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 Fatigue (1849); Peritonitis (2252)

Event Date 09/01/2023

Event Type  Injury  

Manufacturer Narrative

The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.  clinical review: a temporal relationship exists between ccpd therapy utilizing the liberty cycler set and the adverse event of peritonitis, characterized by generalized weakness and fatigue.It is well established that pd patients are at high risk for infections of the peritoneum.The root cause of this patient¿s adverse event can be attributed to touch contamination during pd therapy as reported by a medical professional.Nonadherence to aseptic technique through though contamination is the leading source of transmission of peritonitis causing pathogens.This is further evidenced by the presence of a microorganism that is widespread in the environment, such as this case where the patient provided a vehicle for this pathogen while gardening.Therefore, the liberty cycler set can be excluded as a root cause or contributor to this patient¿s adverse event.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, this peritoneal dialysis (pd) patient on continuous cyclic pd (ccpd) therapy on the liberty select cycler reported to fresenius customer service she experienced 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 the patient¿s pd registered nurse, it was reported this patient was hospitalized on (b)(6) 2023 following generalized weakness, fatigue and cloudy peritoneal effluent fluid.Peritoneal effluent fluid cultures and a white blood cell (wbc) count taken in the hospital on (b)(6) 2023 presented with aspergillus (species not reported) in the culture and a wbc count of approximately 2500/ml.The patient was diagnosed with peritonitis due to touch contamination during ccpd therapy on the liberty select cycler at home.It was explained the patient was exposed to this peritonitis causing pathogen while gardening and she contaminated her pd catheter during the following pd treatment.The patient was initially given intraperitoneal (ip) vancomycin and ip ceftazidime (dosages and frequency unknown) for antibiotic therapy, as well as other fungicide medications (types, routes, dosages, and frequency unknown) during this admission.The patient was able to undergo ccpd therapy on a hospital provided baxter cycler (not a fresenius product) until her pd catheter (not a fresenius product) was removed due to the severity and nature of this infection.The patient was transitioned to hemodialysis (hd) for renal replacement therapy on a hospital provided hd device (unknown brand and model) for the duration of the admission.The patient has experienced a difficult hospital course as she is on immunosuppressive therapy following a kidney transplant in (b)(6) 2023, which has complicated this infection and promoted sepsis.The patient is recovering from this event while awaiting discharge home.It was confirmed the patient¿s peritonitis, and the associated hospitalization were not due to a deficiency or malfunction of any fresenius product(s) or device(s).The patient plans to continue hd therapy on an in-center basis upon discharge.

Event Description

On (b)(6) 2023, this peritoneal dialysis (pd) patient on continuous cyclic pd (ccpd) therapy on the liberty select cycler reported to fresenius customer service she experienced 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 the patient¿s pd registered nurse, it was reported this patient was hospitalized on (b)(6) 2023 following generalized weakness, fatigue and cloudy peritoneal effluent fluid.Peritoneal effluent fluid cultures and a white blood cell (wbc) count taken in the hospital on (b)(6) 2023 presented with aspergillus (species not reported) in the culture and a wbc count of approximately 2500/ml.The patient was diagnosed with peritonitis due to touch contamination during ccpd therapy on the liberty select cycler at home.It was explained the patient was exposed to this peritonitis causing pathogen while gardening and she contaminated her pd catheter during the following pd treatment.The patient was initially given intraperitoneal (ip) vancomycin and ip ceftazidime (dosages and frequency unknown) for antibiotic therapy, as well as other fungicide medications (types, routes, dosages, and frequency unknown) during this admission.The patient was able to undergo ccpd therapy on a hospital provided baxter cycler (not a fresenius product) until her pd catheter (not a fresenius product) was removed due to the severity and nature of this infection.The patient was transitioned to hemodialysis (hd) for renal replacement therapy on a hospital provided hd device (unknown brand and model) for the duration of the admission.The patient has experienced a difficult hospital course as she is on immunosuppressive therapy following a kidney transplant in (b)(6) 2023, which has complicated this infection and promoted sepsis.The patient is recovering from this event while awaiting discharge home.It was confirmed the patient¿s peritonitis, and the associated hospitalization were not due to a deficiency or malfunction of any fresenius product(s) or device(s).The patient plans to continue hd therapy on an in-center basis upon 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.Based in the complaint description and information provided the reported peritonitis was attributed to a breach in aseptic technique.There is no allegation of cassette malfunction.As there is no allegation related to product manufacture, the complaint is deemed as unconfirmed.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: 17802057
• MDR Text Key: 324110616
• Report Number: 0008030665-2023-00886
• 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
• Report Date: 11/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/22/2023
• 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: 11/16/2023
• 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: DELFLEX PD FLUID; LIBERTY SELECT CYCLER
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 63 YR
• Patient Sex: Female
• Patient Weight: 65 KG