Model Number LIB |
Device Problems
Device Issue (2379); Expulsion (2933)
|
Patient Problems
Dementia (1808); Encephalopathy (1833); Hypervolemia (2664)
|
Event Date 11/20/2015 |
Event Type
Injury
|
Manufacturer Narrative
|
The plant and medical review investigation has not yet been completed.A follow up report will be filed upon completion of the investigations.
|
|
Event Description
|
A peritoneal dialysis (pd) patient reported they were just released from the hospital.Upon follow up with the patient's clinic, it was indicated the patient was hospitalized for inadequate dialysis and altered mental state.The patient was performing treatment daily and performing four exchanges a day on the cycler.After the patient's hospitalization, the patient's physician added an additional dwell and day-time exchange to the patient's dialysis treatments and the patients physical and metal state have improved.No other medical intervention was required.
|
|
Manufacturer Narrative
|
A return product investigation was not performed as the cycler was not placed in the complaint for the reported symptoms.Field service investigation is not performed on cyclers.In addition, the device history review confirmed the labeling, material, and process controls were within spec.Medical records are clear that the source of altered mental status was not definitely determined.There was no documentation in the medical record that indicated there was a causal relationship between the pt's liberty cycler and peritoneal dialysis solution and the pt's encephalopathy.It appears according to the medical record that the change in pd might have contributed to the pt's encephalopathy.Dementia and a change in memory loss prior to hospitalization in addition to acute encephalopathy are likely contributors to the change in mental status for this hospital admission.
|
|
Event Description
|
Patient is (b)(6) male who presented to the hospital with altered mental status.During the previous eight days, the pt changed from continuous ambulatory peritoneal dialysis (capd) five times per day to nightly continuous cycling peritoneal dialysis (ccpd).The pt's wife stated that this change in the pt's peritoneal dialysis had led to lower output.Pt's discharge diagnosis was acute encephalopathy, likely uremic.Pt received manual dialysis exchanges every four hours while in the hospital and improved and was discharged (b)(6) 2014.
|
|
Search Alerts/Recalls
|