MAUDE Adverse Event Report: CONCORD MANUFACTURING LIBERTY PDX CYCLER ASSY (NON-VALUATED); SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

Model Number	LIBERTY PDX
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hernia (2240)
Date of Event	05/23/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A supplemental report will be submitted upon completion of the plant¿s investigation.
Event or Problem Description
During routine follow up on a customer experience, the patient¿s peritoneal dialysis nurse reported that the patient was recovering from multiple hernia repairs.The patient was treated at an outpatient clinic.The hernias reportedly developed after the patient started peritoneal dialysis treatments.Patient¿s peritoneal dialysis treatments have been adjusted to compensate for the hernia repair.Additional information was solicited.
Additional Manufacturer Narrative
There is a temporal relationship between ccpd therapy with the liberty pdx modem (b)(6), the liberty pdx cycler and the patient¿s adverse event(s) of multiple hernia¿s (unknown type) and subsequent out-patient center treatment.Hernia is a commonly known complication in pd therapy due to physiologic increased abdominal pressure from the dialysate during pd treatment.Moreover, the pdrn stated the causality for the event was unknown, however it was confirmed the hernia¿s developed while the patient was using ccpd for rrt.Therefore, based on the information available, there is no documentation or indication a fresenius device(s) caused or contributed to a serious adverse patient outcome.Additionally, there is no allegation of the machine malfunctioning or the machine not performing as expected.Plant investigation: the alleged event is not confirmed.The device was not returned to the manufacturing plant for investigation.An investigation of the product history records was no conducted since the serial number of the alleged device is unknown.

• Brand Name: LIBERTY PDX CYCLER ASSY (NON-VALUATED)
• Common Device Name: SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
• Manufacturer (Section D): CONCORD MANUFACTURING; 4040 nelson avenue; concord CA 94520
• MDR Report Key: 7564113
• Report Number: 2937457-2018-01537
• Device Sequence Number: 2073769
• Product Code: FKX
• UDI-Device Identifier: 00840861100989
• UDI-Public: 00840861100989
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K141145
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Model Number: LIBERTY PDX
• Device Catalogue Number: RTLR180237
• Was Device Available for Evaluation?: No
• Device Age: MO
• Initial Date Received by Manufacturer: 05/23/2018
• Supplement Date Received by Manufacturer: 06/04/2018
• Initial Report FDA Received Date: 06/03/2018
• Supplement Report FDA Received Date: 06/08/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ISOSORBIDE MONONITRATE; LIBERTY CYCLER SET; MIDODRINE; PD SOLUTION
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 66 YR