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 Problems Peritonitis (2252); Malaise (2359)

Event Date 03/18/2024

Event Type  Injury  

Manufacturer Narrative

Clinical investigation: a temporal relationship exists between the pd therapy with the liberty select cycler and the patient¿s peritonitis event.However, there is no allegation nor any objective evidence that a liberty select cycler malfunction or product deficiency was associated with this event.All pd patients are at risk of peritonitis.The patient had concomitant constipation which is a well-documented risk factor for peritonitis in pd patients.Furthermore, the patient has pre-existing and persistent confusion.Therefore, the patient¿s peritonitis is likely to be associated with concomitant constipation in combination with pre-existing altered mental status due to disease process.The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.

Event Description

A peritoneal dialysis registered nurse (pdrn) reported that the patient was hospitalized on (b)(6) and diagnosed on (b)(6 for peritonitis.Upon additional follow-up, the patient¿s pdrn reported that the patient was hospitalized on (b)(6) 2024 for malaise.During hospitalization, on (b)(6) 2024, the patient had a pd culture obtained which generated an elevated white blood cell (wbc) count.The patient was treated with intravenous (iv) antibiotic therapy using ceftazidime and vancomycin (dose unknown).Per the nurse, it was also discovered that the patient¿s pd catheter (not a fresenius product) had stopped working.As a result, the patient was transitioned to hemodialysis for renal replacement needs.At the time follow-up was performed, the patient remained in the hospital recovering from the event.Per the nurse, the patient did not have any fluid leaks or any issues with fresenius device, or product in relation to the event.The nurse indicated the patient had concomitant constipation.Additionally, the nurse stated the patient has pre-existing and ongoing confusion due to disease process.The nurse reported that the peritonitis event was likely due to patient error (in setting of pre-existing confusion) combined with concomitant constipation.

Event Description

A peritoneal dialysis registered nurse (pdrn) reported that the patient was hospitalized on (b)(6) 2024 and diagnosed on (b)(6) 2024 for peritonitis.Upon additional follow-up, the patient¿s pdrn reported that the patient was hospitalized on (b)(6) 2024 for malaise.During hospitalization, on (b)(6) 2024, the patient had a pd culture obtained which generated an elevated white blood cell (wbc) count.The patient was treated with intravenous (iv) antibiotic therapy using ceftazidime and vancomycin (dose unknown).Per the nurse, it was also discovered that the patient¿s pd catheter (not a fresenius product) had stopped working.As a result, the patient was transitioned to hemodialysis for renal replacement needs.At the time follow-up was performed, the patient remained in the hospital recovering from the event.Per the nurse, the patient did not have any fluid leaks or any issues with fresenius device, or product in relation to the event.The nurse indicated the patient had concomitant constipation.Additionally, the nurse stated the patient has pre-existing and ongoing confusion due to disease process.The nurse reported that the peritonitis event was likely due to patient error (in setting of pre-existing confusion) combined with concomitant constipation.

Manufacturer Narrative

Correction: h6 component code 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.

• 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: 19026754
• MDR Text Key: 339208179
• Report Number: 0008030665-2024-00321
• 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: Health Professional,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 04/12/2024

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Initial Date Manufacturer Received: 03/20/2024
• Initial Date FDA Received: 04/02/2024
• Supplement Dates Manufacturer Received: 04/11/2024
• Supplement Dates FDA Received: 04/12/2024
• 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: 74 YR
• Patient Sex: Female