OtherDTM
D733 MICRO 40 PH.I.S.O. ARTERIAL FILTER
Received Sep 3, 2014 · Event occurred Aug 8, 2014
Report 1718850-2014-00312 · MDR key 4071180
Device
Generic name
Filter, Blood, Cariopulmonary Bypass, Arterial Line
Manufacturer
Sorin Group ItaliaModel number
NACatalog number
050527
Lot number
1401310032
Product problems
- Other (for use when an appropriate device code cannot be identified)
Patient
NA
- No Patient involvement
Narrative
Description of Event or Problem
SORIN GROUP RECEIVED A REPORT THAT THE OUTLET PORT OF THE D733 ARTERIAL FILTER BROKE OFF DURING SET UP. THERE WAS NO PT INVOLVEMENT.
Additional Manufacturer Narrative
SORIN GROUP (B)(4) MANUFACTURES THE D733 MICRO 40 PH.I.S.O. ARTERIAL FILTER. THE INCIDENT OCCURRED IN (B)(6). THIS MEDWATCH IS BEING FILED ON BEHALF OF SORIN GROUP (B)(4). THE INVESTIGATION IS ONGOING. A F/U REPORT WILL BE SENT WHEN THE INVESTIGATION IS COMPLETE.
Remedial action
- Other