MAUDE Adverse Event Report: ERIKA DE REYNOSA, S.A. DE C.V. LIBERTY CYCLER SET, DUAL PATIENT CONNECT; SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

Catalog Number 050-87212

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

Patient Problem Peritonitis (2252)

Event Date 07/11/2019

Event Type  Injury  

Manufacturer Narrative

The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity. .

Event Description

A peritoneal dialysis (pd) patient reported that they developed peritonitis while using the liberty select cycler.It was reported that the event required prolonged hospitalization, however, the patient has recovered from the event.Multiple attempts have been made requesting additional information, however to date information has not been provided.

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-conformances 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.

Manufacturer Narrative

Clinical investigation: a temporal relationship exists between continuous cyclic peritoneal dialysis (ccpd) therapy utilizing the liberty select cycler, liberty cycler set and the adverse event of peritonitis which required hospitalization.Per the peritoneal dialysis registered nurse (pdrn), the cause of the peritonitis is attributed to ¿patient error¿ (specifics not provided).The pdrn¿s statement is further evidenced by the identified organism, as klebsiella bacteria are normally found in the human intestines and stool.Additionally, it is well established those individuals undergoing pd therapy are at high risk for infections of the peritoneum.Based on the information available, the liberty select cycler and liberty cycler set can be disassociated from the event, as there is no allegation or objective evidence indicating a product deficiency or malfunction caused or contributed to the serious adverse event.Furthermore, to the knowledge of the reviewer, the patient continues to utilize the same liberty select cycler without any reported issues or allegations of machine malfunction or deficiency.

Event Description

Additional information was received from the patient¿s peritoneal dialysis registered nurse (pdrn) on (b)(6) 2019.The document confirms the patient¿s hospitalization for peritonitis on (b)(6) 2019.Peritoneal effluent fluid cultures were obtained on (b)(6) 2019 and returned positive for gram-negative klebsiella oxytoca.Details surrounding the hospitalization were not provided; however, the patient was discharged on (b)(6) 2019 and has recovered from the event.The pdrn reported that the cause of the peritonitis was ¿patient error¿ (specifics not provided), and the patient was given 3 days of retraining and a home visit.Follow-up pd cultures and cell counts revealed steady improvement from (b)(6) 2019 through (b)(6) 2019 (see laboratory results).There was no allegation of a fresenius device(s) or product(s) malfunction or deficiency, and the patient continues to perform continuous cyclic peritoneal dialysis (ccpd) therapy without issue.

• Brand Name: LIBERTY CYCLER SET, DUAL PATIENT CONNECT
• 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: 8839264
• MDR Text Key: 152613000
• Report Number: 8030665-2019-01169
• Device Sequence Number: 1
• Product Code: FKX
• UDI-Device Identifier: 00840861100736
• UDI-Public: 00840861100736
• 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,consum
• Type of Report: Initial,Followup,Followup
• Report Date: 09/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/29/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: 050-87212
• Was Device Available for Evaluation?: No
• Device Age: MO
• Date Manufacturer Received: 09/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: DELFLEX PD FLUID; LIBERTY SELECT CYCLER
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 52 YR
• Patient Weight: 97