ABVISER AUTOVALVE IAP MONITORING WITH TRANSDUCER, PATIENT MOUNT
Received Nov 5, 2015
Report 1722554-2015-31255 · MDR key 5203996
Device
Generic name
Device, Cystometric, Hydraulic
Manufacturer
Wolfe Tory Medical IncModel number
ABV320Lot number
10505A
Product problems
- No Flow
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
CONVATEC IS SUBMITTING THIS REPORT AS A RESULT OF ACTIVITIES RELATED TO CONVATEC REMEDIATION PROTOCOL (B)(4). CONVATEC IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21CFR PART 803. 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 THAT URINARY AUTOVALVE DID NOT DRAIN THE SALINE INSTILLED IN PATIENT. THE PATIENT DID NOT HAVE ANY URINE OUTPUT. STAFF BELIEVED THE VALVE TO BE BLOCKED. DISCARDED PRODUCT AND REPLACED WITH ANOTHER. NOT FOR SURE HOW LONG THE VALVE WAS CLOSED. PATIENT DID NOT HAVE ADVERSE EFFECTS ALTHOUGH A FLUID BOLUS WAS GIVEN FOR DECREASED URINE OUTPUT. PATIENT WAS TRANSFERRED TO AN LONG TERM ACUTE CARE FACILITY.