FDA Adverse Event
Summary report: N
SARNS CENTRIFUGAL PUMP
MDR report key: 2021936
·
Received March 7, 2011
Report
- Report Number
- 1124841-2011-00096
- Date Received
- March 7, 2011
- Date of Event
- February 15, 2011
- Report Date
- February 16, 2011
- Manufacturer
- TERUMO CARDIOVASCULAR SYSTEMS CORP.
- Product Code
- KFM
- PMA / PMN Number
- K020998
- Removal / Correction Number
- NA
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
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. (B)(4).
Description of Event or Problem · 1
THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR SYSTEMS THAT DURING CARDIOPULMONARY BYPASS SURGERY, THE CENTRIFUGAL PUMP WAS NOISY. TWO OCCURRENCES WERE NOTED; HOWEVER, EVENT INFO WAS ONLY GIVEN FOR ONE OCCURRENCE. THE PRODUCT WAS NOT CHANGED OUT. THERE WAS NO PT INJURY. THE SURGERY WAS COMPLETED SUCCESSFULLY AND WITHOUT DELAY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SARNS CENTRIFUGAL PUMP | CENTRIFUGAL PUMP | KFM | TERUMO CARDIOVASCULAR SYSTEMS CORP. | 164275X | NA03 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |