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

Model Number 180343

Device Problem Sparking (2595)

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

Event Date 01/29/2021

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 contact experienced a spark on the cycler end of the power cord then powered the cycler down.The patient contact was unsure of what phase of treatment the patient was in, but the patient was connected at the time.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 patient contact confirmed the reported event.The patient was unable to complete treatment on the date of the event.The patient contact confirmed that no adverse events were experienced and no medical intervention was required as a result of the reported event.The patient contact clarified that the spark was observed by the patient and was seen within the machine near where the power cord is connected.The event occurred during an unknown phase of cycle 2.The event tripped their home¿s breaker.The patient contact attempted to restart the cycler but it wouldn¿t restart.There was no damage observed on the cycler, cables, nor the surround areas.There was no smoke or burnt smell observed.The replacement cycler was received and the patient was able to continue pd without issues.The previous cycler was returned as scheduled.

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 no visual indications of particulates within the cassette area.Although there was evidence of dried fluid present within the cassette compartment and top cover, there were no burrs or sharp edges in the cassette area that could have punctured the cassette membrane.A post accelerated stress test (ast) 2hours 15mins 8500ml simulated treatment was performed and passed with no further alarms or issues.The cycler underwent and passed a functional/display test, voltage calibration verification, catch-post hipot test, patient hipot test, and safety analyzer test.An investigation of the cycler mushroom heads verified that the surface conditions and alignments were within specification.An internal visual inspection identified evidence of dried fluid on the inside of the rear panel vent.The cause of the 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.

• 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
• MDR Report Key: 11281387
• MDR Text Key: 230627737
• Report Number: 2937457-2021-00193
• Device Sequence Number: 1
• Product Code: FKX
• UDI-Device Identifier: 00840861102068
• UDI-Public: 00840861102068
• Combination Product (y/n): N
• PMA/PMN Number: K181108
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 02/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/04/2021
• 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: 02/22/2021
• Device Age: MO
• Date Manufacturer Received: 02/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: DELFLEX PD FLUID; LIBERTY CYCLER SET
• Patient Age: 14 YR
• Patient Weight: 53