UNOMETER SAFETI PLUS WITH LUER-LOCK AND LUER
Received Jun 29, 2015 · Event occurred Jun 26, 2015
Report 3007966929-2015-00057 · MDR key 4877708
Device
Product problems
- Defective Component
- Device Operates Differently Than Expected
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
ADDITIONAL INFORMATION WAS RECEIVED 06/29/2015. THE LOT NUMBER AND PRODUCT EVALUATION SAMPLE ARE NOT AVAILABLE. A DETAILED INVESTIGATION OR BATCH REVIEW CANNOT BE CONDUCTED. THEREFORE THIS EVALUATION WILL BE CLOSED AND WILL BE MONITORED THROUGH OUR POST MARKET PRODUCT MONITORING REVIEW PROCESS. NO ADDITIONAL PATIENT/EVENT DETAILS HAVE BEEN PROVIDED TO DATE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE A FOLLOW-UP REPORT WILL BE SUBMITTED.
Description of Event or Problem
THE NURSE REPORTS THE UNOMETER SAFETI PLUS WAS IN PLACE APPROXIMATELY THIRTY MINUTES WHEN THE INTENSIVE CARE UNIT PATIENT RECEIVED INTRAVENOUS DIURETICS BECAUSE URINE WAS NOT BEING PRODUCED. THE NURSE FURTHER REPORTS THE PROBLEM WAS FOUND TO BE A DEFECTIVE OPEN/CLOSE LEVER ON THE URINE MEASUREMENT CHAMBER WHICH CAUSED URINE TO FLOW THROUGH THE MEASUREMENT CHAMBER DIRECTLY INTO THE COLLECTION BAG. IT IS ALSO REPORTED THE DEFECTIVE DEVICE WAS REMOVED AND A NEW DEVICE WAS PLACED. THE NURSE ALSO REPORTS THE PATIENT DID NOT EXPERIENCE INJURY OR HARM.
Additional Manufacturer Narrative
BASED ON THE AVAILABLE INFORMATION, THIS EVENT IS DEEMED A REPORTABLE MALFUNCTION. NO FURTHER INFORMATION WAS AVAILABLE AT THE TIME OF THE REPORT. THERE WERE NO REPORTS OF THE PATIENT BEING HARMED AS A RESULT OF THIS MALFUNCTION. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.