RLV-2100 VACUUM RELIEF VALVE
Received Dec 10, 2019
Report 1649914-2019-00069 · MDR key 9447300
Device
Generic name
Cardiopulmonary Suction Control Device
Manufacturer
Quest Medical, IncModel number
4103202Catalog number
4103202
Lot number
056185/056294/056390
Product problems
- Fluid/Blood Leak
- Fluid/Blood Leak
Patient
Not reported
- No Consequences Or Impact To Patient
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
THIS COMPLAINT IS SIMILAR TO RECENT COMPLAINTS RECENTLY RECEIVED ON THIS PART NUMBER. THE DEVICE IS SOLD OUS TO OEM MANUFACTURERS. THE ROOT CAUSE OF THE ISSUE IS OPERATOR ERROR DURING ASSEMBLY OF THE UMBRELLA VALVE. QUEST HAS UPDATED ITS STANDARD OF WORK AND HAS ISSUED A QUALITY ALERT TO TRAIN OPERATORS AND PROVIDE THEM WITH BETTER VISIBILITY OF DEFECTS ASSOCIATED WITH THE UMBRELLA VALVE. IN ADDITION, THE MANUFACTURING LEAK TESTER WILL BE UPDATED TO ENSURE PARTS WITH THIS TYPE OF DEFECT ARE REJECTED.
Description of Event or Problem
THE REPORT RECEIVED STATES THAT THE DEVICE LEAKED DURING A PROCEDURE.