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

Model Number 050-87216

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

Patient Problems Anemia (1706); Diarrhea (1811); Unspecified Infection (1930); Uremia (2188)

Event Date 12/02/2020

Event Type  Injury  

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.Clinical review: based on the available information, there was no indication of a serious injury, patient death, or other adverse event related to a fresenius product or other issue warranting further investigation.Additionally, there was no allegation of a liberty select cycler or liberty cycler set malfunction related to the reported event.

Event Description

A peritoneal dialysis (pd) patient reported to fresenius technical support (ts) that they had been hospitalized.Ts followed up with the patient's peritoneal dialysis registered nurse (pdrn) for more information.There was no specific allegation the event was related to a deficiency or malfunction of any fresenius device(s) or product(s) in the initial reporting.Upon additional follow-up, the patient's pdrn revealed the patient was hospitalized for an elevated white blood cell count, anemia, diarrhea and uremic symptoms.It was reported the patient had an infection, yet the nature of the infection and diagnosis were not reported to the outpatient clinic.The patient was ruled out for peritonitis and it was suspected the infection may have been gastrointestinal in nature.The patient was able to undergo ccpd therapy on a hospital provided cycler (brand and model unknown) during the admission.The patient had an uneventful hospital course and was discharged the following day.It was confirmed the patient's symptoms, unspecified infection and the associated hospitalization were unrelated to pd therapy and not due to a deficiency or malfunction of any fresenius product(s) or device(s).The patient continues ccpd therapy on a newly received liberty select cycler at home, post-discharge.

Manufacturer Narrative

Additional information: a2 and a4; this information was omitted from the initial report.

• 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
• MDR Report Key: 11067119
• MDR Text Key: 223791215
• Report Number: 8030665-2020-01877
• Device Sequence Number: 1
• Product Code: FKX
• UDI-Device Identifier: 00840861100750
• UDI-Public: 00840861100750
• Combination Product (y/n): N
• PMA/PMN Number: K043363
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Type of Report: Initial,Followup
• Report Date: 01/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 050-87216
• Device Catalogue Number: 050-87216
• Was Device Available for Evaluation?: No
• Device Age: MO
• Date Manufacturer Received: 01/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: DELFLEX PD FLUID.; LIBERTY SELECT CYCLER.
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 61 YR
• Patient Weight: 90