|
Catalog Number 5C8310R |
Device Problems
Degraded (1153); Volume Accuracy Problem (1675)
|
Patient Problem
No Patient Involvement (2645)
|
Event Date 09/24/2014 |
Event Type
malfunction
|
Event Description
|
During evaluation of a returned homechoice (hc) device, a baxter technician determined the hc machine failed fluid volume accuracy testing.Device failed during evaluation, no patient involved.
|
|
Manufacturer Narrative
|
(b)(4).The device has been received and the evaluation is in progress.Should additional relevant information become available, a follow-up report will be submitted.
|
|
Manufacturer Narrative
|
(b)(4).The device was returned to baxter and an evaluation was performed to investigate the reported problem.A review of the event history log did not identify issues related to the reported problem.A review of the service history revealed no previous service events that would cause or contribute to the reported problem.An internal and external visual inspection revealed no problems.A check of the pneumatic system found all pressures to be correct and stable.The device passed the returned instrument testing evaluation (rite) electrical testing but failed the rite functional testing due to multiple fills and drains being outside of volumetric specifications.A test article piston foam was installed and the device was able to pass the volumetric accuracy testing.The direct cause of this problem was deteriorated piston foam.The deteriorated piston foam was scrapped to solve the problem.Should additional relevant information become available, a follow-up report will be submitted.
|
|
Search Alerts/Recalls
|
|
|