FLOW COUPLER
Received Mar 10, 2020 · Event occurred Feb 10, 2020
Report 1416980-2020-01304 · MDR key 9811291
Device
Generic name
Flowmeter, Blood, Cardiovascular
Manufacturer
Baxter Healthcare CorporationModel number
NACatalog number
515101300010
Lot number
SP19D12-1366274
Product problems
- Disconnection
- Disconnection
Patient
Not reported
- No Consequences Or Impact To Patient
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
ADDITIONAL INFORMATION WAS ADDED: THE DEVICE WAS RECEIVED FOR EVALUATION. VISUAL INSPECTION WAS PERFORMED WHICH OBSERVED BOTH RINGS SHOWED SIGNS OF USE (DRIED BLOOD, TISSUE). FURTHER INSPECTION OBSERVED THAT THE RETURNED RINGS WERE OUTSIDE OF THE JAW ASSEMBLY, FREE FLOATING INSIDE A SPECIMEN JAR. THE REPORTED CONDITION WAS VERIFIED. THE CAUSE OF THE RING DISLODGEMENT COULD NOT BE DETERMINED. A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
Additional Manufacturer Narrative
SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
Description of Event or Problem
IT WAS REPORTED THE FLOWCOUPLER DISLODGED. THE EVENT WAS FURTHER DESCRIBED AS "THE SURGEON WAS TRYING TO CLOSE THE FLOWCOUPLER, IT CAME OFF OF THE BLACK HOLDER¿. THE EVENT OCCURRED DURING AN UNSPECIFIED MEDICAL PROCEDURE. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.