ABVISER-INTRA ABDOMINAL PRESSURE MONITOR DEVICE
Received Oct 10, 2013 · Event occurred Sep 26, 2013
Report 2243969-2013-00125 · MDR key 3449273
Device
Generic name
Device, Cystometric, Hydraulic
Manufacturer
Convatec, Inc.Model number
ABV320Catalog number
ABV3320
Lot number
121206
Product problems
- Device Operates Differently Than Expected
Narrative
Description of Event or Problem
IT IS REPORTED THAT THERE WAS A POSSIBLE MALFUNCTION TO THE BLADDER PRESSURE MONITORING DEVICE ON THE ABVISER. IT IS FURTHER REPORTED THAT THE PREDETERMINED AMOUNT OF SALINE INSTILLED INTO THE BALLOON, 20ML, BUT DID NOT PRODUCE AN EQUAL OUTPUT FROM BLADDER. UPON REMOVAL OF DEVICE FROM PT, THE AMOUNT OF FLUID AND/OR SALINE RETURNED FROM BLADDER APPEARED TO BE GREATER THAT 300 ML.
Additional Manufacturer Narrative
BASED ON THE AVAILABLE INFO, THIS EVENT IS DEEMED A REPORTABLE MALFUNCTION. A RECURRENCE IS LIKELY TO LEAD TO A SERIOUS INJURY/SERIOUS ILLNESS. A LACK OF DRAINAGE MAY BE AN INDICATION OF AN OBSTRUCTION TO THE FLOW OF URINE. NO PT WAS HARMED AS A RESULT OF THIS MALFUNCTION. NO ADD'L INFO HAS BEEN PROVIDED TO DATE. A RETURN SAMPLE IS NOT EXPECTED FOR EVAL. SHOULD ADD'L INFO BE RECEIVED, A F/U REPORT WILL BE SUBMITTED.