BUBBLE TRAP HOLDER
Received Jan 11, 2012 · Event occurred Mar 18, 2011
Report 9681834-2012-00003 · MDR key 2417871
Device
Generic name
Bubble Trap Holder
Manufacturer
Terumo Cardiovascular Systems CorporationModel number
1XX*XH041Catalog number
NA
Lot number
UNK
Product problems
- Device Damaged Prior to Use
Patient
UNK
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR SYSTEMS THAT DURING CARDIOPULMONARY BYPASS SURGERY, IT WAS NOTICED THAT THE RING THAT HOLDS THE ARTERIAL FILTER WAS CRACKING. THE PRODUCT WAS NOT CHANGED OUT. THERE WAS NO PATIENT INJURY. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Additional Manufacturer Narrative
TERUMO HAS NOT RECEIVED THE ACTUAL DEVICE FOR INVESTIGATION; THEREFORE, TERUMO IS STILL INVESTIGATING THIS ISSUE, AND A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETED AND MORE INFORMATION BECOMES AVAILABLE. (B)(4).