FDA Adverse Event
Summary report: N
CARDIOVASCULAR PROCEDURE KIT
MDR report key: 2031307
·
Received March 16, 2011
Report
- Report Number
- 1124841-2011-00115
- Date Received
- March 16, 2011
- Date of Event
- February 24, 2011
- Report Date
- February 24, 2011
- Manufacturer
- TERUMO CARDIOVASCULAR SYSTEMS CORP.
- Product Code
- DTR
- PMA / PMN Number
- EXEMPT
- Removal / Correction Number
- NA
- Report Source
- Manufacturer report
- Reporter Location
- WV, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
TERUMO HAS NOT RECEIVED THE ACTUAL DEVICE FOR EVALUATION; THEREFORE, THE INVESTIGATION HAS NOT BEEN COMPLETED. TERUMO WILL BE SUBMITTING A FOLLOW-UP REPORT WHEN MORE INFORMATION BECOMES AVAILABLE. (B)(4).
Description of Event or Problem · 1
THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR SYSTEMS THAT PRIOR TO CARDIOPULMONARY BYPASS SURGERY, DURING PRIME, THERE WAS A LEAK IN THE CARDIOPLEGIA LINE. THE PRODUCT WAS CHANGED OUT. THERE WAS NO PATIENT INVOLVEMENT. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CARDIOVASCULAR PROCEDURE KIT | CARDIOVASCULAR PROCEDURE KIT | DTR | TERUMO CARDIOVASCULAR SYSTEMS CORP. | NA | MM18 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |