ABVISER-INTRA ABDOMINAL PRESSURE MONITOR DEVICE
Received Oct 10, 2013 · Event occurred Sep 23, 2013
Report 2243969-2013-00124 · MDR key 3449258
Device
Generic name
Device, Cystometric, Hydraulic
Manufacturer
Convatec IncModel number
ABV300Catalog number
ABV300
Lot number
121206
Product problems
- Overfill
- Device Operates Differently Than Expected
Patient
Not reported
- No Known Impact Or Consequence To Patient
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 NS SALINE INSTILLED INTO BLADDER DID NOT RETURN/DRAIN. UPON REMOVAL OF DEVICE FROM FOLEY CATHETER, THE AMOUNT RETURNED APPEARED TO BE GREATER THAN 300 ML FLUID DRAINED FROM BLADDER.
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.