FDA Adverse Event
Malfunction
Summary report: N
MEDUFSION 3500 SYRINGE INFUSION PUMP
MDR report key: 1850463
·
Received September 21, 2010
Report
- Report Number
- 2183502-2010-00414
- Event Type
- Malfunction
- Date Received
- September 21, 2010
- Date of Event
- August 23, 2010
- Report Date
- September 20, 2010
- Manufacturer
- SMITHS MEDICAL MD
- Product Code
- FRN
- PMA / PMN Number
- K040899
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MS, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
MANUFACTURER COMPLETED THE ENTIRE FORM. DEVICE EVALUATION: THE SUSPECT DEVICE WAS RETURNED AND EVALUATED. TESTING INDICATED THAT THE POSITION POTENTIOMETER WAS NON-FUNCTIONAL DUE TO A BROKEN SLIDE TAB. THE POSITION POTENTIOMETER WAS REPLACED. ADDITIONALLY THE PLUNGER TUBE ASSEMBLY WAS BENT. 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 | MEDUFSION 3500 SYRINGE INFUSION PUMP | SYRINGE INFUSION PUMP | FRN | SMITHS MEDICAL MD | 3500 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NONE |