE FULL 30 SECONDS WAS AN ISSUE.
Description of Event or Problem
IT WAS REPORTED THAT THE SENSICA DEVICE HAD AN ADDITIONAL VOLUME DETECTED ALARM POP UP DURING EDUCATION. THE NURSES DIDN¿T ADD VOLUME, BUT THE MACHINE ADDED 135ML. THEY WERE PLAYING WITH THE MACHINE, SO THEY DIDN¿T REALLY SEE THE VOLUME ADDITION AS AN ISSUE, BUT THEY WERE CONCERNED WITH THE DURATION OF THE ALARM. THEY SWEAR IT WAS LESS THAN 30 SECONDS AS THEY DIDN¿T HAD TIME TO READ OR ADDRESS IT BEFORE IT DISAPPEARED AND ADDED THE VOLUME. USER STATED TO CHECK IF THE ALARM NOT LASTING THE FULL 30 SECONDS WAS AN ISSUE.
Additional Manufacturer Narrative
THE REPORTED ISSUE WAS UNCONFIRMED. THE ROOT CAUSE OF THE REPORTED ISSUE COULD NOT BE DETERMINED AS THE REPORTED ISSUE COULD NOT BE REPRODUCED. THE DEVICE WAS EVALUATED UPON RECEIPT. THE PROBLEM WAS COULD NOT BE REPRODUCED. IT WAS ALSO REPORTED THAT THE ALARM DID NOT LAST THE FULL 30 SECONDS. AT DEPOT, THIS ISSUE COULD NOT BE REPRODUCED. DEVICE PASSED FINAL FUNCTIONAL TESTING. IT IS UNKNOWN WHETHER THE DEVICE WAS INFLUENCED BY THE REPORTED FAILURE, HOWEVER THE DEVICE MET SPECIFICATIONS. THE DEVICE WAS NOT IN USE ON A PATIENT. AS THE REPORTED EVENT IS UNCONFIRMED THEREFORE THE DHR REVIEW IS NOT REQUIRED. BASED ON THE RESULTS OF THIS INVESTIGATIONS, NO ADDITIONAL ACTION IS REQUIRED AT THIS TIME. AS THE REPORTED EVENT IS UNCONFIRMED THEREFORE THE LABELING/PACKAGING REVIEW IS NOT REQUIRED. THE ACTUAL/SUSPECTED DEVICE WAS INSPECTED.