NI
Received Oct 4, 2021 · Event occurred Sep 8, 2021
Report 1416980-2021-06052 · MDR key 12568886
Device
Generic name
Flowmeter, Blood, Cardiovascular
Manufacturer
Baxter Healthcare CorporationModel number
NACatalog number
ASKU
Lot number
ASKU
Product problems
- Device Sensing Problem
- Device Sensing Problem
Patient
Not reported
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE DEVICE WAS NOT RETURNED AND THE LOT NUMBER IS UNKNOWN; THEREFORE, A DEVICE ANALYSIS COULD NOT BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
Description of Event or Problem
IT WAS REPORTED THAT AN UNSPECIFIED FLOW COUPLER DID NOT DETECT COMPROMISED PATENCY. THIS ISSUE WAS IDENTIFIED DURING USE OF THE DEVICE. IT WAS FURTHER REPORTED THE CUSTOMER BELIEVED THE DEVICE WAS "DETECTING A NEAR BY FLOW DUE TO POOR PLACEMENT INTRAOPERATIVELY". THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.