The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.Clinical investigation: there is a possible temporal relationship between pd therapy utilizing the liberty select cycler with cycler set and the patient event of possible peritonitis.However, it is unknown if this anonymous patient was utilizing fresenius product(s) at the time their reported possible peritonitis event was diagnosed or if peritonitis was the reason for their hospitalization.Furthermore, there is no documentation in the complaint file to show a causal relationship between the possible peritonitis event and use of the liberty select cycler with cycler set.Additionally, there is no allegation of a device malfunction or deficiency, or cycler set defect reported for the event.All pd patients are at risk of peritonitis due to a compromised immune system and the increase of potential for microbial contamination from dialysis techniques.Most cases of peritonitis are caused by touch contamination by the patient with the pd catheter being a source of entry for organisms into the peritoneum.Based on the limited information and no allegation of a malfunction, deficiency or defect and no confirmation that any fresenius product(s) were utilized, the liberty select cycler and cycler set can be excluded as the cause of the patient¿s reported possible peritonitis event.
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