FDA Adverse Event
Malfunction
Summary report: N
MEDFUSION 3500 SYRINGE INFUSION PUMP
MDR report key: 2842395
·
Received October 22, 2012
Report
- Report Number
- 2183502-2012-00491
- Event Type
- Malfunction
- Date Received
- October 22, 2012
- Date of Event
- August 16, 2012
- Report Date
- October 17, 2012
- Manufacturer
- SMITHS MEDICAL MD
- Product Code
- FRN
- PMA / PMN Number
- K040899
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OK, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DEVICE EVAL: THE SUSPECT DEVICE WAS RETURNED AND EVALUATED. EVAL OF THE PUMP EVENT HISTORY LOG OBSERVED CHECK CLUTCH/PLUNGER LEVER ALARMS. HOWEVER, FUNCTIONAL TESTING WAS UNABLE TO DUPLICATE THE ALARMS. THE POSITION POTENTIOMETER WAS REPLACED AS A PREVENTIVE MEASURE.
Description of Event or Problem · 1
A REPORT WAS RECEIVED THAT STATED THE PUMP ALARMED WITH MULTIPLE SYSTEM ISSUES IN THE EVENT HISTORY LOG SINCE (B)(6) 2011. NO PT INJURY OR ADVERSE EVENT WAS REPORTED. INVESTIGATION RESULTS FOUND A CHECK CLUTCH ALARM.
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 |