MalfunctionKPM
SHUNT DENVER ASCITES DOUBLE VALVE
Received Dec 18, 2017 · Event occurred Nov 30, 2017
Report 1625685-2017-00422 · MDR key 7125715
Device
Product problems
- Occlusion Within Device
Patient
Not reported
- No Consequences Or Impact To Patient
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
(B)(4) INITIAL EMDR SUBMISSION. A FOLLOW UP EMDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE. (B)(4). DEVICE NOT RETURNED, NO LOT NUMBER PROVIDED.
Description of Event or Problem
SYMPTOMATIC PATIENT WITH ASCITES. DENVER SHUNT, INSERTED IN 2017, NOT PUMPING. RADIOLOGIST CONCERNED ABOUT PUMP CHAMBER AND/OR VENOUS CATHETER BEING BLOCKED. ADVISED TO CHECK THAT THE PUMP CHAMBER AND VENOUS CATHETER ARE NOT BLOCKED. REPLACE WITH NEW DENVER SHUNT. DOUBLE-PAK.
Remedial action
- Other