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

Catalog Number RTLR180343

Device Problems Melted (1385); Sparking (2595)

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

Event Date 03/18/2019

Event Type  malfunction  

Manufacturer Narrative

The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.

Event Description

A peritoneal dialysis patient contacted fresenius technical support reported that the liberty select (b)(6) modem new -kit (serial number: (b)(4)) modem power cord that connected to the wall outlet was melted.The patient was advised to discontinue the use of the modem power cord.Upon follow, the patient confirmed the melted power on the modem not the cycler.The patient stated that there was melting, and spark observed from the outlet.The patient stated that a burn plastic smell was observed.There was no fire or smoke observed.There were no leaks and the modem was dry.The pdrn stated that there weren¿t any pictures available.The modem was returned to the manufacturer for physical evaluation.The pdrn stated that a new modem was sent to the patient.The patient was able to complete treatment on the cycler and is continuing pd therapy.The patient did not develop any symptoms, adverse events, injuries, or require medical intervention as a result of the reported event.

Manufacturer Narrative

Additional information: the modem or power cord were not returned to the manufacturer for physical evaluation.There wasn¿t enough information provided for an investigation.

• 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: matthew amaral ; 920 winter st.; waltham, MA 02451 ; 7816999758
• MDR Report Key: 8449434
• MDR Text Key: 139752499
• Report Number: 1225714-2019-00003
• 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
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 04/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: RTLR180343
• Was Device Available for Evaluation?: No
• Device Age: MO
• Initial Date Manufacturer Received: 03/18/2019
• Initial Date FDA Received: 03/25/2019
• Supplement Dates Manufacturer Received: 04/18/2019
• Supplement Dates FDA Received: 04/19/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/20/2018
• 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: DELFLEX PD FLUID; LIBERTY CYCLER SET
• Patient Age: 58 YR
• Patient Weight: 120