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 07/01/2021

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

A peritoneal dialysis (pd) patient reported the patient contact witnessed a small spark on the back of the liberty select cycler around the power cord socket.The patient stated that this issue occurred after the patient contact moved the cycler from one room to another room during an unknown step of setup of their treatment.The patient reported that the cycler has been working fine since that day.The patient was advised to discontinue the use of their cycler and follow up with their peritoneal dialysis registered 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 stated they are trained on performing stat drains, as well as manual peritoneal dialysis therapy if needed.The patient stated that they completed their treatment.The patient stated that there was no patient involvement as the issue occurred during setup.The patient stated that the patient contact witnessed a spark coming from the plug of the cycler.The patient stated they did not observe any burning smell, smoke, flame, or arcing.The patient did not develop any symptoms, adverse events, injuries, or require medical intervention as a result of the reported event.The patient confirmed that a replacement cycler has been received, but they sent it back to the manufacturer.The patient stated that they are continuing to use their old cycler without issue and without reoccurrence of the reported event.

Manufacturer Narrative

Plant investigation: no parts were returned to the manufacturer for physical evaluation.A records review was performed on the reported serial number.An investigation of the device manufacturing records was conducted by the manufacturer.There were no non-conformances, or any associated rework identified during the manufacturing process which could be related to the reported event.In addition, the device history record (dhr) review confirmed the results of the in-progress and final quality control (qc) testing met all requirements.The investigation into the cause of the reported problem was not able to be confirmed.A definitive conclusion regarding the complaint incident cannot be reached without a physical examination of the complaint device.

Event Description

A peritoneal dialysis (pd) patient reported the patient contact witnessed a small spark on the back of the liberty select cycler around the power cord socket.The patient stated that this issue occurred after the patient contact moved the cycler from one room to another room during an unknown step of setup of their treatment.The patient reported that the cycler has been working fine since that day.The patient was advised to discontinue the use of their cycler and follow up with their peritoneal dialysis registered 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 stated they are trained on performing stat drains, as well as manual peritoneal dialysis therapy if needed.The patient stated that they completed their treatment.The patient stated that there was no patient involvement as the issue occurred during setup.The patient stated that the patient contact witnessed a spark coming from the plug of the cycler.The patient stated they did not observe any burning smell, smoke, flame, or arcing.The patient did not develop any symptoms, adverse events, injuries, or require medical intervention as a result of the reported event.The patient confirmed that a replacement cycler has been received, but they sent it back to the manufacturer.The patient stated that they are continuing to use their old cycler without issue and without reoccurrence of the reported event.

• 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: 12363306
• MDR Text Key: 268045393
• Report Number: 2937457-2021-01774
• 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
• Report Date: 11/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/24/2021
• 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?: No
• Device Age: MO
• Date Manufacturer Received: 10/27/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/29/2013
• 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 Age: 68 YR
• Patient Sex: Female
• Patient Weight: 104 KG