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

Catalog Number	050-87215
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Abdominal Pain (1685); Peritonitis (2252)
Date of Event	06/29/2024
Type of Reportable Event	Serious Injury
Additional 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 select cycler with the liberty cycler set and the adverse event of peritonitis, characterized by abdominal pain and cloudy effluent.It is well established that pd patients are at high risk for infections of the peritoneum.The cause of this patient¿s infection cannot be determined; however, there was no indication the patient¿s peritonitis and associated hospitalization were due to a deficiency or malfunction of any fresenius product(s) or device(s) as reported by a medical professional.This is further evidenced by the presence of a microorganism that is part of the normal flora of human skin, as well as gastrointestinal (gi) and genitourinary (gu) tracts.Therefore, the liberty select cycler with the liberty cycler set can be excluded as a root cause or contributor to this patient¿s adverse event.Based on the available 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 or Problem Description
On 10/jul/2024, a patient contact reported to fresenius customer service this peritoneal dialysis (pd) patient on continuous cyclic pd (ccpd) therapy utilizing the liberty select cycler experienced an infection and was hospitalized.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.Peritoneal effluent fluid cultures and a white blood cell (wbc) count taken in the hospital on 29/jun/2024 presented with candida parapsilosis in the culture and an elevated wbc count (exact count not reported).The patient was diagnosed with peritonitis due to unknown etiology.The patient was prescribed intraperitoneal vancomycin at 2000 mg every three days for two weeks and oral fluconazole at 200 mg daily for two weeks.The patient¿s pd catheter was removed due to the nature of this fungal infection.The patient received a central vascular catheter in favor of hemodialysis (hd) as the patient was transitioned to hd for renal replacement therapy on a hospital provided hd device for the duration of admission.The patient had an uneventful hospital course and was discharged to home on (b)(6) 2024.It was confirmed, though the exact cause of this patient¿s infection remains unknown, there was no indication the peritonitis and associated hospitalization were due to a deficiency or malfunction of any fresenius product(s) or device(s).The patient recovered from this event as he remains on hd therapy on an in-center basis post-discharge, and he plans to return to pd therapy on the same liberty select cycler.
Additional 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 or Problem Description
On (b)(6) 2024, a patient contact reported to fresenius customer service this peritoneal dialysis (pd) patient on continuous cyclic pd (ccpd) therapy utilizing the liberty select cycler experienced an infection and was hospitalized.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.Peritoneal effluent fluid cultures and a white blood cell (wbc) count taken in the hospital on (b)(6) 2024 presented with candida parapsilosis in the culture and an elevated wbc count (exact count not reported).The patient was diagnosed with peritonitis due to unknown etiology.The patient was prescribed intraperitoneal vancomycin at 2000 mg every three days for two weeks and oral fluconazole at 200 mg daily for two weeks.The patient¿s pd catheter was removed due to the nature of this fungal infection.The patient received a central vascular catheter in favor of hemodialysis (hd) as the patient was transitioned to hd for renal replacement therapy on a hospital provided hd device for the duration of admission.The patient had an uneventful hospital course and was discharged to home on (b)(6) 2024.It was confirmed, though the exact cause of this patient¿s infection remains unknown, there was no indication the peritonitis and associated hospitalization were due to a deficiency or malfunction of any fresenius product(s) or device(s).The patient recovered from this event as he remains on hd therapy on an in-center basis post-discharge, and he plans to return to pd therapy on the same liberty select cycler.
Event or Problem Description
On (b)(6)2024, a patient contact reported to fresenius customer service this peritoneal dialysis (pd) patient on continuous cyclic pd (ccpd) therapy utilizing the liberty select cycler experienced an infection and was hospitalized.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.Peritoneal effluent fluid cultures and a white blood cell (wbc) count taken in the hospital on (b)(6) 2024 presented with candida parapsilosis in the culture and an elevated wbc count (exact count not reported).The patient was diagnosed with peritonitis due to unknown etiology.The patient was prescribed intraperitoneal vancomycin at 2000 mg every three days for two weeks and oral fluconazole at 200 mg daily for two weeks.The patient¿s pd catheter was removed due to the nature of this fungal infection.The patient received a central vascular catheter in favor of hemodialysis (hd) as the patient was transitioned to hd for renal replacement therapy on a hospital provided hd device for the duration of admission.The patient had an uneventful hospital course and was discharged to home on (b)(6) 2024.It was confirmed, though the exact cause of this patient¿s infection remains unknown, there was no indication the peritonitis and associated hospitalization were due to a deficiency or malfunction of any fresenius product(s) or device(s).The patient recovered from this event as he remains on hd therapy on an in-center basis post-discharge, and he plans to return to pd therapy on the same liberty select cycler.
Additional Manufacturer Narrative
Correction provided in g2.

• Brand Name: LIBERTY CYCLER SET, SINGLE PATIENT CONN
• Common Device Name: 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: 19794555
• Report Number: 0008030665-2024-00641
• Device Sequence Number: 19869771
• Product Code: FKX
• UDI-Device Identifier: 00840861100743
• UDI-Public: 00840861100743
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K173718
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/09/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Catalogue Number: 050-87215
• Was Device Available for Evaluation?: No
• Device Age: MO
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/10/2024
• Supplement Date Received by Manufacturer: 07/30/2024; 08/08/2024
• Initial Report FDA Received Date: 07/22/2024
• Supplement Report FDA Received Date: 07/31/2024; 08/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: DELFLEX PD FLUID; DELFLEX PD FLUID; DELFLEX PD FLUID; LIBERTY SELECT CYCLER; LIBERTY SELECT CYCLER; LIBERTY SELECT CYCLER
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 67 YR
• Patient Sex: Male
• Patient Weight: 64 KG