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

Model Number LIBERTY CYCLER SET, DUAL PATIENT CONNECT

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

Patient Problems Uremia (2188); Peritonitis (2252)

Event Date 11/09/2018

Event Type  Injury  

Manufacturer Narrative

Clinical review: a clinical investigation was performed.A temporal relationship between the patient¿s hospitalization for metabolic encephalopathy due to uremia and peritonitis and the liberty select cycler/liberty cycler set exists.However, there is no objective evidence which indicates the peritonitis or uremia was caused by a liberty select cycler/liberty cycler set malfunction or product deficiency.The patient¿s uremia is most likely associated with a short-prescribed dwell time, as reported by the pd nurse, the patient¿s pd prescription was adjusted and the patient has since recovered.Peritonitis is a well-documented complication known to occur in pd therapy.At this time, it is unknown what exactly caused the patient¿s peritonitis event.Should additional information become available this clinical investigation will be updated accordingly.The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.

Event Description

A peritoneal dialysis registered nurse (pdrn) contacted fresenius technical support to report the liberty select cycler is draining slowly during drain 1.The pdrn stated the patient was submitted to the hospital this morning.Upon follow up, pdrn confirmed that the patient was hospitalized from (b)(6) with a diagnosis of toxic metabolic encephalopathy believed to be due to uremia and peritonitis.The pdrn stated that the patient was uremic and believed it to be due to the patient not receiving sufficient dialysis as he had shorter dwell time.The patient is however complaint to dialysis and did not miss his treatments.Additionally, the patient had peritonitis with elevated white blood cell of 25000 though the pd fluid cultures and blood cultures were negative for growth.The patient was placed on vancomycin and ciprofloxacin.Pd prescription was changed in the hospital from treatment based to cycle based with longer dwells.The patient's number of exchanges and fill volume remained the same at 4 exchanges with 2500ml, last fill volume of 2000ml and a day time exchange with 2000ml.The pdrn attributed the events to the patient having shorter dwell time.The patient has continued pd therapy without issues since discharge on longer dwells and has recovered from the aforementioned events.

Manufacturer Narrative

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.

• 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: 8102910
• MDR Text Key: 128310856
• Report Number: 8030665-2018-01865
• 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,health
• Type of Report: Initial,Followup
• Report Date: 11/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/26/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: LIBERTY CYCLER SET, DUAL PATIENT CONNECT
• Device Catalogue Number: 050-87212
• Was Device Available for Evaluation?: No
• Device Age: MO
• Date Manufacturer Received: 11/28/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: DELFLEX PD FLUID; LIBERTY CYCLER; DELFLEX PD FLUID; LIBERTY CYCLER
• Patient Outcome(s): Hospitalization
• Patient Age: 69 YR