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 Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/15/2021

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 spark was coming from a peritoneal dialysis (pd) patient¿s cycler.The patient contact reported the cycler fell from a cycler cart and the back side of the cycler was damaged.When the cycler was turned on sparks were noted from the cycler.No smoke or burning smell was noted.The patient was not connected during the incident.At that point in time, the technical support representative advised the patient to discontinue use of the cycler.It was reported that an alternate treatment was available.A replacement cycler was issued to the patient.Upon follow up, the pdrn confirmed the patient was not connected to the cycler and powered up the cycler when the reported event occurred.The pdrn confirmed that there was no harm because of this malfunction.The patient did not develop any symptoms, adverse events, injuries, or require medical intervention as a result of the reported event.The pdrn indicated the spark only occurred once on the day the patient contact called into technical support.The pdrn stated that no burning smell melting or flame was noted.The pdrn stated that the patient was able to complete the peritoneal dialysis treatment using continuous ambulatory peritoneal dialysis (capd) in the absence of the cycler.The pdrn confirmed the patient received a replacement cycler and has had no further issues.The cycler has been returned to the manufacturer for physical evaluation.

Manufacturer Narrative

Plant investigation: the actual device was returned to the manufacturer for physical evaluation.A visual inspection of the returned cycler exterior showed signs of physical damage.The power entry module is damaged.There were visual indications of dried fluid within the cassette compartment.There were 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.The power entry module was replaced with a known good power entry module and continued testing.The known good power entry module was removed at the completion of the investigation.A pre-accelerated stress test (ast) was performed on the cycler and passed.There were no fluid leaks in the test cassette during the pre-accelerated stress test.The cycler underwent and passed a hipot test, system air leak test, and patient hipot test and voltage check.There were visual indications of dried fluid under pump ¿a¿ and ¿b¿ mushroom head and within the recess of the bottom cover adjacent to the pump assembly.The cause of the observed dried fluid and fluid could not be determined.Mushroom head checks passed.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, the reported issue was confirmed.The cycler was refurbished following the evaluation.

Event Description

It was reported that a spark was coming from a peritoneal dialysis (pd) patient¿s cycler.The patient contact reported the cycler fell from a cycler cart and the back side of the cycler was damaged.When the cycler was turned on sparks were noted from the cycler.No smoke or burning smell was noted.The patient was not connected during the incident.At that point in time, the technical support representative advised the patient to discontinue use of the cycler.It was reported that an alternate treatment was available.A replacement cycler was issued to the patient.Upon follow up, the pdrn confirmed the patient was not connected to the cycler and powered up the cycler when the reported event occurred.The pdrn confirmed that there was no harm because of this malfunction.The patient did not develop any symptoms, adverse events, injuries, or require medical intervention as a result of the reported event.The pdrn indicated the spark only occurred once on the day the patient contact called into technical support.The pdrn stated that no burning smell melting or flame was noted.The pdrn stated that the patient was able to complete the peritoneal dialysis treatment using continuous ambulatory peritoneal dialysis (capd) in the absence of the cycler.The pdrn confirmed the patient received a replacement cycler and has had had no further issues.The cycler has been 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: matthew amaral ; 920 winter st; waltham, MA 02451 ; 7816999758
• MDR Report Key: 12665537
• MDR Text Key: 277417893
• Report Number: 2937457-2021-02098
• 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,User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 11/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 11/03/2021
• Device Age: MO
• Initial Date Manufacturer Received: 10/15/2021
• Initial Date FDA Received: 10/20/2021
• Supplement Dates Manufacturer Received: 11/30/2021
• Supplement Dates FDA Received: 11/30/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/30/2014
• 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