MAUDE Adverse Event Report: ERIKA DE REYNOSA, S.A. DE C.V. LIBERTY CYCLER SET, SINGLE CONN./EXT. DL; SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

Model Number 050-87216

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Inflammation (1932); Peritonitis (2252)

Event Date 01/01/2018

Event Type  Injury  

Manufacturer Narrative

The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.  clinical investigation: a temporal relationship does not exist between ccpd therapy utilizing the liberty select cycler, liberty cycler set and the adverse event of sclerotic peritonitis as it was reported this chronic non-infectious condition preexisted pd therapy.The cause of the patient¿s sclerotic peritonitis remains unknown and there was no report pd therapy exacerbated this condition.Sclerotic peritonitis is a rare condition that involves a non-infectious process of peritoneal inflammation of unknown etiology and may be multi-factorial.Due to the confirmation that this patient¿s diagnosis of sclerotic peritonitis predated the start of pd therapy, the liberty select cycler and liberty cycler set can be excluded as the cause of this event.Based on the available information, there is no specific allegation or objective evidence indicating a fresenius device(s) or product(s) deficiency or malfunction, caused or contributed to the patient¿s adverse event.

Event Description

It was reported a peritoneal dialysis (pd) patient on continuous cyclic pd (ccpd) therapy on the liberty select cycler is in process of transferring to in-center hemodialysis (hd) due to sclerosing peritonitis.There was no specific allegation this adverse event was due to a deficiency or malfunction of any fresenius product(s) or device(s) in the initial reporting.Upon follow up, the patient¿s peritoneal dialysis registered nurse (pdrn) reported this patient received a diagnosis of sclerotic peritonitis that preexisted pd therapy on an unknown date.It was reported the patient had not experienced an infection and this chronic condition was from unknown etiology.Additionally, the patient has not been hospitalized and did not require additional medical intervention outside ongoing pd therapy support.The patient is currently transitioning to in-center hd therapy as the patient¿s sclerotic peritonitis has increasingly caused complications during ccpd therapy on the liberty select cycler at home.It was confirmed the patient¿s diagnosis of sclerotic peritonitis was not due to a deficiency or malfunction of any fresenius product(s) or device(s).The patient will continue hd for renal replacement therapy on an in-center basis.

Manufacturer Narrative

Plant investigation: the sample was not returned to the manufacturer and the lot number was not provided.A manufacturing review was performed on the products shipped to the patient for the three (3) month time frame which immediately preceded the event occurrence date.This review included the lot numbers for all fresenius liberty cycler sets shipped to this account within the selected time frame.The entire set of lots have been sold and distributed.There were no non-conformance's or abnormalities identified during the manufacturing process which could be associated with the reported event.An investigation of the device history records (dhr) was conducted and confirmed that the results of the in-progress and final quality control (qc) testing met all requirements.The product lots involved met all specifications for release.A review of the dhr did not reveal a probable cause for the customer complaint.As a physical evaluation could not be performed, a definitive conclusion regarding the reported incident could not be reached and a cause could not be confirmed.

• Brand Name: LIBERTY CYCLER SET, SINGLE CONN./EXT. DL
• Type of Device: SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
• Manufacturer (Section D): ERIKA DE REYNOSA, S.A. DE C.V.; mike allen #1331; parque industrial reynosa; reynosa 88780 ; MX 88780
• MDR Report Key: 10840415
• MDR Text Key: 216322720
• Report Number: 8030665-2020-01672
• Device Sequence Number: 1
• Product Code: FKX
• UDI-Device Identifier: 00840861100750
• UDI-Public: 00840861100750
• Combination Product (y/n): N
• PMA/PMN Number: K043363
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 12/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 050-87216
• Device Catalogue Number: 050-87216
• Was Device Available for Evaluation?: No
• Device Age: MO
• Date Manufacturer Received: 11/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: DELFLEX PD FLUID; LIBERTY SELECT CYCLER
• Patient Outcome(s): Required Intervention
• Patient Weight: 87