FDA Adverse Event
Malfunction
Summary report: N
WALKMED TRITON POLE MOUNT INFUSION PUMP
MDR report key: 4254740
·
Received November 5, 2014
Report
- Report Number
- 1723533-2014-00025
- Event Type
- Malfunction
- Date Received
- November 5, 2014
- Date of Event
- October 7, 2014
- Report Date
- November 5, 2014
- Manufacturer
- WALKMED INFUSION LLC
- Product Code
- FRN
- PMA / PMN Number
- K070529
- Report Source
- Manufacturer report
- Reporter Location
- CO, US
- Reporter Occupation
- SERVICE AND TESTING PERSONNEL
Narratives
Additional Manufacturer Narrative · 1
THE INVESTIGATION FOR THE PUMP IN QUESTION HAS NOT BEEN COMPLETED. A FOLLOW UP REPORT WILL BE FILED WITHIN 30 CALENDAR DAYS TO DISCLOSE THE INVESTIGATION FINDINGS.
Description of Event or Problem · 1
A CUSTOMER REPORTED THE DEVICE IN QUESTION HAD OVER DELIVERED FLUIDS BY 22 %. ONCE RECEIVED, WALKMED INFUSION'S SERVICE TECHNICIANS PERFORMED A DELIVERY ACCURACY TEST. THE DEVICE FAILED THIS TEST AS IT HAD OVER DELIVERED BY 27%.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 710075 | WALKMED TRITON POLE MOUNT INFUSION PUMP | FRN | WALKMED INFUSION LLC | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |