FDA Adverse Event
Malfunction
Summary report: N
SARNS CENTRIFUGAL PUMP
MDR report key: 2945210
·
Received January 31, 2013
Report
- Report Number
- 1124841-2013-00030
- Event Type
- Malfunction
- Date Received
- January 31, 2013
- Date of Event
- January 17, 2013
- Report Date
- January 17, 2013
- Manufacturer
- TERUMO CARDIOVASCULAR SYSTEM CORP
- Product Code
- KFM
- PMA / PMN Number
- K112229
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
TERUMO HAS NOT RECEIVED ACTUAL DEVICE FOR INVESTIGATION. TERUMO PLANS ON SUBMITTING A FOLLOW-UP 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 PRIOR TO CARDIOPULMONARY BYPASS SURGERY, DURING PRIME, THE CENTRIFUGAL PUMP SQUEALED. THERE WAS NO PT INVOLVEMENT AS THIS OCCURRED DURING PRIME. THERE WAS A SHORT DELAY (AMOUNT OF TIME UNK). THE PRODUCT WAS CHANGED OUT. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 43245 | SARNS CENTRIFUGAL PUMP | CENTRIFUGAL PUMP | KFM | TERUMO CARDIOVASCULAR SYSTEM CORP | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |