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

Model Number 180343

Device Problems Intermittent Shock/Stimulation (2287); Unintended Electrical Shock (4018)

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

Event Date 08/04/2020

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 contacted fresenius technical support to report physical damaged to the liberty cycler.Patient also stated that the cycler causes them to get "shocked" when they are connected and they touch the light plates.The fresenius technical support representative issued a replacement cycler and advised the patient to discontinue using the machine.Upon follow-up with the patient's peritoneal dialysis registered nurse (pdrn), it was reported that the patient was able to complete treatment using manuals.The pdrn could not confirm the patient's report of being "shocked".Upon follow-up, the patient stated that they believed that the cycler was giving them an electrical current when dialyzing.The patient confirmed that they did not develop and symptoms, injury, adverse event, or require medical intervention as a result of the reported complaint.The patient stated that there was no pain, but described it as a "sensation".The old cycler was returned to the manufacture for evaluation.The new cycler was received and the patient continues pd therapy without issue.

Manufacturer Narrative

Correction: h6 device code.

Manufacturer Narrative

Plant investigation: the actual device was returned to the manufacturer for physical evaluation.A visual inspection of the returned cycler exterior showed paint cracking on heater tray and cracked front panel bezel.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 cassette area that may have punctured a cassette membrane.The patient sensors passed.Post-accelerated stress test (ast) 2-hour 15-minute 8500ml simulated treatment was performed without any failures or problems.The mushroom head check passed.An internal visual inspection of the returned cycler encountered no discrepancies.All electrical safety checks passed (voltage check and hipot test).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: 10446208
• MDR Text Key: 204360485
• Report Number: 2937457-2020-01520
• 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: company representative,consum
• Type of Report: Initial,Followup,Followup
• Report Date: 09/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/24/2020
• 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: 08/19/2020
• Device Age: MO
• Date Manufacturer Received: 09/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: DELFLEX PD FLUID; LIBERTY CYCLER SET
• Patient Age: 67 YR
• Patient Weight: 92