FDA Adverse Event
Malfunction
Summary report: N
TERUMO ROCSAFE FLEXIBLE RESERVOIR
MDR report key: 2220091
·
Received August 9, 2011
Report
- Report Number
- 1124841-2011-00351
- Event Type
- Malfunction
- Date Received
- August 9, 2011
- Date of Event
- July 20, 2011
- Report Date
- July 20, 2011
- Manufacturer
- TERUMO CARDIOVASCULAR SYSTEMS CORP.
- Product Code
- KFM
- PMA / PMN Number
- K082321
- 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 DID RECEIVE THE ACTUAL DEVICE AND VISUAL INSPECTION CONFIRMED THE COMPLAINT, THE PART WAS ASSEMBLED INCORRECTLY INTO THE ROCSAFE KIT. (B)(4). ALL AVAILABLE INFO HAS BEEN PLACED ON FILE IN QUALITY MGMT FOR APPROPRIATE TRACKING, TRENDING AND FOLLOW UP.
Description of Event or Problem · 1
THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR SYSTEMS THAT PRIOR TO CARDIOPULMONARY BYPASS SURGERY, OUT OF BOX, THE FLEXIBLE VENOUS RESERVOIR BAG WAS ASSEMBLED INCORRECTLY. 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 | BLOOD RESERVOIR | KFM | TERUMO CARDIOVASCULAR SYSTEMS CORP. | NA | MD08 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |