ABVISER-INTRA ABDOMINAL PRESSURE MONITOR DEVICE
Received Sep 7, 2016 · Event occurred Jul 28, 2016
Report 1049092-2016-00388 · MDR key 5934615
Device
Product problems
- Connection Problem
- Connection Problem
Patient
Not reported
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
BASED ON THE AVAILABLE INFORMATION, THIS EVENT IS DEEMED TO BE A REPORTABLE MALFUNCTION. BASED ON THE AVAILABLE INFORMATION, NO PATIENT HARM OCCURRED. NO LOT NUMBER IS AVAILABLE. A DETAILED INVESTIGATION OR BATCH REVIEW CANNOT BE CONDUCTED. THEREFORE THIS EVALUATION WILL BE CLOSED. THIS ISSUE WILL BE MONITORED THROUGH THE POST MARKET PRODUCT MONITORING REVIEW PROCESS. FOLLOW UP HAS BEEN REQUESTED, BUT NO ADDITIONAL DETAILS HAVE BEEN PROVIDED TO DATE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. REPORTED TO THE FDA ON: SEPTEMBER 07, 2016 (B)(4).
Description of Event or Problem
COMPLAINT REPORTED THAT, "IN ICU, ONE (1) ADVISER KIT, THE AUTOVALVE DID NOT DISENGAGE AND PROHIBITED URINE FLOW." REPORTER STATED THAT "AS FAR AS SHE IS AWARE THERE WAS NO INJURY TO THE PATIENT." THE ABVISER WAS REMOVED AND DISCONTINUED FROM THE PATIENT AFTER THIS OCCURRED. THE UNIT WAS DISCARDED BY THE ICU. NO FURTHER INFORMATION WAS AVAILABLE.