MAUDE Adverse Event Report: FRESENIUS LIBERTY SELECT CYCLER; PERITONEAL DIALYSIS CYCLER

Model Number 180343

Device Problems Improper or Incorrect Procedure or Method (2017); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Death (1802); Unspecified Infection (1930); Unspecified Infection (1930); Sepsis (2067); Sepsis (2067); Peritonitis (2252); Peritonitis (2252)

Event Date 04/29/2019

Event Type  Death  

Event Description

Home dialysis pt was admitted to an outside hosp on (b)(6) 2019 for peritonitis, hypoxia, acute bacterial bronchitis and wheezing.Pt passed away on (b)(6) 2019.Pt was admitted to an outside hosp on (b)(6) 2019 and was diagnosed with peritonitis, hypoxia, acute bacterial bronchitis, and wheezing.The pt's medical condition continued to deteriorate during the admission.The pt passed away on (b)(6) 2019.The pt's home peritoneal dialysis cycler had recently been changed to the fresenius liberty model.It is unk as to what if any the switch to the new machine contributed to his death.Infectious disease has reported a spike in peritoneal cases following the change over to the fresenius liberty cycler starting in late (b)(6) 2019.

• Brand Name: LIBERTY SELECT CYCLER
• Type of Device: PERITONEAL DIALYSIS CYCLER
• Manufacturer (Section D): FRESENIUS; concord CA
• MDR Report Key: 8671129
• MDR Text Key: 241261718
• Report Number: 8671129
• Device Sequence Number: 1
• Product Code: FKO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 05/30/2019

1 Device was Involved in the Event

2 Patient was Involved in the Event

• Date FDA Received: 05/31/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 180343
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/30/2019
• Distributor Facility Aware Date: 05/17/2019
• Device Age: 1 MO
• Event Location: Hospital
• Date Report to Manufacturer: 05/30/2019
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Death
• Patient Age: 74 YR
• Patient Weight: 93