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 02/02/2024

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.It was reported the patient¿s caregiver was assisting the patient to perform pd therapy and that hand/hygiene with the presence of long fingernails was a concern.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

It was reported that this patient on peritoneal dialysis (pd) therapy had an event of peritonitis.There were no reported allegations that the event was related to any issues with fresenius products.In additional follow-up, the patient¿s pd nurse reported that the patient had peritonitis on 2/feb/2024.The nurse clarified that the patient was seen in the emergency room (er) on 19/mar/2024 for a urinary tract infection (uti) characterized by abdominal pain; unrelated to dialysis/product.With respect to the reported peritonitis, it was stated that on 2/feb/2024 the patient was seen in the outpatient pd clinic with symptoms of abdominal pain.The patient had a pd culture obtained (the same day) which grew the bacteria corynebacterium species.The patient was initiated on intra-peritoneal (ip) antibiotic therapy with vancomycin (per clinic protocol) on an outpatient basis.The patient recovered from the peritonitis event and continued pd with the same cycler.The nurse stated the patient did not have any fluid leaks or any issues with fresenius products in relation to the event.The nurse provided that the patient¿s daughter assists with pd therapy due to the patient having pre-existing dementia.It was stated the caregiver has very long fingernails and that hand hygiene was a concern.Therefore, the nurse stated the peritonitis was due to a breach in aseptic technique during the pd exchange.

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.

Event Description

It was reported that this patient on peritoneal dialysis (pd) therapy had an event of peritonitis.There were no reported allegations that the event was related to any issues with fresenius products.In additional follow-up, the patient¿s pd nurse reported that the patient had peritonitis on (b)(6) 2024.The nurse clarified that the patient was seen in the emergency room (er) on (b)(6) 2024 for a urinary tract infection (uti) characterized by abdominal pain; unrelated to dialysis/product.With respect to the reported peritonitis, it was stated that on (b)(6) 2024 the patient was seen in the outpatient pd clinic with symptoms of abdominal pain.The patient had a pd culture obtained (the same day) which grew the bacteria corynebacterium species.The patient was initiated on intra-peritoneal (ip) antibiotic therapy with vancomycin (per clinic protocol) on an outpatient basis.The patient recovered from the peritonitis event and continued pd with the same cycler.The nurse stated the patient did not have any fluid leaks or any issues with fresenius products in relation to the event.The nurse provided that the patient¿s daughter assists with pd therapy due to the patient having pre-existing dementia.It was stated the caregiver has very long fingernails and that hand hygiene was a concern.Therefore, the nurse stated the peritonitis was due to a breach in aseptic technique during the pd exchange.

• 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: 19177321
• MDR Text Key: 341001517
• Report Number: 0008030665-2024-00400
• 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: Consumer,Health Professional,User Facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 04/24/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/24/2024
• 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: 04/10/2024
• 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: 77 YR
• Patient Sex: Female