FLOW COUPLER
Received Jun 7, 2021 · Event occurred May 11, 2021
Report 1416980-2021-03431 · MDR key 11952555
Device
Generic name
Flowmeter, Blood, Cardiovascular
Manufacturer
Baxter Healthcare CorporationModel number
NACatalog number
515101300010
Lot number
SP20L17-1495740
Product problems
- Fitting Problem
- Difficult to Open or Close
- Fitting Problem
- Difficult to Open or Close
Patient
Not reported
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
CORRECTION: B4/F8: DATE OF THIS REPORT IN THE INITIAL MDR IS BEING CORRECTED FROM BLANK TO 06/07/2021.
Additional Manufacturer Narrative
H10: THE DEVICE WAS RECEIVED FOR EVALUATION. A VISUAL INSPECTION WAS PERFORMED, AND IT WAS NOTED THAT TWO PINS ON THE RIGHT RING OF THE JAW ASSEMBLY WERE BENT TO VARYING DEGREES. THIS CONDITION OF THE PINS WOULD NOT ALLOW FOR THE FLOW COUPLER RINGS TO ALIGN AS INTENDED; THIS WOULD LEAD TO THE TWO RINGS OF THE JAW ASSEMBLY TO NOT CLOSING PROPERLY. THE REPORTED CONDITION WAS VERIFIED. THE CAUSE OF THE REPORTED CONDITION 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 THAT THE PINS OF A 3.0MM FLOW COUPLER WOULD NOT ALIGN. IT WAS FURTHER REPORTED THE PINS WERE OFFSET AND THE COUPLER WOULD NOT CLOSE. THIS ISSUE WAS IDENTIFIED DURING PATIENT USE. THE DEVICE WAS REPLACED WITH NO FURTHER ISSUES. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.