UNOMETER SAFETI PLUS - WITH LUER-LOCK & LUER
Received Feb 26, 2015 · Event occurred Jan 26, 2015
Report 3007966929-2015-00030 · MDR key 4563777
Device
Product problems
- Defective Component
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
BASED ON THE AVAILABLE INFO, THIS EVENT IS DEEMED A REPORTABLE MALFUNCTION. THERE WERE NO REPORTS OF THE PT BEING HARMED AS A RESULT OF THIS MALFUNCTION. ADDITIONAL PT AND EVENT DETAILS HAVE BEEN REQUESTED. SHOULD ADDITIONAL INFO BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. (B)(4).
Description of Event or Problem
IT WAS REPORTED THAT THE PT HAD AN URINOMETER PLACED WHILE UNDERGOING SURGERY. INITIALLY, THE PT HAD 'VERY LOW' DIURESIS. TWO BOTTLES OF ALBUMIN 20% AND FIVE MILLIGRAMS OF FUROSEMIDUM WERE ADMINISTERED TO THE PT WITH NO RESULT. THE HOSP STAFF THEN INSPECTED THE URINOMETER AND FOUND THE INSERT TO THE CHAMBER WAS LOOSE AND HAD STOPPED THE FLOW OF URINE. NO FURTHER INFO WAS PROVIDED.