Catalog Number 5C8310R |
Device Problems
Degraded (1153); Volume Accuracy Problem (1675)
|
Patient Problem
No Patient Involvement (2645)
|
Event Date 10/07/2014 |
Event Type
malfunction
|
Manufacturer Narrative
|
(b)(4).The homechoice device was returned and evaluated by the product analysis lab (pal).A review of the service history revealed no indication that the parts replaced during servicing caused or contributed to the reported event.A visual inspection was performed with no abnormalities noted.The homechoice device received a returned instrument testing evaluation (rite).This evaluation included functional and electrical testing of the device.The device passed electrical rite but failed functional rite for volumetric accuracy.The cause was determined to be a deteriorated piston foam.The piston foam was replaced to resolve the problem.Should additional relevant information become available, a supplemental report will be submitted.
|
|
Event Description
|
During evaluation of a returned homechoice device, a baxter technician determined the device failed the volume accuracy test.Device failed during evaluation, no patient involved.
|
|
Manufacturer Narrative
|
(b)(4).The homechoice (hc) was returned and is currently in the process of being evaluated.Should additional relevant information become available, a follow-up report will be submitted.
|
|
Search Alerts/Recalls
|