ADVISER AUTOVALVE IAP MONITORING DEVICE WITH E
Received Dec 10, 2014 · Event occurred Nov 11, 2014
Report 1049092-2014-00613 · MDR key 4338159
Device
Product problems
- Partial Blockage
- Deflation Problem
Patient
Not reported
- Urinary Retention
Narrative
Description of Event or Problem
THE CRITICAL CARE EDUCATOR COLLEEN RYAN, REGISTERED NURSE REPORTS THAT THE GREEN VALVE IN THE AUTOVALVE DID NOT DEFLATE WITH ONE UNIT OUT OF A CASE OF 10. THE REGISTERED NURSE CARING FOR THE PATIENT STATES THAT THE PATIENT WAS VOIDING AROUND THE FOLEY CATHETER RATHER THAN THROUGH THE CATHETER. THE REGISTERED NURSE ATTEMPTED TO IRRIGATE THE FOLEY CATHETER AND THEN CHANGED THE FOLEY CATHETER, BUT THE URINE CONTINUED TO DRAIN AROUND THE CATHETER RATHER THAN THROUGH THE CATHETER. THE REGISTERED NURSE REMOVED THE ABVISER AND THE URINE THEN STARTED TO DRAIN.
Additional Manufacturer Narrative
BASED ON THE AVAILABLE INFORMATION, THIS EVENT IS DEEMED A SERIOUS INJURY. NO ADDITIONAL PATIENT/EVENT DETAILS HAVE BEEN PROVIDED TO DATE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.