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

Catalog Number 050-87216

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

Patient Problem Peritonitis (2252)

Event Date 01/01/2024

Event Type  Injury  

Manufacturer Narrative

The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.Clinical investigation: there is a possible temporal relationship between pd therapy utilizing the liberty select cycler with cycler set and the patient event of possible peritonitis.However, it is unknown if this anonymous patient was utilizing fresenius product(s) at the time their reported possible peritonitis event was diagnosed or if peritonitis was the reason for their hospitalization.Furthermore, there is no documentation in the complaint file to show a causal relationship between the possible peritonitis event and use of the liberty select cycler with cycler set.Additionally, there is no allegation of a device malfunction or deficiency, or cycler set defect reported for the event.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 and no confirmation that any fresenius product(s) were utilized, the liberty select cycler and cycler set can be excluded as the cause of the patient¿s reported possible peritonitis event.

Event Description

A hospital registered nurse (rn) contacted fresenius technical support for a patient line blocked alarm received during treatment on a liberty select cycler.The rn stated that they did not add heparin and the patient normally uses heparin when performing treatment at home.Upon follow-up with the rn, they stated they could not remember the patient¿s name but believed they were hospitalized due to peritonitis.Attempts to obtain additional information with the acute dialysis clinic were unsuccessful.Follow-up with the patient cannot be completed as there was no patient name or identifying demographics provided.

Manufacturer Narrative

Plant investigation: the sample was not returned to the manufacturer and a lot number was not provided.A shipping history search was performed to identify the lot numbers for all liberty cycler sets shipped to this account.However, no results were found for a three (3) month time frame immediately preceding the event occurrence date.Therefore, a manufacturing review could not be performed, and an investigation of the device history records (dhr) could not be conducted.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

A hospital registered nurse (rn) contacted fresenius technical support for a patient line blocked alarm received during treatment on a liberty select cycler.The rn stated that they did not add heparin and the patient normally uses heparin when performing treatment at home.Upon follow-up with the rn, they stated they could not remember the patient¿s name but believed they were hospitalized due to peritonitis.Attempts to obtain additional information with the acute dialysis clinic were unsuccessful.Follow-up with the patient cannot be completed as there was no patient name or identifying demographics provided.

• 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
• 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: 19160435
• MDR Text Key: 340797050
• Report Number: 0008030665-2024-00390
• Device Sequence Number: 1
• Product Code: FKX
• UDI-Device Identifier: 00840861100750
• UDI-Public: 00840861100750
• 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: Health Professional,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 05/02/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/22/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: 050-87216
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Date Manufacturer Received: 04/24/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Required Intervention; Hospitalization
• Patient Sex: Male