FDA Adverse Event
Summary report: N
BUBBLE TRAP HOLDER
MDR report key: 2417871
·
Received January 11, 2012
Report
- Report Number
- 9681834-2012-00003
- Date Received
- January 11, 2012
- Date of Event
- March 18, 2011
- Report Date
- March 18, 2011
- Manufacturer
- TERUMO CARDIOVASCULAR SYSTEMS CORPORATION
- Product Code
- KRL
- PMA / PMN Number
- NA
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VA, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
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).
Description of Event or Problem · 1
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.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BUBBLE TRAP HOLDER | BUBBLE TRAP HOLDER | KRL | TERUMO CARDIOVASCULAR SYSTEMS CORPORATION | 1XX*XH041 | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |