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

Catalog Number RTLR180343

Device Problem Smoking (1585)

Patient Problem No Patient Involvement (2645)

Event Date 06/13/2019

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported a peritoneal dialysis (pd) patient turned on the cycler and the screen started to flicker.Subsequently, a sound like air releasing or a pop-like-sound came from the cycler and then the patient noticed white smoke coming from the back of the cycler.The cycler then turned off.The patient attempted to turn on cycler and switch the outlets, but the lights did not come on.At that point in time, the technical support representative advised the patient to discontinue use of the cycler and issues a replacement cycler to the patient.It was reported that an alternate treatment was available.The patient was advised to notify their peritoneal dialysis registered nurse (pdrn) of the event.Upon follow-up the pdrn stated that the patient is trained on performing stat drains, as well as manual peritoneal dialysis therapy if needed, and confirmed that the patient was able to complete peritoneal dialysis treatment using continuous ambulatory peritoneal dialysis (capd) in the absence of the cycler.The patient did not develop any symptoms, adverse events, injuries, or require medical intervention as a result of the reported event.The patient has received a new cycler which is working well and is continuing peritoneal dialysis therapy with no further issues.The cycler was returned to the manufacturer for physical evaluation.

Manufacturer Narrative

The actual device was returned to the manufacturer for evaluation.An exterior visual inspection of the returned cycler encountered insect infestation.The voltage check test failed.Failure due to cycler not powering on caused by a defective power supply.The customer report of "smoke" could not be confirmed during evaluation.An internal, visual inspection of the received cycler unit encountered insect infestation.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.

• 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: 8734842
• MDR Text Key: 149202491
• Report Number: 2937457-2019-01995
• 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,Followup
• Report Date: 07/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 07/02/2019
• Device Age: MO
• Initial Date Manufacturer Received: 06/13/2019
• Initial Date FDA Received: 06/26/2019
• Supplement Dates Manufacturer Received: 07/02/2019
• Supplement Dates FDA Received: 07/15/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2019
• 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