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 02/22/2024

Event Type  Injury  

Event Description

It was reported to fresenius that the peritoneal dialysis (pd) patient went to the hospital due to peritonitis.Follow-up with the patient¿s peritoneal dialysis registered nurse (pdrn) was conducted.However, the pdrn did not have access to any hospital records related to the peritonitis event.The patient was expected in the pd clinic with their discharge paperwork.Attempts to obtain additional information after the patient visit were unsuccessful.

Manufacturer Narrative

Clinical review: there is a temporal relationship between peritoneal dialysis therapy utilizing the liberty cycler set and the patient event of peritonitis.However, there is no documentation in the complaint file to show a causal relationship between the adverse event and use of the liberty cycler set.Additionally, there is no allegation of a device malfunction or deficiency, or cycler set defect reported for the peritonitis event.Although no information was provided related to culture results or the determined cause of the peritonitis, 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 the liberty cycler set can be excluded as the cause of the patient¿s reported peritonitis event.The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity. .

Manufacturer Narrative

Plant investigation: as the device was not returned to the manufacturer, a physical evaluation could not be performed.A batch records review was conducted by the manufacturer for the reported lot.There were no non-conformances or abnormalities identified during the manufacturing process which could be associated with the reported event.The entire lot has been sold and distributed.In addition, a device history review was performed and confirmed that the results of the in-progress and final quality control (qc) testing met all requirements.The lot met all specifications for release.A product history review 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.

Event Description

It was reported to fresenius that the peritoneal dialysis (pd) patient went to the hospital due to peritonitis.Follow-up with the patient¿s peritoneal dialysis registered nurse (pdrn) was conducted.However, the pdrn did not have access to any hospital records related to the peritonitis event.The patient was expected in the pd clinic with their discharge paperwork.Attempts to obtain additional information after the patient visit were unsuccessful.

• 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
• Manufacturer (Section G): ERIKA DE REYNOSA, S.A. DE C.V.; director, quality systems; 900 w zaragosa drive suite d; pharr TX 78577
• Manufacturer Contact: jessica trujillo ; 920 winter st; waltham, MA 02451 ; 6174175172
• MDR Report Key: 18847880
• MDR Text Key: 337023047
• Report Number: 0008030665-2024-00247
• Device Sequence Number: 1
• Product Code: FKX
• UDI-Device Identifier: 00840861100736
• UDI-Public: 00840861100736
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K173718
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional,User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 03/27/2024

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
• Device Operator: Lay User/Patient
• Device Catalogue Number: 050-87212
• Device Lot Number: 23DR08108
• Was Device Available for Evaluation?: No
• Device Age: MO
• Initial Date Manufacturer Received: 02/23/2024
• Initial Date FDA Received: 03/06/2024
• Supplement Dates Manufacturer Received: 03/21/2024
• Supplement Dates FDA Received: 03/27/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/18/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: DELFLEX PD FLUID.; DELFLEX PD FLUID.; LIBERTY SELECT CYCLER.; LIBERTY SELECT CYCLER.
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Male