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

Catalog Number RTLR180343

Device Problems Sparking (2595); Noise, Audible (3273)

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

Event Date 12/28/2023

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 that a peritoneal dialysis (pd) patient heard a noise that sounded like fireworks popping, saw sparks/flash from the side of the cycler, the door popped open and the cassette popped open during their pd treatment.The patient reported receiving a pressure leak alarm during dwell 1 of treatment and the treatment was cancelled.The cause of the event is unknown.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 not available.Upon follow up, the pdrn stated the patient is not trained on performing stat drains, as well as manual peritoneal dialysis therapy if needed.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 set used by the patient was discarded and is not available for return for physical evaluation by the manufacturer.The cycler was returned to the manufacturer for physical evaluation.

Manufacturer Narrative

Additional information provided in d9 and 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.There was no visual indication of particulates within the cassette area.There were no burrs or sharp edges in cassette area that may have punctured a cassette membrane a (as received with reduced dwell) simulated treatment was performed and completed.The sound (noise) emitted from the cycler during the test treatment was normal.Pump door test failed.Failure traced due to catch post damaged.The cycler underwent and passed a system air leak test, valve actuation test, teach pump test, safety clamp operation check, hipot test, and patient sensor calibration check.An investigation of the cycler mushroom heads verified that the surface conditions and alignments were within specification.There were visual indications of dried fluid on the bottom cover underneath the pump assembly and infestation.The cause of the observed dried fluid could not be determined.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 heard a noise that sounded like fireworks popping, saw sparks/flash from the side of the cycler, the door popped open and the cassette popped open during their pd treatment.The patient reported receiving a pressure leak alarm during dwell 1 of treatment and the treatment was cancelled.The cause of the event is unknown.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 not available.Upon follow up, the pdrn stated the patient is not trained on performing stat drains, as well as manual peritoneal dialysis therapy if needed.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 set used by the patient was discarded and is not available for return for physical evaluation by the manufacturer.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: jessica trujillo ; 920 winter st; waltham, MA 02451 ; 6174175172
• MDR Report Key: 18467269
• MDR Text Key: 332773467
• Report Number: 0002937457-2024-00033
• Device Sequence Number: 1
• Product Code: FKX
• 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,User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 02/27/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2024
• 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?: Device Returned to Manufacturer
• Device Age: MO
• Date Manufacturer Received: 02/22/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/07/2019
• 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
• Treatment: DELFLEX PD FLUID; DELFLEX PD FLUID; LIBERTY CYCLER SET ; LIBERTY CYCLER SET
• Patient Sex: Male