FDA Adverse Event
Malfunction
Summary report: N
WALKMED TRITON FP POLE MOUNT INFUSION PUMP
MDR report key: 6049321
·
Received October 21, 2016
Report
- Report Number
- 1723533-2016-00175
- Event Type
- Malfunction
- Date Received
- October 21, 2016
- Date of Event
- August 24, 2016
- Report Date
- September 15, 2016
- Manufacturer
- WALKMED INFUSION, LLC.
- Product Code
- FRN
- PMA / PMN Number
- K070529
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
WALKMED INFUSION'S APPROVED SERVICE CENTER, (B)(4) DISTRIBUTORS OBSERVED THE DEVICE IN QUESTION (SERIAL NUMBER (B)(4)) ALLOWED FLUID TO FLOW FREELY. PUMP SERIAL NUMBER (B)(4) WAS NOT REPAIRED AND WAS REMOVED FROM SERVICE AS THIS PRODUCT LINE IS UNDER A RECALL INITIATED 14 JUNE 2016. A REVIEW OF THE MANUFACTURING RECORDS DID NOT REVEAL ANY NONCONFORMITIES RELATED TO THE REPORTED EVENT. EVALUATED BY APPROVED SERVICE CENTER.
Description of Event or Problem · 1
DURING TESTING, THE DEVICE IN QUESTION WAS OBSERVED TO ALLOW FLUID TO FLOW FREELY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 698959 | WALKMED TRITON FP POLE MOUNT INFUSION PUMP | INFUSION PUMP | FRN | WALKMED INFUSION, LLC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |