ABVISER-INTRA ABDOMINAL PRESSURE MONITOR
Received Oct 14, 2014 · Event occurred Sep 17, 2014
Report 1049092-2014-00517 · MDR key 4181171
Device
Generic name
Device, Cystometric, Hydraulic
Manufacturer
Convatec, Inc.Model number
ABV321Catalog number
ABV321
Lot number
130217
Product problems
- Deflation Problem
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
IT IS REPORTED THAT AFTER NINE (9) DAYS OF PLACEMENT OF THE DEVICE ON A PT FROM THE ICU, INSUFFLATION WITH 20CC OF SALINE SOLUTION WAS PERFORMED. ALTHOUGH THE MEASURE OF THE INTRA-ABDOMINAL PRESSURE WAS TAKEN CORRECTLY, THE AUTOMATIC VALVE DID NOT COLLAPSE.
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. THE PHYSICIAN WAITED FOR SOME MINUTES AND DECIDED TO REMOVE THE DEVICE SINCE THE PT WAS NOT IN A CRITICAL STATE. THE DEVICE WAS DISCARDED AND UPON REVISION THE DAY AFTER, THE VALVE WAS STILL DISTENDED. AN INVESTIGATION WAS PERFORMED BY THE THIRD PARTY MANUFACTURING SITE THAT INCLUDED A HISTORICAL REVIEW OF THE BATCH RECORDS FOR THE PAST SIX MONTHS TO DATE OF MANUFACTURE OF THE COMPLAINT LOT. ALL THE TESTINGS MET SPECIFICATION AND PERFORMANCE REQUIREMENTS. NO ROOT CAUSE WAS DETERMINED SINCE THE DEVICE HAD BEEN DISCARDED. NO ADD'L PT/EVENT DETAILS HAVE BEEN PROVIDED TO DATE. A RETURN SAMPLE FOR EVAL IS NOT EXPECTED. SHOULD ADD'L INFO BECOME AVAILABLE, A F/U REPORT WILL BE SUBMITTED.