MAUDE Adverse Event Report: ERIKA DE REYNOSA, S.A. DE C.V. LIBERTY CYCLER SET, SINGLE CONN./EXT. DL; SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

Model Number 050-87216

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

Patient Problems Sepsis (2067); Peritonitis (2252); Malaise (2359)

Event Date 06/16/2022

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 (pd) therapy utilizing the liberty select cycler with cycler set and the patient event of peritonitis complicated by sepsis and subsequent death.However, there is no documentation in the complaint file to show a causal relationship between the use of the liberty select cycler with cycler set and the adverse event.Additionally, there is no allegation of a device malfunction or deficiency, or cycler set defect reported for this event.The cause of the patient¿s peritonitis is unknown.All dialysis treatments include risk of infection due to the compromised immune system of the patients and dialysis techniques increasing the potential for microbial contamination.Infection is the second leading cause of death in patients with end stage renal disease (esrd) in which septicemia accounts for 75% of this category.This patient population is considered at high-risk for the development of lethal sepsis.There is no documentation stating that the patient sought medical intervention for the peritonitis prior to being admitted to the hospital with sepsis.It is also unknown if the patient had underlying comorbid conditions that contributed to the death.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 with subsequent sepsis and death.

Event Description

On (b)(6) 2022 a contact for this female peritoneal dialysis (pd) patient reported that the patient passed away.Additional information was obtained through follow-up with the patient¿s peritoneal dialysis registered nurse (pdrn).The patient was in active pd treatment on the liberty select cycler on (b)(6) 2022 when they began not feeling well (unspecified).The patient was transported to the hospital and admitted for sepsis related to peritonitis.During the hospitalization, the pd catheter was pulled.The patient passed away in the hospital on (b)(6) 2022.The cause of the peritonitis is unknown.No further information related to the hospitalization, peritonitis, or death were available.

Event Description

On (b)(6) 2022 a contact for this female peritoneal dialysis (pd) patient reported that the patient passed away.Additional information was obtained through follow-up with the patient¿s peritoneal dialysis registered nurse (pdrn).The patient was in active pd treatment on the liberty select cycler on (b)(6) 2022 when they began not feeling well (unspecified).The patient was transported to the hospital and admitted for sepsis related to peritonitis.During the hospitalization, the pd catheter was pulled.The patient passed away in the hospital on (b)(6) 2022.The cause of the peritonitis is unknown.It was confirmed that the patient passed away from complications of the infection.No further information related to the hospitalization, peritonitis, or death were available.

Manufacturer Narrative

Correction: b5.

Event Description

On (b)(6) 2022 a contact for this female peritoneal dialysis (pd) patient reported that the patient passed away.Additional information was obtained through follow-up with the patient¿s peritoneal dialysis registered nurse (pdrn).The patient was in active pd treatment on the liberty select cycler on (b)(6) 2022 when they began not feeling well (unspecified).The patient was transported to the hospital and admitted for sepsis related to peritonitis.During the hospitalization, the pd catheter was pulled.The patient passed away in the hospital on (b)(6) 2022.The cause of the peritonitis is unknown.It was confirmed that the patient passed away from complications of the infection.No further information related to the hospitalization, peritonitis, or death were available.

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; 1100 e, military hwy, suite c; pharr TX 78577
• Manufacturer Contact: jessica trujillo ; 920 winter st; waltham, MA 02451 ; 6174175172
• MDR Report Key: 15143374
• MDR Text Key: 297038857
• Report Number: 0008030665-2022-00896
• 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: 09/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/02/2022
• 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: 050-87216
• Was Device Available for Evaluation?: No
• Device Age: MO
• Date Manufacturer Received: 09/07/2022
• 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; DELFLEX PD FLUID; LIBERTY SELECT CYCLER; LIBERTY SELECT CYCLER; LIBERTY SELECT CYCLER
• Patient Outcome(s): Hospitalization
• Patient Age: 75 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic