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 02/25/2024

Event Type  Injury  

Manufacturer Narrative

Clinical review: a temporal relationship exists between the pd therapy with the liberty cycler set and the patient¿s peritonitis event.Currently, there is no allegation nor any objective evidence that a liberty cycler set malfunction or product deficiency was associated with this event.Peritonitis is a well-documented complication in patients undergoing pd therapy.Based on the reported information, the patient¿s peritonitis was associated with a breach in aseptic technique during the pd exchange (a known risk factor), according to the pd nurse.The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.

Event Description

A nurse reported a patient on peritoneal dialysis (pd) therapy was hospitalized for peritonitis.There were no reported allegations that the event was related to fresenius products.In additional follow-up, the patient¿s pd nurse reported that on (b)(6) 2024 the patient was hospitalized with symptoms of abdominal pain.During hospitalization.The patient had a pd culture obtained which yielded an elevated white blood cell (wbc) count and no organism growth.The patient was initiated on intra-peritoneal (ip) antibiotic therapy with vancomycin and ceftazidime (dosing not provided).On (b)(6) 2024, the patient was discharged and is reportedly recovering from peritonitis event.The patient continues pd with the same cycler, per the nurse.The nurse stated the patient did not have any fluid leaks or any issues with fresenius products in relation to the event.The nurse stated the peritonitis was due to a breach in aseptic technique during the pd exchange.

Event Description

A nurse reported a patient on peritoneal dialysis (pd) therapy was hospitalized for peritonitis.There were no reported allegations that the event was related to fresenius products.In additional follow-up, the patient¿s pd nurse reported that on (b)(6)2024 the patient was hospitalized with symptoms of abdominal pain.During hospitalization.The patient had a pd culture obtained which yielded an elevated white blood cell (wbc) count and no organism growth.The patient was initiated on intra-peritoneal (ip) antibiotic therapy with vancomycin and ceftazidime (dosing not provided).On (b)(6) 2024, the patient was discharged and is reportedly recovering from peritonitis event.The patient continues pd with the same cycler, per the nurse.The nurse stated the patient did not have any fluid leaks or any issues with fresenius products in relation to the event.The nurse stated the peritonitis was due to a breach in aseptic technique during the pd exchange.

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.

• 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: 18913446
• MDR Text Key: 337773588
• Report Number: 0008030665-2024-00273
• 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: 03/28/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: 050-87216
• Device Lot Number: 23KR08052
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Date Manufacturer Received: 03/21/2024
• 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 Age: 42 YR
• Patient Sex: Male