MAUDE Adverse Event Report: CONCORD MANUFACTURING LIBERTY SELECT CYCLER ASSY(NON-VALUATED); SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

Catalog Number RTLR180343

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

Patient Problems Cardiac Arrest (1762); Chest Pain (1776); Death (1802)

Event Date 07/02/2018

Event Type  Death  

Manufacturer Narrative

Clinical investigation: a temporal relationship exists between continuous cyclic peritoneal dialysis (ccpd) therapy utilizing the liberty select cycler and the patient¿s adverse event(s) of chest pain which warranted hospitalization, and the subsequent cardiac arrest and death of the patient.The etiology of the event(s) is unknown; therefore causality cannot fully be determined.The liberty select cycler was not returned for product evaluation.It is known that end stage renal disease (esrd) patients have a higher mortality rating compared to the general population.Additionally, sudden death and cardiac arrhythmias account for 37% of all deaths in the medicare esrd population.At the time of this investigation, there is no allegation or evidence of a machine malfunction or of the machine failing to perform as expected in relation to the event(s).Plant investigation: no parts were returned to the manufacturer for physical evaluation.A records review was performed on the reported serial number.An investigation of the device manufacturing records was conducted by the manufacturer.There were no non-conformances, or any associated rework identified during the manufacturing process which could be related to the reported event.In addition, the device history record (dhr) review confirmed the results of the in-progress and final quality control (qc) testing met all requirements.The investigation into the cause of the reported problem was not able to be confirmed.A definitive conclusion regarding the complaint incident cannot be reached without a physical examination of the complaint device.

Event Description

It was reported that a peritoneal dialysis (pd) patient expired on (b)(6) 2018.Upon follow up with the peritoneal dialysis nurse (pdrn), it was reported that the patient¿s death was due to cardiac arrest (details unknown).The patient reportedly experienced chest pain (details unknown) prior to being transported to the hospital where they expired (details unknown).It is unknown whether the patient was connected to the liberty select cycler when they experienced the chest pain; however the death was reportedly unrelated to the patient¿s renal replacement therapy (rrt).Subsequent attempts to obtain additional information have thus far proven unsuccessful.As such, the hospital course and specifics regarding the patient¿s death are unknown.Furthermore, it is unknown if any fresenius device(s) or product(s) were utilized during the course of hospitalization.The liberty select cycler was not returned to the manufacture for product evaluation.

• Brand Name: LIBERTY SELECT CYCLER ASSY(NON-VALUATED)
• Type of Device: SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
• Manufacturer (Section D): CONCORD MANUFACTURING; 4040 nelson avenue; concord CA 94520
• Manufacturer (Section G): CONCORD MANUFACTURING; 4040 nelson avenue; concord CA 94520
• Manufacturer Contact: thomas c. johnson ; 920 winter st.; waltham, MA 02451 ; 7816999499
• MDR Report Key: 7709817
• MDR Text Key: 114677866
• Report Number: 2937457-2018-02070
• Device Sequence Number: 1
• Product Code: FKX
• UDI-Device Identifier: 00840861102068
• UDI-Public: 00840861102068
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K171652
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 07/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: RTLR180343
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Initial Date Manufacturer Received: 07/03/2018
• Initial Date FDA Received: 07/23/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/29/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Hospitalization
• Patient Age: 81 YR