FDA Adverse Event
Malfunction
Summary report: N
WALKMED INFUSION TRITON FP POLE MOUNT INFUSION PUMP
MDR report key: 5058336
·
Received September 4, 2015
Report
- Report Number
- 1723533-2015-00014
- Event Type
- Malfunction
- Date Received
- September 4, 2015
- Date of Event
- August 4, 2015
- Report Date
- August 6, 2015
- Manufacturer
- WALKMED INFUSION, LLC.
- Product Code
- FRN
- PMA / PMN Number
- K070529
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE IN QUESTION WAS RETURNED TO WALKMED INFUSION FOR PRODUCT EVALUATION. THE DEVICE WAS SUBJECTED THROUGH A COMPLETE PRODUCT EVALUATION TESTING AT WHICH POINT IT WAS DISCOVERED THAT THERE WAS AN OPEN STATE OF FREE FLOW WHEN THE IV TUBING IS INSERTED AND DOOR CLOSED. WALKMED HAS PERFORMED A FAILURE INVESTIGATION AND IDENTIFIED NORMAL WEARING COMPONENTS AS THE CAUSE.
Description of Event or Problem · 1
DURING PUMP SET-UP, THE IV WAS NOTED TO BE CONSISTENTLY DRIPPING WITHOUT THE PUMP BEING STARTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 588475 | WALKMED INFUSION TRITON FP POLE MOUNT INFUSION PUMP | INFUSION PUMP | FRN | WALKMED INFUSION, LLC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |