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 Abdominal Pain (1685); Peritonitis (2252)

Event Date 03/28/2024

Event Type  Injury  

Event Description

On 11/apr/2024, this peritoneal dialysis (pd) patient on continuous cyclic pd (ccpd) therapy utilizing the liberty select cycler reported to fresenius customer service he experienced peritonitis and was in the hospital.There was no specific allegation this adverse event was related 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) 2024 following abdominal pain and cloudy peritoneal effluent fluid.Laboratory testing conducted in the hospital was not reported to the outpatient clinic and the results remain unknown.The patient was diagnosed with peritonitis due to touch contamination during ccpd therapy at home.The patient was prescribed intraperitoneal (ip) vancomycin at 2000 mg and ip cefepime at 2000 mg (frequency and duration unknown) to address the infection.The patient was able to undergo ccpd therapy on a hospital provided liberty cycler for the duration of the admission.The patient had an uneventful hospital course and was discharged to home on (b)(6) 2024.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 recovered from this event as he remains asymptomatic.The patient continues ccpd therapy on the same liberty select cycler at home post-discharge.

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 abdominal pain.It is well established that pd patients are at high risk for infections of the peritoneum.The cause of this patient¿s infection can be attributed to nonadherence to aseptic technique during ccpd therapy as reported by a medical professional.It is well known the leading source of transmission of peritonitis causing pathogens is through touch contamination during pd therapy.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.

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.There is no allegation of cassette malfunction based in the complaint description and information provided that 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.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 device history review (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 (b)(6) 2024, this peritoneal dialysis (pd) patient on continuous cyclic pd (ccpd) therapy utilizing the liberty select cycler reported to fresenius customer service he experienced peritonitis and was in the hospital.There was no specific allegation this adverse event was related 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) 2024 following abdominal pain and cloudy peritoneal effluent fluid.Laboratory testing conducted in the hospital was not reported to the outpatient clinic and the results remain unknown.The patient was diagnosed with peritonitis due to touch contamination during ccpd therapy at home.The patient was prescribed intraperitoneal (ip) vancomycin at 2000 mg and ip cefepime at 2000 mg (frequency and duration unknown) to address the infection.The patient was able to undergo ccpd therapy on a hospital provided liberty cycler for the duration of the admission.The patient had an uneventful hospital course and was discharged to home on (b)(6) 2024.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 recovered from this event as he remains asymptomatic.The patient continues ccpd therapy on the same liberty select cycler at home post-discharge.

• 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: 19137108
• MDR Text Key: 340562634
• Report Number: 0008030665-2024-00375
• 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
• Report Date: 04/18/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/18/2024
• 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
• Device Age: MO
• Date Manufacturer Received: 04/11/2024
• 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: 57 YR
• Patient Sex: Male
• Patient Weight: 108 KG