SMITHS MEDICAL LEVEL 1 HOTLINE DISPOSABLE
Received Jan 28, 2020 · Event occurred Dec 19, 2019
Report 3012307300-2020-00815 · MDR key 9639555
Device
Product problems
- Accessory Incompatible
- Accessory Incompatible
Patient
Not reported
- No Consequences Or Impact To Patient
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
OTHER, OTHER TEXT: DEVICE EVALUATION: PICTURE OF LEVEL 1 HOTLINE LOW FLOW SYSTEM WAS RETURNED FOR ANALYSIS. INVESTIGATION PERFORMED AND NO DISCREPANCIES COULD BE OBSERVED IN THE PICTURES. THE CUSTOMER REPORTED PROBLEM COULD NOT BE CONFIRMED. NO ROOT CAUSE HAS TO BE CONFIRMED SINCE THE COMPLAINT WAS NOT CONFIRMED. NO CORRECTIVE ACTIONS ARE REQUIRED SINCE THE COMPLAINT WAS NOT CONFIRMED.
Description of Event or Problem
INFORMATION WAS RECEIVED THAT A SMITHS MEDICAL LEVEL 1 HOTLINE LOW FLOW SYSTEM TUBING SET NOT BEING ACCEPTED BY FLUID WARMER. INCIDENT WAS REPORTED TO HAVE OCCURRED WHILE IN USE WITH A PATIENT, AND THAT NO INJURY OCCURRED.