MalfunctionKRL
BUBBLE TRAP HOLDER
Received Sep 20, 2011 · Event occurred Mar 18, 2011
Report 9681834-2011-00055 · MDR key 2298561
Device
Generic name
Buvvle Trap Holder
Manufacturer
Terumo Cardiovascular Systems, Corp.Model number
1XX*XH041Catalog number
NA
Lot number
UNK
Product problems
- Device Damaged Prior to Use
Patient
UNK
- No Consequences Or Impact To Patient
Narrative
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 INFO BECOMES AVAILABLE. (B)(4).
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 PT INJURY. THE SURGERY WAS COMPLETED SUCCESSFULLY.