FDA Adverse Event
Summary report: N
TERUMO ROCSAFE FLEXIBLE RESERVOIR
MDR report key: 2243978
·
Received August 22, 2011
Report
- Report Number
- 1124841-2011-00357
- Date Received
- August 22, 2011
- Date of Event
- August 2, 2011
- Report Date
- August 3, 2011
- Manufacturer
- TERUMO CARDIOVASCULAR SYSTEMS CORP.
- Product Code
- KFM
- PMA / PMN Number
- EXEMPT
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KY, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
TERUMO HAS RECEIVED THE ACTUAL DEVICE FOR EVALUATION; HOWEVER, THE INVESTIGATION HAS NOT BEEN COMPLETED. TERUMO WILL BE SUBMITTING A FOLLOW-UP REPORT WHEN MORE INFO BECOMES AVAILABLE. (B)(4).
Description of Event or Problem · 1
THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR SYSTEMS THAT THEY RECEIVED AN EXPIRED ROCSAFE FLEXIBLE RESERVOIR. THERE WAS NO PT INVOLVEMENT AS THIS OCCURRED OUT OF BOX. THERE WAS NO DELAY IN BEGINNING OF SURGICAL PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TERUMO ROCSAFE FLEXIBLE RESERVOIR | CARDIOVASCULAR PROCEDURE KIT | KFM | TERUMO CARDIOVASCULAR SYSTEMS CORP. | NA | MK09 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |