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 Peritonitis (2252); Fungal Infection (2419)

Event Date 03/15/2024

Event Type  Injury  

Event Description

On 22/mar/2024, fresenius became aware this patient with end stage renal disease (esrd) on continuous cyclic peritoneal dialysis [cc(pd)] utilizing a liberty select cycler and liberty cycler set for renal replacement therapy (rrt) was hospitalized due to hypotension, shortness of breath (dyspnea), and confusion.No additional information was provided during intake.During follow-up, the patient¿s pd registered nurse (pdrn) confirmed the patient presented to the outpatient home dialysis clinic on (b)(6) 2024 for his monthly appointment with his nephrologist.While checking the patient in, it was noted the patient was hypotensive, confused, and dyspneic.The patient was sent to the emergency room from the outpatient dialysis clinic via emergency medical services.The patient was admitted for chronic obstructive pulmonary disease (copd) exacerbation due to asthma and was successfully treated with steroids (confusion and dyspnea abated).While admitted it was noted the patient¿s peritoneal effluent fluid was cloudy on (b)(6) 2024, and a peritoneal effluent fluid culture and cell count (wbc = elevated, value unknown) were collected.The patient was subsequently diagnosed with peritonitis and was treated with intraperitoneal (ip) vancomycin 1500 mg and ceftazidime 1500 mg daily.However, on (b)(6) 2024 the preliminary peritoneal effluent fluid cultures were positive for candida (genus unknown) and the attending nephrologist ordered the removal of the patient¿s pd catheter, while simultaneously receiving a tunneled hemodialysis (hd) catheter (not a fresenius product).The patient¿s antibiotic regimen remains unchanged; however, it is now being administered intravenously (iv) during hd therapy.The pdrn attributed causality to the patient wearing his cpap mask instead of a ¿yellow¿ mask causing air to blow directly at the pd catheter (not a fresenius product) during initiation and termination of treatment.Per the pdrn, the events were unrelated to the patient¿s utilization of any fresenius product(s) and/or device(s).The pdrn stated the patient¿s hypotension resolved without any direct medical intervention once the patient¿s peritonitis, asthma, and copd exacerbation were treated.The patient currently remains hospitalized and is recovering from the serious adverse events.

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, liberty cycler set and the adverse events of fungal peritonitis, which warranted hospitalization and the patient¿s transition to hd for rrt.The pdrn reported the patient¿s copd exacerbation was the result of his chronic asthma, and the fungal peritonitis was caused by the patient wearing his cpap mask instead of a yellow mask during initiation and termination of treatment which caused air to blow directly at the pd catheter (not a fresenius product).Per the pdrn, the serious adverse events were unrelated to the patient¿s utilization of any fresenius device(s) and/or product(s).The patient approximately 1-15% of all peritonitis cases are fungal in nature, and frequently require the removal of the patient¿s pd catheter.Based on the information available, the liberty select cycler and liberty cycler set can be disassociated from the events.There is no allegation or objective evidence indicating a fresenius device(s) and/or product(s) caused or contributed to the serious adverse events.Furthermore, there was no report a fresenius device(s) and/or product(s) failed to meet users¿ expectations or manufacturers¿ specifications.Those individuals undergoing pd therapy (manual or cycler based) are at high risk for infections of the peritoneum.

Event Description

On (b)(6) 2024, fresenius became aware this patient with end stage renal disease (esrd) on continuous cyclic peritoneal dialysis [cc(pd)] utilizing a liberty select cycler and liberty cycler set for renal replacement therapy (rrt) was hospitalized due to hypotension, shortness of breath (dyspnea), and confusion.No additional information was provided during intake.During follow-up, the patient¿s pd registered nurse (pdrn) confirmed the patient presented to the outpatient home dialysis clinic on (b)(6) 2024 for his monthly appointment with his nephrologist.While checking the patient in, it was noted the patient was hypotensive, confused, and dyspneic.The patient was sent to the emergency room from the outpatient dialysis clinic via emergency medical services.The patient was admitted for chronic obstructive pulmonary disease (copd) exacerbation due to asthma and was successfully treated with steroids (confusion and dyspnea abated).While admitted it was noted the patient¿s peritoneal effluent fluid was cloudy on (b)(6) 2024, and a peritoneal effluent fluid culture and cell count (wbc = elevated, value unknown) were collected.The patient was subsequently diagnosed with peritonitis and was treated with intraperitoneal (ip) vancomycin 1500 mg and ceftazidime 1500 mg daily.However, on (b)(6) 2024 the preliminary peritoneal effluent fluid cultures were positive for candida (genus unknown) and the attending nephrologist ordered the removal of the patient¿s pd catheter, while simultaneously receiving a tunneled hemodialysis (hd) catheter (not a fresenius product).The patient¿s antibiotic regimen remains unchanged; however, it is now being administered intravenously (iv) during hd therapy.The pdrn attributed causality to the patient wearing his cpap mask instead of a ¿yellow¿ mask causing air to blow directly at the pd catheter (not a fresenius product) during initiation and termination of treatment.Per the pdrn, the events were unrelated to the patient¿s utilization of any fresenius product(s) and/or device(s).The pdrn stated the patient¿s hypotension resolved without any direct medical intervention once the patient¿s peritonitis, asthma, and copd exacerbation were treated.The patient currently remains hospitalized and is recovering from the serious adverse events.

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.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.

• 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: 19003440
• MDR Text Key: 338900423
• Report Number: 0008030665-2024-00314
• 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: 04/18/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2024
• 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: 04/17/2024
• 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): Required Intervention; Hospitalization
• Patient Age: 87 YR
• Patient Sex: Male
• Patient Weight: 91 KG