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 Peritonitis (2252); Malaise (2359); Constipation (3274)

Event Date 12/20/2023

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 temporal relationship between peritoneal dialysis utilizing the liberty select cycler and liberty cycler set and the patient event of peritonitis with hospitalization.However, there is no documentation to show a causal relationship between the peritonitis event and use of the liberty select cycler and liberty cycler set.Additionally, there is no allegation of a device malfunction or deficiency, or cycler set defect reported for this event.The culture was negative for growth; therefore, the cause of the peritonitis event cannot be confirmed.However, the suspected cause of the peritonitis was reported as constipation.Constipation and diarrhea have been positively correlated with pd-associated peritonitis, suggesting that the presence of diarrhea or constipation increases the risk for pd-associated peritonitis.It has been reported that peritonitis can be caused by transmural migration of intestinal microbes.Furthermore, this patient was new to pd therapy and could have experienced a breach in aseptic technique leading to the peritonitis event.All dialysis patients are at risk of peritonitis due to a compromised immune system and the increase of potential for microbial contamination from dialysis techniques.Based on the available information and no allegation or evidence of a malfunction, deficiency, or defect, the liberty select cycler and liberty cycler set can be excluded as the cause of the patient¿s peritonitis event.

Event Description

During follow-up for an unrelated cycler alarm that occurred during this patient¿s peritoneal dialysis (pd) treatment on 18/dec/2023, it was reported by the patient that they went to the emergency room (er) due to feeling sick.No further details were provided by the patient.Additional follow-up with the patient¿s pd registered nurse (pdrn) confirmed the patient was admitted to the hospital with a diagnosis of peritonitis.The patient was admitted to the hospital on (b)(6) 2023 due to unspecified symptoms and was diagnosed with peritonitis and constipation.A pd effluent culture was obtained.The patient was administered antibiotic therapy with intraperitoneal (ip) vancomycin (dose, frequency, and duration unknown).The patient¿s white blood cell (wbc) count was elevated to 800 (unknown units).The pd cultures resulted negative for growth; however, initially it was thought the peritonitis would be a gram-negative infection based on the patient¿s concomitant constipation.The patient was discharged on (b)(6) 2023 and continues to complete antibiotic therapy during recovery.The patient is reportedly new to pd therapy.The cause of the patient¿s peritonitis could not be determined.

Event Description

During follow-up for an unrelated cycler alarm that occurred during this patient¿s peritoneal dialysis (pd) treatment on (b)(6) 2023, it was reported by the patient that they went to the emergency room (er) due to feeling sick.No further details were provided by the patient.Additional follow-up with the patient¿s pd registered nurse (pdrn) confirmed the patient was admitted to the hospital with a diagnosis of peritonitis.The patient was admitted to the hospital on (b)(6) 2023 due to unspecified symptoms and was diagnosed with peritonitis and constipation.A pd effluent culture was obtained.The patient was administered antibiotic therapy with intraperitoneal (ip) vancomycin (dose, frequency, and duration unknown).The patient¿s white blood cell (wbc) count was elevated to 800 (unknown units).The pd cultures resulted negative for growth; however, initially it was thought the peritonitis would be a gram-negative infection based on the patient¿s concomitant constipation.The patient was discharged on (b)(6) 2023 and continues to complete antibiotic therapy during recovery.The patient is reportedly new to pd therapy.The cause of the patient¿s peritonitis could not be determined.

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.

• 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: 18508521
• MDR Text Key: 332867691
• Report Number: 0008030665-2024-00044
• Device Sequence Number: 1
• Product Code: FKX
• 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,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 02/09/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2024
• 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: 02/06/2024
• 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): Hospitalization; Required Intervention
• Patient Age: 72 YR
• Patient Sex: Female