NRFIT
Received Jan 15, 2021 · Event occurred Nov 1, 2020
Report 3012307300-2021-00470 · MDR key 11177740
Device
Generic name
Administrations Sets With Neuraxial Connectors
Manufacturer
Smiths Medical Asd, Inc.Model number
21-7609-24Catalog number
21-7609-24
Lot number
4010530
Product problems
- Insufficient Flow or Under Infusion
Patient
Not reported
- No Consequences Or Impact To Patient
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
ONLY THE MONTH ((B)(6)) AND YEAR (2020) OF THE EVENT DATE ARE KNOWN. (B)(6). DEVICE EVALUATION IN PROGRESS.
Description of Event or Problem
IT WAS REPORTED THAT DURING THE USE OF THE CADD CASSETTE RESERVOIR, THE OPERATOR NOTICED AIR BUBBLES IN THE MEDICATION BAG. THE PUMP ALSO PRODUCED AN "AIR IN-LINE DETECTED" ALARM. NO PATIENT INJURY OR COMPLICATIONS WERE REPORTED IN RELATION TO THIS EVENT.
Additional Manufacturer Narrative
OTHER TEXT: THREE PICTURES AND ONE UNIT WERE RETURNED FOR EVALUATION. THE UNIT WAS FILLED, PRIMED, AND CONNECTED WITHOUT DIFFICULTY. THE PUMP WAS SET RUNNING AND ALL ALARMS WERE TESTED. NO FAULT WAS FOUND WITH THE RETURNED DEVICE. THE DEVICE HISTORY RECORD WAS REVIEWED AND SHOWED THAT THIS DEVICE MET ALL MANUFACTURING SPECIFICATION FOR PRODUCT RELEASED FOR DISTRIBUTION. NO ISSUES WERE IDENTIFIED THAT WOULD HAVE IMPACTED THIS EVENT.