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

Model Number 050-87212

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

Patient Problems Peritonitis (2252); Malaise (2359)

Event Date 10/06/2021

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 ccpd therapy utilizing the liberty select cycler and liberty cycler set and the adverse events of peritonitis.It is well established pd patients are at high risk for infections of the peritoneum.The source of the patient¿s peritonitis cannot be determined as there was no confirmed source; however, it was confirmed there was no deficiency or malfunction of the patient¿s dialysate solution as reported by a medical professional.Though the source of this infection was unknown, fungal infections involving candida spp.Originate from human skin, gastrointestinal tracts and genitourinary tracts with most transmissions resulting from touch contamination.In the absence of a confirmed source of this event, the liberty select cycler and liberty cycler set cannot be excluded as a root cause or contributor to this event.Based on the available information, there was no allegation or objective evidence any fresenius product(s) or device(s) deficiency or malfunction caused or contributed to this patient¿s adverse event.

Event Description

A peritoneal dialysis nurse (pdrn) for a peritoneal dialysis (pd) patient on continuous cycling peritoneal dialysis (ccpd) for renal replacement therapy (rrt) contacted customer support to report that a patient had peritonitis.Upon follow up, the pdrn stated the patient was hospitalized for peritonitis due to not feeling well (signs and symptoms unknown).The pdrn stated the patient was admitted to the hospital on (b)(6) 2021 and was discharged on (b)(6) 2021 and is fully recovered.The cause of the patient¿s peritonitis was unknown as the patient practices aseptic technique and has not had any reported fluid leaks.The pdrn stated that the patient did have a culture taken which was positive for peritonitis, the culture was taken on (b)(6) 2021 and the culture came back positive for candida polyphemus.The patient was prescribed an antibiotic cocktail of vancomycin (iv, dose of 1.5 grams), fortax (2 grams) and gentamicin (160 mg) as a onetime dose.The pdrn stated that the patient has been switched to hd therapy and has been continuing hd therapy without reoccurrence of the event.Additional details surrounding the patient¿s hospital course and condition were requested, however, not provided.

Manufacturer Narrative

Plant investigation: as the device was not returned to the manufacturer, a physical evaluation could not be performed.A batch records review was conducted by the manufacturer for the reported lot.There were no non-conformances or abnormalities identified during the manufacturing process which could be associated with the reported event.The entire lot has been sold and distributed.In addition, a device history review was performed and confirmed that the results of the in-progress and final quality control (qc) testing met all requirements.The lot met all specifications for release.A product history review 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

A peritoneal dialysis nurse (pdrn) for a peritoneal dialysis (pd) patient on continuous cycling peritoneal dialysis (ccpd) for renal replacement therapy (rrt) contacted customer support to report that a patient had peritonitis.Upon follow up, the pdrn stated the patient was hospitalized for peritonitis due to not feeling well (signs and symptoms unknown).The pdrn stated the patient was admitted to the hospital on (b)(6) 2021 and was discharged on (b)(6) 2021 and is fully recovered.The cause of the patient¿s peritonitis was unknown as the patient practices aseptic technique and has not had any reported fluid leaks.The pdrn stated that the patient did have a culture taken which was positive for peritonitis, the culture was taken on (b)(6) 2021 and the culture came back positive for candida polyphemus.The patient was prescribed an antibiotic cocktail of vancomycin (iv, dose of 1.5 grams), fortax (2 grams) and gentamicin (160 mg) as a onetime dose.The pdrn stated that the patient has been switched to hd therapy and has been continuing hd therapy without reoccurrence of the event.Additional details surrounding the patient¿s hospital course and condition were requested, however, not provided.

• Brand Name: LIBERTY CYCLER SET, DUAL PATIENT CONNECT
• 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
• MDR Report Key: 12705606
• MDR Text Key: 278763450
• Report Number: 8030665-2021-01645
• Device Sequence Number: 1
• Product Code: FKX
• UDI-Device Identifier: 00840861100736
• UDI-Public: 00840861100736
• Combination Product (y/n): N
• PMA/PMN Number: K043363
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 11/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/31/2024
• Device Model Number: 050-87212
• Device Catalogue Number: 050-87212
• Device Lot Number: 21CR08143
• Was Device Available for Evaluation?: No
• Device Age: MO
• Date Manufacturer Received: 10/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• 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: 58 YR
• Patient Weight: 85