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

Model Number LIBERTY CYCLER

Device Problem Power Problem (3010)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/16/2017

Event Type  Injury  

Manufacturer Narrative

The device has not been returned to the manufacturer.A supplemental report will be filed upon completion of the manufacturer's investigation.

Event Description

A peritoneal dialysis patient reported that the cycler powered down during treatment on the previous day.The patient stated that in the middle of treatment, the cycler stopped working and subsequently would no longer turn on.The patient was in the hospital while reporting this event.The cycler will be replaced.

Manufacturer Narrative

Clinical investigation: the file has been assessed for the necessity of the performance of a clinical investigation.A review of the file information was conducted and revealed the patient was hospitalized during a call to customer service on (b)(6) 2017 regarding a potential liberty cycler event.A request for additional information was completed, however there has been no response as of (b)(6) 2017.There is no documentation or indication that any fresenius device(s) caused or contributed to a serious adverse patient outcome.Therefore, the completion of a clinical investigation is not warranted at this time.Should additional information become available regarding a serious adverse event experienced by a patient and/or user related to a fresenius device(s) and/or product(s), please re-submit for a clinical investigation review and the need for a clinical investigation will be re-evaluated accordingly.

Event Description

A peritoneal dialysis patient reported that the cycler powered down during treatment on the previous day.The patient stated that in the middle of treatment, the cycler stopped working and subsequently would no longer turn on.The patient was in the hospital while reporting this event.The cycler will be replaced.

Manufacturer Narrative

Device evaluation: the device was not returned to the manufacturer for physical evaluation and the failure mode cannot be confirmed.However, an investigation of the device manufacturing records was conducted by the manufacturer.There were no deviations or non-conformances during the manufacturing process.All device history records (dhr) are reviewed and released according to the dhr review checklist and release procedure.A device is not released if it does not meet requirements or is nonconforming.In addition, the device record review confirmed the labeling, material, and process controls were within specification.

Event Description

A peritoneal dialysis patient reported that the cycler powered down during treatment on the previous day.The patient stated that in the middle of treatment, the cycler stopped working and subsequently would no longer turn on.The patient was in the hospital while reporting this event.The cycler will be replaced.

• Brand Name: LIBERTY 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: 7109023
• MDR Text Key: 94538830
• Report Number: 2937457-2017-01325
• Device Sequence Number: 1
• Product Code: FKX
• UDI-Device Identifier: 00840861100972
• UDI-Public: 00840861100972
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K123630
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Patient
• Type of Report: Initial,Followup,Followup
• Report Date: 04/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/12/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: LIBERTY CYCLER
• Device Catalogue Number: RTLR180111
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Device Age: MO
• Event Location: Home
• Date Manufacturer Received: 04/11/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/12/2010
• 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
• Treatment: LIBERTY CYCLER SET; PD FLUID
• Patient Outcome(s): Hospitalization