FDA Adverse Event
Malfunction
Summary report: N
WALKMED TRITON POLE MOUNT INFUSION PUMP
MDR report key: 4881568
·
Received July 1, 2015
Report
- Report Number
- 1723533-2015-00010
- Event Type
- Malfunction
- Date Received
- July 1, 2015
- Report Date
- August 22, 2013
- 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 AND INSPECTED BY WALKMED INFUSION PERSONNEL. WALKMED INFUSION OBSERVED THE DEVICE IN QUESTION FAILED THE "AIR IN LINE" TEST DUE TO A FAULTY BUBBLE DETECTOR. THE REPORTED EVENT WAS CONFIRMED. THE BUBBLE DETECTOR WAS REPLACED AND THE DEVICE PASSED A SUBSEQUENT "AIR IN LINE" TEST. A REVIEW OF THE MANUFACTURING RECORDS DID NOT REVEAL ANY NONCONFORMITIES RELATED TO THE REPORTED EVENT.
Description of Event or Problem · 1
THE CLINICAL STAFF OBSERVED THE DEVICE IN QUESTION WAS NOT ALARMING WHEN AIR PASSED THE DEVICE'S AIR DETECTION SYSTEM. THE CLINICAL STAFF WAS ABLE TO PREVENT INFUSION OF AIR INTO THE PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 426368 | WALKMED TRITON POLE MOUNT INFUSION PUMP | POLE MOUNT INFUSION PUMP | FRN | WALKMED INFUSION, LLC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |