ABVISER - INTRA ABDOMINAL PRESSURE MONITOR DEVICE
Received Jan 7, 2015 · Event occurred Dec 11, 2014
Report 1049092-2015-00006 · MDR key 4398087
Device
Product problems
- Infusion or Flow Problem
Patient
84 YR
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
THE INTENSIVE CARE UNIT (ICU) NURSE REPORTED AN ABVISER WAS PLACED ON A PT ON (B)(6) 2014 TO MONITOR POST OPERATIVE ABDOMINAL PRESSURE AFTER GYNECOLOGIC SURGERY OF LYSIS OF ADHESIONS OF A CYST AND NO URINE OUTPUT AFTER THE SURGERY. THE ICU NURSE FURTHER REPORTS WAITING ONE (1) TO THREE (3) MINUTES AFTER SALINE SOLUTION WAS INSTILLED INTO THE ABVISER NOTING THE AUTO-VALVE DID NOT OPEN; THE ABVISER WAS DISCONTINUED AND A NEW ABVISER WAS PLACED ON THE PT. THE ICU NURSE REPORTS THERE WAS NO HARM TO THE PT NOR FURTHER MEDICAL INTERVENTION GIVEN.
Additional Manufacturer Narrative
ADDITIONAL INFORMATION WAS RECEIVED ON AUGUST 26, 2015. THE RETURNED UNIT HAD NO LOT NUMBER THEREFORE THE THIRD PARTY MANUFACTURER PERFORMED A REVIEW OF THE HISTORICAL BATCH RECORDS FOR ABV301 WHICH SHOWED ALL TESTING MET SPECIFICATION. THE RETURNED UNIT WAS EVALUATED AND DID NOT FUNCTION PROPERLY. UNIT WAS EXAMINED UNDER A MICROSCOPE AND IT SHOWED THE VALVE ASSEMBLY WAS CORRECTLY ASSEMBLED BUT THE OPENING WAS COMPLETELY CLOGGED WITH AN UNKNOWN PARTICLE WHICH WAS A SOFT YELLOW AND BROWN MATERIAL. THE EXACT SOURCE OF THE PARTICLE COULD NOT BE DETERMINED DUE TO ITS SMALL SIZE. NO PREVIOUS INVESTIGATIONS ARE AVAILABLE. AFTER A THOROUGH REVIEW OF THE RETURNED PARTICLE AND BATCH REVIEW NO DISCREPANCIES WERE DISCOVERED. THERE IS NOT ENOUGH INFORMATION TO CONCLUDE THE PRODUCT DID NOT MEET SPECIFICATION AND PERFORM AS INTENDED. PRODUCT MONITORING REVIEWS WILL MONITOR FOR PRODUCT TRENDS IF THIS ISSUE WERE TO REOCCUR. NO FURTHER ACTIONS ARE REQUIRED AND THIS COMPLAINT WILL BE CLOSED. NO ADDITIONAL PATIENT/EVENT DETAILS HAVE BEEN PROVIDED TO DATE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE A FOLLOW-UP REPORT WILL BE SUBMITTED. (B)(4).
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/EVENT DETAILS HAVE BEEN REQUESTED. SHOULD ADDITIONAL INFO BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. REPORTED TO THE FDA ON 01/06/2015.