FDA Adverse Event
Malfunction
Summary report: N
WALKMED INFUSION TRITON FP INFUSION PUMP
MDR report key: 5114675
·
Received September 30, 2015
Report
- Report Number
- 1723533-2015-00017
- Event Type
- Malfunction
- Date Received
- September 30, 2015
- Date of Event
- August 31, 2015
- Report Date
- August 31, 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 UNDERWENT PRODUCT EVALUATION TESTING AT WALKMED INFUSION DURING WHICH IT WAS DISCOVERED THAT THERE WAS AN OPEN STATE OF FREE FLOW WHEN THE IV TUBING IS INSERTED AND DOOR CLOSED. WALKMED INFUSION PERFORMED FURTHER FAILURE INVESTIGATION AND IDENTIFIED THE FRONT PANEL HOUSING AS THE CAUSE DUE TO A MAINTENANCE DEFICIENCY (PUMP HAD NOT BEEN RETURNED FOR THE RECOMMENDED ANNUAL MAINTENANCE). .
Description of Event or Problem · 1
DURING PRODUCT EVALUATION, WALKMED INFUSION OBSERVED THE DEVICE TO HAVE AN OPEN STATE OF FREE FLOW. THE PUMP WAS INITIALLY SENT FOR A REPORTED "SYSTEM ERROR 6" OCCURRING DURING TREATMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 646422 | WALKMED INFUSION TRITON FP INFUSION PUMP | INFUSION PUMP | FRN | WALKMED INFUSION, LLC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |