FDA Adverse Event
Malfunction
Summary report: N
MEDFUSION 3500 SYRINGE INFUSION PUMP
MDR report key: 3012513
·
Received February 20, 2013
Report
- Report Number
- 2183502-2013-00040
- Event Type
- Malfunction
- Date Received
- February 20, 2013
- Date of Event
- January 21, 2013
- Report Date
- February 19, 2013
- Manufacturer
- SMITHS MEDICAL MD
- Product Code
- FRN
- PMA / PMN Number
- K040899
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DEVICE EVALUATION: THE SUSPECT DEVICE WAS RETURNED AND EVALUATED. TESTING INDICATED THAT THE POSITION POTENTIOMETER WAS WORN OUT DUE TO THE AGE OF THE PUMP. THE POSITION POTENTIOMETER WAS REPLACED. AFTER REPAIR, THE DEVICE WAS FOUND TO PASS ALL DELIVERY, ACCURACY AND FUNCTIONAL TESTS.
Description of Event or Problem · 1
A REPORT WAS RECEIVED THAT STATED THE PUMP ALARMED "CHECK CLUTCH." NO PT INJURY OR ADVERSE EVENT WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 74801 | MEDFUSION 3500 SYRINGE INFUSION PUMP | SYRINGE INFUSION PUMP | FRN | SMITHS MEDICAL MD | 3500 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |