MAUDE Adverse Event Report: ERIKA DE REYNOSA, S.A. DE C.V. FMC CASSETTE; SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

Model Number 050-87216

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Abdominal Pain (1685); Fatigue (1849); Fever (1858); Sepsis (2067); Peritonitis (2252)

Event Date 03/01/2023

Event Type  Injury  

Manufacturer Narrative

The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.  clinical investigation: a temporal relationship exists between continuous cyclic peritoneal dialysis (ccpd) therapy utilizing the liberty cycler set and the adverse event of peritonitis, characterized by abdominal pain, fever and weakness.It is well established that pd patients are at high risk for infections of the peritoneum.The root cause of this patient¿s peritonitis can be attributed to non-adherence to aseptic technique during ccpd therapy as reported by the patient.Non-adherence to aseptic technique through touch contamination is the leading source of transmission of peritonitis causing pathogens.Additionally, there was no indication the patient¿s sepsis shared a causal relationship to the peritonitis infection.Regardless, it was confirmed the patient¿s sepsis was not due to the performance of any fresenius product(s) and/or device(s).Therefore, the liberty cycler set can be excluded as a root cause or contributor to this patient¿s infections.Based on the required information, there was no allegation or objective evidence of any fresenius product(s) or device(s) deficiency or malfunction caused or contributed to this patient¿s adverse event.

Event Description

On (b)(6) 2023, during a follow up, a patient contact reported to fresenius this peritoneal dialysis (pd) patient on continuous cyclic pd (ccpd) therapy on the liberty select cycler was hospitalized for septic issues and peritonitis.There was no specific allegation this adverse event was due to a deficiency or malfunction of any fresenius product(s) or device(s) in the initial reporting.Upon follow up with this pd patient, it was reported they were hospitalized in the middle of (b)(6) 2023 (exact date of admission unknown) following abdominal pain, fever and weakness.Laboratory tests conducted in the hospital (exact date and lab results unknown) showed that they were septic, and they had peritonitis.It was unknown if the patient¿s peritonitis and sepsis diagnoses were related; however, it was believed they experienced the peritonitis infection prior to experiencing sepsis.The patient contracted peritonitis by being careless during a pd treatment on the liberty select cycler at home where they contaminated the patient line with their bare hands.Any medications prescribed to the patient during this hospitalization to address his sepsis or peritonitis were unable to be recalled.The patient was able to undergo ccpd therapy on a hospital provided cycler (brand and model unknown) for the duration of the admission.The patient had a difficult hospital course involving an intensive care unit admission, but they were discharged to home approximately one week prior to the final follow up (exact date of discharge unknown).It was confirmed the patient¿s sepsis, peritonitis infection, and the associated hospitalization were not due to a deficiency or malfunction of any fresenius product(s) or device(s).The patient continues ccpd therapy on the same liberty select cycler at home post-discharge.

Event Description

On 30/mar/2023, during a follow up, a patient contact reported to fresenius this peritoneal dialysis (pd) patient on continuous cyclic pd (ccpd) therapy on the liberty select cycler was hospitalized for septic issues and peritonitis.There was no specific allegation this adverse event was due to a deficiency or malfunction of any fresenius product(s) or device(s) in the initial reporting.Upon follow up with this pd patient, it was reported they were hospitalized in the (b)(6) 2023 (exact date of admission unknown) following abdominal pain, fever and weakness.Laboratory tests conducted in the hospital (exact date and lab results unknown) showed that they were septic, and they had peritonitis.It was unknown if the patient¿s peritonitis and sepsis diagnoses were related; however, it was believed they experienced the peritonitis infection prior to experiencing sepsis.The patient contracted peritonitis by being careless during a pd treatment on the liberty select cycler at home where they contaminated the patient line with their bare hands.Any medications prescribed to the patient during this hospitalization to address his sepsis or peritonitis were unable to be recalled.The patient was able to undergo ccpd therapy on a hospital provided cycler (brand and model unknown) for the duration of the admission.The patient had a difficult hospital course involving an intensive care unit admission, but they were discharged to home approximately one week prior to the final follow up (exact date of discharge unknown).It was confirmed the patient¿s sepsis, peritonitis infection, and the associated hospitalization were not due to a deficiency or malfunction of any fresenius product(s) or device(s).The patient continues ccpd therapy on the same liberty select cycler at home post-discharge.

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

On 30/mar/2023, during a follow up, a patient contact reported to fresenius this peritoneal dialysis (pd) patient on continuous cyclic pd (ccpd) therapy on the liberty select cycler was hospitalized for septic issues and peritonitis.There was no specific allegation this adverse event was due to a deficiency or malfunction of any fresenius product(s) or device(s) in the initial reporting.Upon follow up with this pd patient, it was reported they were hospitalized in the (b)(6) 2023 (exact date of admission unknown) following abdominal pain, fever and weakness.Laboratory tests conducted in the hospital (exact date and lab results unknown) showed that they were septic, and they had peritonitis.It was unknown if the patient¿s peritonitis and sepsis diagnoses were related; however, it was believed they experienced the peritonitis infection prior to experiencing sepsis.The patient contracted peritonitis by being careless during a pd treatment on the liberty select cycler at home where they contaminated the patient line with their bare hands.Any medications prescribed to the patient during this hospitalization to address his sepsis or peritonitis were unable to be recalled.The patient was able to undergo ccpd therapy on a hospital provided cycler (brand and model unknown) for the duration of the admission.The patient had a difficult hospital course involving an intensive care unit admission, but they were discharged to home approximately one week prior to the final follow up (exact date of discharge unknown).It was confirmed the patient¿s sepsis, peritonitis infection, and the associated hospitalization were not due to a deficiency or malfunction of any fresenius product(s) or device(s).The patient continues ccpd therapy on the same liberty select cycler at home post-discharge.

• Brand Name: FMC CASSETTE
• 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: 16752627
• MDR Text Key: 313428189
• Report Number: 0008030665-2023-00363
• 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,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 05/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/17/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 050-87216
• Device Catalogue Number: UNKNOWN- FMC CASSETTE
• Was Device Available for Evaluation?: No
• Device Age: MO
• Date Manufacturer Received: 05/09/2023
• 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: DEFLEX PD FLUID; DEFLEX PD FLUID; DEFLEX PD FLUID; LIBERTY SELECT CYCLER; LIBERTY SELECT CYCLER; LIBERTY SELECT CYCLER
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 76 YR
• Patient Sex: Male
• Patient Weight: 77 KG