|
Model Number LIBERTY CYCLER UL |
Device Problems
Mechanical Problem (1384); Adverse Event Without Identified Device or Use Problem (2993)
|
Patient Problem
Hypervolemia (2664)
|
Event Date 06/01/2018 |
Event Type
Injury
|
Manufacturer Narrative
|
Clinical review: lack of sufficient information precludes a meaningful assessment in this case.However, it is known that inadequate or missed dialysis can lead to hospitalization; therefore, a possible causal relationship cannot be excluded due to the allegations against the device.Serial numbers for the liberty cyclers in question are unknown and the liberty cyclers are not available for manufacturer product investigation; therefore, it is unknown whether or not the liberty cyclers were performing according to specifications.Plant investigation: the alleged event is not confirmed.The device was not returned to the manufacturing plant for investigation.Since the serial number of the alleged device is unknown, a device history review could not be performed.
|
|
Event Description
|
On (b)(4) 2018, fmc rtg, llc received notification that on (b)(6) 2018 a patient (pt.) on continuous cycling peritoneal dialysis (ccpd) filed a voluntary medwatch (mw5077784) form for a serious injury allegedly related to the liberty cycler.The pt.Reported not being able to properly dialyze due to failure of two liberty cyclers while away from home at a conference.Upon return on (b)(6) 2018, the pt.Required emergency hospitalization to sustain life.Details surrounding patient demographics/information, hospitalization course and liberty cycler serial numbers are unknown.
|
|
Search Alerts/Recalls
|
|
|