FDA Adverse Event
Malfunction
Summary report: N
MEDFUSION 3500 SYRINGE INFUSION PUMP
MDR report key: 4232450
·
Received October 24, 2014
Report
- Report Number
- 2183502-2014-00803
- Event Type
- Malfunction
- Date Received
- October 24, 2014
- Report Date
- October 24, 2014
- Manufacturer
- SMITHS MEDICAL
- Product Code
- FRN
- PMA / PMN Number
- K040899
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE IS CURRENTLY BEING EVALUATED; THE MANUFACTURER WILL FILE FOLLOW-UP REPORT DETAILING THE RESULTS OF THE EVALUATION ONCE IT IS COMPLETED.
Description of Event or Problem · 1
A REPORT WAS RECEIVED THAT STATED THE PUMP ALARMED "CHECK CLUTCH." NO PATIENT INJURY OR ADVERSE EVENT WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 677953 | MEDFUSION 3500 SYRINGE INFUSION PUMP | FRN - SYRINGE INFUSION PUMP | FRN | SMITHS MEDICAL | 3500 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |