Model Number LIBERTY CYCLER SET, SINGLE PATIENT CONN |
Device Problems
Fluid/Blood Leak (1250); Hole In Material (1293)
|
Patient Problems
Abdominal Pain (1685); Vomiting (2144)
|
Event Date 05/08/2018 |
Event Type
malfunction
|
Manufacturer Narrative
|
A supplemental report will be submitted upon completion of the plant¿s investigation.
|
|
Event Description
|
Peritoneal dialysis nurse reported that during peritoneal dialysis treatment with a liberty cycler, the cassette ¿exploded¿ during the second drain.Follow up with the peritoneal dialysis nurse indicates that the patient was at the clinic and was being trained on use with the cycler.It is unknown if the cycler alarmed when the leak was encountered.The patient reportedly developed abdominal pain and vomiting.The patient was prescribed prophylactic antibiotics.The patient was not culture.Patient¿s effluent was reportedly clear.The patient has resumed treatment with no further complications.
|
|
Manufacturer Narrative
|
The manufacturing plant received on (b)(6) 2018 a actual sample of code (b)(4) without its original package.During disinfection the alleged failure was confirmed, a leak was found on the cassette film.A visual inspection was performed to actual sample and noticed a pin hole at the cassette film.An investigation of the product history records was conducted by the manufacturer.There were no deviations or non-conformances during the manufacturing process.In addition, the product history review confirmed the labeling, material, and process controls were within specification.
|
|
Event Description
|
".".
|
|
Manufacturer Narrative
|
Correction: catalogue number.A supplemental report will be submitted upon completion of the plant¿s investigation.
|
|
Search Alerts/Recalls
|