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

Catalog Number RTLR180343

Device Problems Melted (1385); Smoking (1585)

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

Event Date 01/16/2019

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 registered nurse (pdrn) contacted fresenius technical support to report the liberty modem (b)(6) 2g ( serial number: (b)(4)) tripped the circuit breaker and upon power up of the modem, there was visible smoke.Upon follow up, the pdrn confirmed the smoke coming from the modem not the cycler.The pdrn stated that there was melting, and electrical heat damaged observed.There were no reports of leaks from the modem.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.The pdrn did not observe any obvious wiring issues.The modem was plugged into the same outlet as the cycler.

Manufacturer Narrative

Plant investigation: the actual device was returned to the manufacturer for physical evaluation.The modem showed no visible damage and did not have a smoke odor.Verified via multi-meter that no electrical short existed between power and ground terminals on power adapter.Some debris (corrosion) was noted near the antenna connector.This did not impact unit¿s ability to make a cellular connection once antenna was attached.Power adapter was connected, and modem lit ¿pwr¿ led to green and ¿ls¿ led blinked green.The serial cable was attached (no change in status).The antenna was connected and after a brief delay, modem lit 2 signal strength leds to green.The modem was allowed to sit on a lab bench for approximately 6 hours and periodically monitored for abnormal smell or temperature.After 6 hours of elapsed time, no abnormal smell was detected at normal operational temperature.The modem performed as intended and no smoke was detected.An operational validation was not performed, rather the unit was powered on and monitored.

• 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: matthew amaral ; 920 winter st.; waltham, MA 02451 ; 7816999758
• MDR Report Key: 8302700
• MDR Text Key: 134924955
• Report Number: 1225714-2019-00001
• 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: health professional,user faci
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 03/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/04/2019
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: RTLR180343
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/13/2019
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Date Manufacturer Received: 02/14/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/22/2018
• 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: 78 YR
• Patient Weight: 107