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 Problems Abdominal Pain (1685); Peritonitis (2252)

Event Date 03/13/2024

Event Type  Injury  

Manufacturer Narrative

The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.  clinical review: there is a temporal relationship between peritoneal dialysis 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 peritonitis and use of the cycler set.Additionally, there is no allegation of a cycler set defect reported for the event.The cause of the peritonitis was attributed to touch contamination by the patient.This is supported by the culture results of corynebacteria, a species that belongs to the physiological flora of human skin and mucous membranes.Based on the available information and no allegation of a defect, the liberty cycler set can be excluded as the cause of the patient¿s peritonitis event.

Event Description

On (b)(6) 2024 a delivery driver reported that this male peritoneal dialysis (pd) patient was not at home due to being treated for peritonitis at the pd clinic.Additional information was obtained through follow-up with the patient¿s peritoneal dialysis registered nurse (pdrn).The patient was seen at the pd clinic on (b)(6) 2024 for symptoms of abdominal pain and cloudy pd effluent.A pd effluent culture was obtained.The patient was diagnosed with peritonitis and initiated antibiotic therapy with intraperitoneal (ip) vancomycin (dose, frequency, and duration not provided).The pd effluent culture resulted positive on (b)(6) 2024 for corynebacterium species.The patient did not require hospitalization for the event.The cause of the peritonitis was attributed to touch contamination by the patient.The patient is continuing to complete pd therapy utilizing the liberty select cycler during recovery.

Manufacturer Narrative

Correction provided in h3.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.There is no allegation of cassette malfunction based in the complaint description and information provided that the reported peritonitis was attributed to a breach in aseptic technique.There is no allegation of cassette malfunction.As there is no allegation related to product manufacture, the complaint is deemed as unconfirmed.

Event Description

On (b)(6) 2024 a delivery driver reported that this male peritoneal dialysis (pd) patient was not at home due to being treated for peritonitis at the pd clinic.Additional information was obtained through follow-up with the patient¿s peritoneal dialysis registered nurse (pdrn).The patient was seen at the pd clinic on (b)(6) 2024 for symptoms of abdominal pain and cloudy pd effluent.A pd effluent culture was obtained.The patient was diagnosed with peritonitis and initiated antibiotic therapy with intraperitoneal (ip) vancomycin (dose, frequency, and duration not provided).The pd effluent culture resulted positive on (b)(6) 2024 for corynebacterium species.The patient did not require hospitalization for the event.The cause of the peritonitis was attributed to touch contamination by the patient.The patient is continuing to complete pd therapy utilizing the liberty select cycler during recovery.

• 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: 18950785
• MDR Text Key: 338308770
• Report Number: 0008030665-2024-00286
• 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: Other,Health Professional,User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 04/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2024
• 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
• Device Age: MO
• Date Manufacturer Received: 04/11/2024
• 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
• Patient Age: 47 YR
• Patient Sex: Male