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 Fatigue (1849); Fever (1858); Peritonitis (2252); Discomfort (2330)

Event Date 07/21/2021

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 cycler set and the adverse event of peritonitis, characterized by abdominal discomfort, fatigue and fever.It is well established pd patients are at high risk for infections of the peritoneum.The patient¿s peritonitis can be directly attributed to touch contamination as reported by a medical professional.Poor aseptic technique or ¿touch contamination¿ is the leading source of the transmission of peritonitis causing pathogens.Though the peritoneal effluent fluid cultures remain unknown, the patient¿s symptoms and responsiveness to antibiotic therapy are evidence of a peritonitis infection that was found to be caused by touch contamination.Therefore, the liberty cycler set can be excluded as the root cause of this infection.Based on the required 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 (pd) patient on continuous cyclic pd (ccpd) therapy on the liberty select cycler reported to fresenius technical services (ts) that they were hospitalized.Upon follow up with the patient¿s pd registered nurse (pdrn), it was reported the patient presented to the outpatient clinic on (b)(6) 2021 with abdominal discomfort, fatigue, fever and cloudy peritoneal effluent fluid.The patient was advised to reported to the emergency department (ed) as the patient is allergic to vancomycin and the outpatient clinic did not have the appropriate alternative antibiotic.The patient presented to the ed on the same day when a peritoneal effluent fluid culture and a white blood cell (wbc) count were taken; however, the hospital did not report the results to the outpatient clinic.The patient was diagnosed with peritonitis due to touch contamination during ccpd therapy on the liberty select cycler at home.The patient was held in the ed for 24 hours and admitted to the hospital on (b)(6) 2021.During the admission, the patient was prescribed intraperitoneal daptomycin at 250 mg every day for three weeks.The patient was able to undergo ccpd therapy on a hospital provided baxter cycler and products (not fresenius products) for the duration of the admission.The patient had an uneventful hospital course and was discharged to home on (b)(6) 2021.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 pdrn stated the patient is recovering from this event and continues ccpd therapy on the same liberty select cycler at home.

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.The user guide p/n (b)(4) was reviewed and indicates "you must use aseptic technique as directed by your pd nurse to prevent infection¿.As per the follow up information received, the incident was attributed to end user error.Since the complaint sample was not available for evaluation, the alleged event could not be confirmed.

Event Description

A peritoneal dialysis (pd) patient on continuous cyclic pd (ccpd) therapy on the liberty select cycler reported to fresenius technical services (ts) that they were hospitalized.Upon follow up with the patient¿s pd registered nurse (pdrn), it was reported the patient presented to the outpatient clinic on (b)(6) 2021 with abdominal discomfort, fatigue, fever and cloudy peritoneal effluent fluid.The patient was advised to reported to the emergency department (ed) as the patient is allergic to vancomycin and the outpatient clinic did not have the appropriate alternative antibiotic.The patient presented to the ed on the same day when a peritoneal effluent fluid culture and a white blood cell (wbc) count were taken; however, the hospital did not report the results to the outpatient clinic.The patient was diagnosed with peritonitis due to touch contamination during ccpd therapy on the liberty select cycler at home.The patient was held in the ed for 24 hours and admitted to the hospital on (b)(6) 2021.During the admission, the patient was prescribed intraperitoneal daptomycin at 250 mg every day for three weeks.The patient was able to undergo ccpd therapy on a hospital provided baxter cycler and products (not fresenius products) for the duration of the admission.The patient had an uneventful hospital course and was discharged to home on (b)(6) 2021.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 pdrn stated the patient is recovering from this event and continues ccpd therapy on the same liberty select cycler at home.

• 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: 12274894
• MDR Text Key: 265150186
• Report Number: 8030665-2021-01253
• 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: company representative,consum
• Type of Report: Initial,Followup
• Report Date: 08/23/2021

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
• Device Operator: Lay User/Patient
• Device Model Number: 050-87212
• Device Catalogue Number: 050-87212
• Was Device Available for Evaluation?: No
• Device Age: MO
• Initial Date Manufacturer Received: 07/27/2021
• Initial Date FDA Received: 08/04/2021
• Supplement Dates Manufacturer Received: 08/10/2021
• Supplement Dates FDA Received: 08/22/2021
• 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: 65 YR
• Patient Weight: 65