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

Model Number 180343

Device Problem Unintended Electrical Shock (4018)

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

Event Date 02/28/2023

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 experienced an electrical shock when they touched the heater tray during their pd treatment.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 stated they are 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 stated that they did not observe any burning smell, smoke, flame, or arching.The patient stated that they only experienced an electrical shock coming from the heater tray of the cycler.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

Correction: g3 was incorrect, the correct date is 4/17/2023.

Event Description

It was reported that a peritoneal dialysis (pd) patient experienced an electrical shock when they touched the heater tray during their pd treatment.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 stated they are 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 stated that they did not observe any burning smell, smoke, flame, or arching.The patient stated that they only experienced an electrical shock coming from the heater tray of the cycler.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.There were visual indications of dried fluid within the cassette compartment.There were no visual indications of particulates within the cassette area.There were no burrs or sharp edges in the cassette area that may have punctured a cassette membrane.Voltage, patient hi pot, hit pot, and safety analyzer had passed.The post accelerated stress test 2 hours 15 minutes 8500ml simulated treatment was performed without any failures or problems.The mushroom head check passed.An internal visual inspection of the returned cycler was performed.There were visual indications of dried fluid under the pump assembly on the bottom cover.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 experienced an electrical shock when they touched the heater tray during their pd treatment.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 stated they are 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 stated that they did not observe any burning smell, smoke, flame, or arching.The patient stated that they only experienced an electrical shock coming from the heater tray of the cycler.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: jessica trujillo ; 920 winter st; waltham, MA 02451 ; 6174175172
• MDR Report Key: 16598451
• MDR Text Key: 312035308
• Report Number: 0002937457-2023-00433
• 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: 05/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2023
• 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
• Device Age: MO
• Date Manufacturer Received: 05/08/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/05/2016
• 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: 78 YR
• Patient Sex: Male
• Patient Weight: 93 KG