ABVISER AUTOVALVE VALVE IAP MONITORING DEVICE

Description of Event or Problem

THE NURSE REPORTS A PATIENT IN THE HOSPITAL FOR DIABETIC COMA. IT WAS FURTHER REPORTED THE ABVISER IAP MONITORING DEVICE WAS IN PLACE FOUR DAYS WHEN THE NURSE NOTED THE DEVICE DIDN'T WORK CORRECTLY. THE NURSE STATED THE DEVICE WAS REMOVED AND WHEN CONNECTED TO THE URINE DRAINAGE BAG APPROXIMATELY FOUR HUNDRED MILLILITERS OF URINE WAS OBTAINED; THE NURSE ESTIMATES THE PATIENT HAD NO URINE OUTPUT FOR APPROXIMATELY FOUR HOURS. THE NURSE FURTHER REPORTS THE PATIENT HAD NO COMPLICATIONS BASED ON THIS EVENT AND THE DEVICE WAS DISCONTINUED.

Additional Manufacturer Narrative

BASED ON THE AVAILABLE INFORMATION, THIS EVENT IS DEEMED A REPORTABLE MALFUNCTION. THERE WERE NO REPORTS OF THE PATIENT BEING HARMED AS A RESULT OF THIS MALFUNCTION. ADDITIONAL PATIENT/EVENT DETAILS HAVE BEEN REQUESTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE A FOLLOW-UP REPORT WILL BE SUBMITTED. (B)(6).