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

Model Number 180343

Device Problems Smoking (1585); Noise, Audible (3273)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/09/2022

Event Type  malfunction  

Event Description

It was reported that a peritoneal dialysis (pd) patient discovered smoke and the cassette door popped open after ending their pd treatment.When the cassette door popped open there was a loud pop noise and smoke was coming from inside the cassette door.The patient was not connected when the door popped open.The patient was advised to discontinue the use of their cycler and follow up with their peritoneal dialysis nurse (pdrn).A new cycler was issued to the patient.It was reported that an alternate treatment option was available.Upon follow up, the patient contact stated the patient is trained on performing stat drains, as well as manual peritoneal dialysis therapy if needed.The patient aborted their treatment.The patient did not develop any symptoms, adverse events, injuries, or require medical intervention as a result of the reported event.The patient contact stated that they observed smoke coming out of the cassette door for a second and then didn't see it anymore.The patient contact stated they did not observe any char, melting or signs of burning.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 plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity. .

Event Description

It was reported that a peritoneal dialysis (pd) patient discovered smoke and the cassette door popped open after ending their pd treatment.When the cassette door popped open there was a loud pop noise and smoke was coming from inside the cassette door.The patient was not connected when the door popped open.The patient was advised to discontinue the use of their cycler and follow up with their peritoneal dialysis nurse (pdrn).A new cycler was issued to the patient.It was reported that an alternate treatment option was available.Upon follow up, the patient contact stated the patient is trained on performing stat drains, as well as manual peritoneal dialysis therapy if needed.The patient aborted their treatment.The patient did not develop any symptoms, adverse events, injuries, or require medical intervention as a result of the reported event.The patient contact stated that they observed smoke coming out of the cassette door for a second and then didn¿t see it anymore.The patient contact stated they did not observe any char, melting or signs of burning.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

Additional information: d9, h3 plant investigation: the actual device was returned to the manufacturer for physical evaluation.An external visual inspection was performed on the cycler with no physical damage noted.There were visual indications of dried fluid within the cassette compartment on the pump door and on the pump molded clamp.There were no visual indications of particulates within the cassette area.There were no burrs or sharp edges in cassette area that may have punctured a cassette membrane.The cycler underwent and passed a system air leak test, balloon valve actuation test, and door/cassette switch.Post-accelerated stress test 2-hours 15-minutes 8500ml simulated treatment was performed and passed with no further alarms or issues.No fluid leaks in the test cassette during the treatment test.An investigation of the cycler mushroom heads verified that the surface conditions and alignments were within specification.An internal visual inspection of the returned cycler was performed and found no discrepancies.No evidence of smoke was found during troubleshooting.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.

Event Description

It was reported that a peritoneal dialysis (pd) patient discovered smoke and the cassette door popped open after ending their pd treatment.When the cassette door popped open there was a loud pop noise and smoke was coming from inside the cassette door.The patient was not connected when the door popped open.The patient was advised to discontinue the use of their cycler and follow up with their peritoneal dialysis nurse (pdrn).A new cycler was issued to the patient.It was reported that an alternate treatment option was available.Upon follow up, the patient contact stated the patient is trained on performing stat drains, as well as manual peritoneal dialysis therapy if needed.The patient aborted their treatment.The patient did not develop any symptoms, adverse events, injuries, or require medical intervention as a result of the reported event.The patient contact stated that they observed smoke coming out of the cassette door for a second and then didn¿t see it anymore.The patient contact stated they did not observe any char, melting or signs of burning.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.

• Brand Name: LIBERTY SELECT CYCLER ASSY(NON-VALUATED)
• Type of Device: SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
• Manufacturer (Section D): CONCORD MANUFACTURING; director, quality systems; 4040 nelson avenue; concord CA 94520
• Manufacturer (Section G): CONCORD MANUFACTURING; director, quality systems; 4040 nelson avenue; concord CA 94520
• Manufacturer Contact: jason busch ; 920 winter st; waltham, MA 02451 ; 9043166958
• MDR Report Key: 13595392
• MDR Text Key: 286108036
• Report Number: 2937457-2022-00309
• 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,Followup
• Report Date: 03/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 180343
• Device Catalogue Number: RTLR180343
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/22/2022
• Device Age: MO
• Date Manufacturer Received: 03/14/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/09/2009
• 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
• Treatment: DELFLEX PD FLUID; DELFLEX PD FLUID; DELFLEX PD FLUID; LIBERTY CYCLER SET ; LIBERTY CYCLER SET ; LIBERTY CYCLER SET
• Patient Age: 76 YR
• Patient Sex: Male
• Patient Weight: 73 KG