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 Chest Pain (1776); Swelling (2091); Hypervolemia (2664)

Event Date 06/09/2019

Event Type  Injury  

Manufacturer Narrative

Plant investigation: the actual device was returned to the manufacturer for physical evaluation.An external and internal visual inspection was performed and it was observed that the device has insect infestation.The load cell verification test failed due to load cell out of specification.A review of the device manufacturing records was conducted by the manufacturer.There were no deviations or non-conformances during the manufacturing process.In addition, a device history record (dhr) review was performed and verified that the results of the in-progress and final quality control (qc) testing met all requirements.Upon completion of the evaluation, there were no malfunctions that could have caused or contributed to the reported event.The cycler performed as designed and an associated cause could not be determined.Clinical investigation: a temporal relationship does not exist between pd therapy utilizing the liberty select cycler, and the patient¿s hospitalization for fluid overload (fo) or chest pain (cp); as the patient was not utilizing the liberty select cycler prior to the hospitalization.Therefore, the liberty select cycler is disassociated from the event(s) as there is no objective evidence indicating a liberty select cycler deficiency or malfunction caused these event(s) and/or hospitalization.The pdrn reported the patient is frequently non-complaint with many aspects of care, which in this case caused the cp and fo.However, the reported unspecified device alarms could have contributed to the patient not utilizing the cycler, which resulted in cp and fo.Fluid overload is a common and often preventable process.Patient related factors, such as non-compliance, are significant contributing factors (1,2).Should additional information become available the clinical investigation will be updated accordingly.

Event Description

This is a report of a peritoneal dialysis (pd) patient who was hospitalized on (b)(6) 2019 due to reported symptoms of fluid overload and chest pain.The patient was hospitalized through (b)(6) 2019.Prior to hospitalization, the patient left a voicemail fresenius pd software support on (b)(6) 2019 and reported that they were receiving multiple unknown alarms during every cycle.Upon follow up on (b)(6) 2019 the patient reported the hospitalization and that the unknown alarms were occurring since the previous week and he was unable to correct the issue.The patient reverted to continous ambulatory peritoneal dialysis (capd) treatment on an unknown date, he indicated it was not working for him and caused him to swell up and visit the hospital.The patient was advised to discontinue the use of the cycler and follow up with the peritoneal dialysis nurse (pdrn).A new cycler was issued to the patient.Upon follow up with the pdrn, it was reported that the patient had not completed capd as was advised by the clinic and the patient did not perform continous cycling peritoneal dialysis (ccpd) for three consecutive days.During the hospitalization, the patient received a temporary hemodialysis (hd) catheter (non fresenius product) and underwent two hd sessions successfully.Per the pdrn, the patient has a history of non-compliance with multiple aspects of his care.The pdrn stated the events were not related to the liberty select cycler, but rather the patient¿s non-compliance (skipping 3 days of therapy).Additional information has been requested from the clinic but to this date has not been received.The reported cycler has been returned to the manufacturer for physical 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; director, quality systems; 4040 nelson avenue; concord CA 94520
• Manufacturer Contact: amaral, matthew ; 920 winter st.; waltham, MA 02451 ; 7816999758
• MDR Report Key: 8768549
• MDR Text Key: 150408228
• Report Number: 2937457-2019-02078
• 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: K181108
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 07/08/2019

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 Catalogue Number: RTLR180343
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/25/2019
• Device Age: MO
• Initial Date Manufacturer Received: 06/10/2019
• Initial Date FDA Received: 07/08/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/31/2010
• 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): Hospitalization; Required Intervention