FDA Adverse Event
Summary report: N
SARNS CENTRIFUGAL PUMP
MDR report key: 2083150
·
Received April 27, 2011
Report
- Report Number
- 1124841-2011-00204
- Date Received
- April 27, 2011
- Date of Event
- February 25, 2011
- Report Date
- April 27, 2011
- Manufacturer
- TERUMO CARDIOVASCULAR SYSTEMS CORPORATION
- Product Code
- KFM
- PMA / PMN Number
- K020998
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
TERUMO HAS NOT REC'D THE ACTUAL DEVICE FOR INVESTIGATION. TERUMO PLANS ON SUBMITTING A F/U REPORT WHEN THE INVESTIGATION IS COMPLETED AND MORE INFO BECOMES AVAILABLE. .
Description of Event or Problem · 1
THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR SYSTEMS THAT PRIOR TO CARDIOPULMONARY BYPASS SURGERY, DURING PRIME, THE CENTRIFUGAL PUMP MADE A "BIZARRE NOISE." THE PRODUCT WAS CHANGED OUT. THERE WAS NO PT INVOLVEMENT AS THIS OCCURRED DURING PRIME. THE SURGERY WAS COMPLETED SUCCESSFULLY AND W/O DELAY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SARNS CENTRIFUGAL PUMP | CENTRIFUGAL PUMP | KFM | TERUMO CARDIOVASCULAR SYSTEMS CORPORATION | 164275 | MM04 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |