MAUDE Adverse Event Report: CONCORD MANUFACTURING LIBERTY SELECT CYCLER; SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

Catalog Number RTLR180343

Device Problem Device Issue (2379)

Patient Problem No Information (3190)

Event Date 01/29/2018

Event Type  Injury  

Manufacturer Narrative

A supplemental mdr will be submitted upon device evaluation.

Event Description

During follow up on an unrelated incident a peritoneal dialysis patient's nurse reported the patient had been hospitalized.During follow up the nurse reported the patient had "some issues with the cycler." the reason for hospitalization was unknown.The patient was discharged to a skilled nursing facility and had transitioned to hemodialysis.Further information has been solicited but not made available.

Manufacturer Narrative

Date on initial should have been (b)(6) 2018.

Manufacturer Narrative

There does not appear to be a temporal relationship between the liberty select cycler and the patient¿s hospitalization for unknown reason.The patient reportedly was completing pd therapy via manual exchanges prior to hospitalization due to the patient¿s previous cycler being processed for replacement after experiencing alarms during set-up of ccpd treatment.Based on the lack of sufficient information, it cannot be determined if the liberty select cycler may have caused on contributed to the patient¿s hospitalization the actual device was not returned to the manufacturer for physical evaluation.However, an investigation of the device manufacturing records was conducted by the manufacturer.There were no deviations or non-conformances during the manufacturing process.In addition, the device manufacturing review confirmed the labeling, material, and process controls were within specification.

• Brand Name: LIBERTY SELECT CYCLER
• 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: 7311618
• MDR Text Key: 101462449
• Report Number: 2937457-2018-00668
• 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: health professional,user faci
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 04/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/02/2018
• 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?: No
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Date Manufacturer Received: 04/13/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2009
• 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