D733 MICRO 40 PH. I.S.O. ARTERIAL FILTER
Received Apr 1, 2014 · Event occurred Mar 5, 2014
Report 1718850-2014-00083 · MDR key 3736629
Device
Generic name
Filter, Blood, Cardiopulmonary Bypass, Arterial Line
Manufacturer
Sorin Group ItaliaModel number
NACatalog number
050527
Lot number
1309250120
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 PRIMING OF THE SORIN HL PACK. THE ARTERIAL FILTER, ALONG WITH THE RESPECTIVE SORIN HL PACK, WAS REPLACED PRIOR TO 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). SORIN GROUP RECEIVED A REPORT THAT THE OUTLET PORT OF THE D733 ARTERIAL FILTER BROKE OFF DURING PRIMING OF THE SORIN HL PACK. THE ARTERIAL FILTER, ALONG WITH THE RESPECTIVE SORIN HL PACK, WAS REPLACED PRIOR TO PT INVOLVEMENT. THE INVESTIGATION IS ONGOING. A FOLLOW-UP REPORT WILL BE SENT WHEN THE INVESTIGATION IS COMPLETE.
Remedial action
- Other