FDA Adverse Event
Malfunction
Summary report: N
CARDIOVASCULAR PROCEDURE KIT
MDR report key: 1983323
·
Received February 4, 2011
Report
- Report Number
- 1212122-2011-00014
- Event Type
- Malfunction
- Date Received
- February 4, 2011
- Date of Event
- December 28, 2010
- Report Date
- January 11, 2011
- Manufacturer
- TERUMO CARDIOVASCULAR SYSTEMS CORPORATION
- Product Code
- OEZ
- PMA / PMN Number
- EXEMPT
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TN, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
TERUMO DID RECEIVE THE ACTUAL DEVICE; HOWEVER, THE COMPLAINT WAS NOT CONFIRMED. NO LEAKS WERE FOUND DURING PRESSURE TESTING. TERUMO WILL MONITOR FOR FUTURE ISSUES. THE COMPLAINT WILL BE INCLUDED IN ASSOCIATE AWARENESS TRAINING. THE DEVICE HISTORY RECORD DID NOT INDICATE ANY PRODUCTION RELATED PROBLEMS. ALL AVAILABLE INFO HAS BEEN PLACED ON FILE IN QUALITY MANAGEMENT FOR APPROPRIATE TRACKING, TRENDING, AND F/U. (B)(4).
Description of Event or Problem · 1
THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT PRIOR TO CARDIOPULMONARY BYPASS SURGERY, DURING PRIME, THE BUBBLE TRAP FROM THE CARDIOPLEGIA LEAKED. THE PRODUCT WAS CHANGED OUT, THERE WAS NO BLOOD LOSS, AND SURGERY WAS COMPLETED SUCCESSFULLY. THE EVENT DID NOT CAUSE DELAY IN SURGICAL PROCEDURE. THERE WAS NO PT HARM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CARDIOVASCULAR PROCEDURE KIT | CONVENIENCE TUBING PACK | OEZ | TERUMO CARDIOVASCULAR SYSTEMS CORPORATION | MK30T |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |