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 Problem No Information (3190)

Event Date 05/02/2020

Event Type  Injury  

Manufacturer Narrative

Clinical review: a temporal relationship exists between ccpd therapy utilizing the liberty cycler set and the patient¿s adverse events of pulling out their pd catheter (not a fresenius product), which resulted in hospitalization and transition to hd therapy.Causality was attributed to the patient stepping on the liberty cycler set tubing while ambulating during their ccpd treatment.Per the pdrn, the events were unrelated to any deficiency or malfunction of a fresenius product(s) or device(s).The pdrn stated it was the patient¿s actions which caused the pd catheter to become dislodged.The fresenius liberty select cycler user guide cautions patients regarding the potential tripping hazard created by the tubing.Based on the information available, the liberty cycler set can be disassociated from the events.There is no allegation or objective evidence indicating a fresenius product deficiency or malfunction caused or contributed to the serious adverse events.The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity. .

Event Description

A patient continuous cyclic peritoneal dialysis (ccpd) for renal replacement therapy (rrt) reported that they were hospitalized after a fall at home.During follow-up, the patient¿s peritoneal dialysis registered nurse (pdrn) reported the patient was walking around their apartment while undergoing continuous cyclic peritoneal dialysis (ccpd), despite numerous warnings about the risk.The patient reportedly stepped on the liberty cycler set tubing and ¿yanked out¿ the pd catheter (not a fresenius product).The pdrn reported the patient fabricated the story of falling to try and coverup why the pd catheter was pulled out.On (b)(6) 2020, the patient presented to the emergency room (er) after skipping pd therapy for 2 days due to the pd catheter being pulled out.There was no fluid overload or dyspnea.The patient is recovering but remains hospitalized and is undergoing hemodialysis (hd) therapy until a possible pd catheter revision can be performed.Per the pdrn, the events were unrelated to any deficiency or malfunction of a fresenius product(s), drug(s) or device(s).The pdrn stated it was the patient¿s actions which caused the pd catheter to become dislodged.

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.

• 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: 10070817
• MDR Text Key: 191452431
• Report Number: 8030665-2020-00658
• 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: company representative,consum
• Type of Report: Initial,Followup
• Report Date: 05/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/19/2020
• 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: 05/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: DELFLEX PD FLUID; LIBERTY SELECT CYCLER; DELFLEX PD FLUID; LIBERTY SELECT CYCLER
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 71 YR
• Patient Weight: 82