MAUDE Adverse Event Report: CONCORD MANUFACTURING 2008T HEMODIALYSIS SYSTEM W/BIBAG; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Catalog Number 190766

Device Problems Thermal Decomposition of Device (1071); Melted (1385)

Patient Problem No Patient Involvement (2645)

Event Date 12/20/2019

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 fresenius field service technician (fst) was called on site by a user facility to repair a 2008t machine that had a burnt power plug.The fst confirmed there to be visual evidence of burn damage on the plug.Upon follow up, the fst reported that an area around the prongs looked blackened and slightly melted.The fst reported there was an inadequacy with the outlet that the machine was plugged into.The fst stated the customer called an electrician on site to inspect the outlet, and the outlet was reportedly replaced.The fst could not confirm if the customer keeps the machine plugged into a hospital grade ground-fault circuit interrupter (gfci) outlet.It was also unknown if the machine had a previous history of failing the electrical leakage test.The fst replaced the burnt component with a hospital grade 15 amp power plug to resolve the reported issue.To the fst¿s knowledge, there have been no further issues with the machine.The burnt plug was not available to be sent back for evaluation as it was reportedly discarded.There was no patient involvement associated with the reported incident.Multiple attempts were made to contact the customer for additional information; no additional details could be obtained.

Manufacturer Narrative

Plant investigation: no parts were returned to the manufacturer for physical evaluation.However, an on-site evaluation was performed by a fresenius field service technician (fst).To resolve the reported issue, the fst replaced the burnt component with a hospital grade 15 amp power plug.In addition, an electrician was called on-site to inspect the power outlet that the machine was plugged into.This reported visit resulted in the replacement of the power outlet.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 able to confirm the reported failure mode.The fresenius fst confirmed there was heat damage on the power plug based on visual evidence of a burn mark near one of the plug's prongs, as well as evidence of melting.Therefore, the complaint event was confirmed.

• Brand Name: 2008T HEMODIALYSIS SYSTEM W/BIBAG
• Type of Device: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): CONCORD MANUFACTURING; director, quality systems; 4040 nelson avenue; concord CA 94520
• MDR Report Key: 9542028
• MDR Text Key: 173442342
• Report Number: 2937457-2020-00014
• Device Sequence Number: 1
• Product Code: KDI
• UDI-Device Identifier: 00840861100910
• UDI-Public: 00840861100910
• Combination Product (y/n): N
• PMA/PMN Number: K121341
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 01/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/02/2020
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 190766
• Was Device Available for Evaluation?: Yes
• Device Age: MO
• Date Manufacturer Received: 01/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1