FDA Adverse Event
Malfunction
Summary report: N
MEDFUSION 3500 SYRINGE INFUSION PUMP
MDR report key: 2920795
·
Received December 19, 2012
Report
- Report Number
- 2183502-2012-00611
- Event Type
- Malfunction
- Date Received
- December 19, 2012
- Date of Event
- November 26, 2012
- Report Date
- December 18, 2012
- Manufacturer
- SMITHS MEDICAL MD
- Product Code
- FRN
- PMA / PMN Number
- K040899
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, 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 OUT OF CALIBRATION. THEREFORE, 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 PATIENT INJURY OR ADVERSE EVENT WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MEDFUSION 3500 SYRINGE INFUSION PUMP | SYRINGE INFUSION PUMP | FRN | SMITHS MEDICAL MD | 3500 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |