FDA Adverse Event
Malfunction
Summary report: N
WALKMED INFUSION TRITON CLASSIC INFUSION PUMP
MDR report key: 5088629
·
Received September 18, 2015
Report
- Report Number
- 1723533-2015-00015
- Event Type
- Malfunction
- Date Received
- September 18, 2015
- Date of Event
- August 20, 2015
- Report Date
- August 20, 2015
- Manufacturer
- WALKMED INFUSION, LLC.
- Product Code
- FRN
- PMA / PMN Number
- K070529
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO, US
- Reporter Occupation
- SERVICE AND TESTING PERSONNEL
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 PRODUCT EVALUATION, WALKMED INFUSION OBSERVED THE DEVICE TO FAIL THE OPEN STATE FREE FLOW TEST. THE PUMP WAS INITIALLY SENT IN FOR A REPORTED BLANK DISPLAY SCREEN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 618657 | WALKMED INFUSION TRITON CLASSIC INFUSION PUMP | INFUSION PUMP | FRN | WALKMED INFUSION, LLC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |