ABVISER AUTOVALVE IAP MONITORING WITH TRANSDUCER, POLE MOUNT
Received Nov 5, 2015
Report 1722554-2015-31257 · MDR key 5205240
Device
Product problems
- No Flow
Patient
Not reported
- Urinary Retention
Narrative
Additional Manufacturer Narrative
CONVATEC IS SUBMITTING THIS REPORT AS A RESULT OF ACTIVITIES RELATED TO CONVATEC REMEDIATION PROTOCOL (B)(4). ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT WILL BE FILED ON A SUPPLEMENTAL REPORT (MEDWATCH 3500A).
Description of Event or Problem
IT WAS REPORTED URINE RETENTION WITH THE ABVISER. BLADDER PRESSURE COMPLETED AND WITHIN A FEW MINUTES THEY NOTED THE 20ML OF FLUSH IN THE URIMETER. SHE DID NOT SEE ANY URINE IN THE URIMETER OR BAG. THEY DID BLADDER PRESSURES EVERY 6 HOURS FOR APPROXIMATELY 3 DAYS SO APPROXIMATELY 11 INFUSIONS FOR A TOTAL OF 220ML. THEY PERFORMED A BLADDER SCAN AND IT READ 300ML. THEY REMOVED THE ABVISER AUTOVALVE; RECONNECTED THE URIMETER TUBING AND 250ML OF URINE DRAINED OUT. THE FIRST BLADDER PRESSURE WAS PERFORMED AT 10AM AND A CYSTOGRAM PERFORMED AROUND NOON ON THE SAME DAY. TECHNICIAN INSTILLED DYE FOR CYSTOGRAM IN THE FOLEY CATHETER PORT. NURSE REPORTED AUTOVALVE REMAINS INFLATED EVEN AFTER REMOVING IT.