FDA Adverse Event
Malfunction
Summary report: N
MEDFUSION 3500 SYRINGE INFUSION PUMP
MDR report key: 1882475
·
Received October 21, 2010
Report
- Report Number
- 2183502-2010-00469
- Event Type
- Malfunction
- Date Received
- October 21, 2010
- Date of Event
- September 20, 2010
- Report Date
- October 19, 2010
- Manufacturer
- SMITHS MEDICAL MD
- Product Code
- FRN
- PMA / PMN Number
- K040899
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DEVICE EVAL: THE SUSPECT DEVICE WAS RETURNED AND EVALUATED. TESTING INDICATED THAT THE POSITION POTENTIOMETER WAS INTERMITTENTLY NON-FUNCTIONAL DUE TO A CONTAMINATION BY A FOREIGN MATERIAL. THE POSITION POTENTIOMETER WAS REPLACED. AFTER REPAIR, THE DEVICE WAS FOUND TO PASS ALL DELIVERY, ACCURACY AND FUNCTIONAL TESTS. OUR QUALITY ASSURANCE ENGINEER DETERMINED THAT THE COMPLAINT WAS RELATED TO MAINTENANCE AND USER HANDLING.
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 | NONE |