FDA Adverse Event
Malfunction
Summary report: N
MEDFUSION 3500 SYRINGE INFUSION PUMP
MDR report key: 3170341
·
Received May 24, 2013
Report
- Report Number
- 2183502-2013-00247
- Event Type
- Malfunction
- Date Received
- May 24, 2013
- Date of Event
- April 24, 2013
- Report Date
- May 22, 2013
- Manufacturer
- SMITHS MEDICAL
- Product Code
- FRN
- PMA / PMN Number
- K040899
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CT, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE SUSPECT DEVICE WAS RETURNED AND EVALUATED. TESTING INDICATED THAT THE POSITION POTENTIOMETER CABLE WAS LOOSE. THE POSITION POTENTIOMETER CABLE WAS REINSERTED INTO THE PROPER POSITION. 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 PATIENT INJURY OR ADVERSE EVENT WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 231053 | MEDFUSION 3500 SYRINGE INFUSION PUMP | SYRINGE INFUSION PUMP | FRN | SMITHS MEDICAL | 3500 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NONE |