MAUDE Adverse Event Report: CONCORD MANUFACTURING 2008K HEMODIALYSIS SYS. OLC/DIASAFE PLUS; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Model Number 2008K

Device Problem Overheating of Device (1437)

Patient Problem No Patient Involvement (2645)

Event Date 01/17/2018

Event Type  malfunction  

Manufacturer Narrative

Plant investigation: the customer returned two power supply cord and plug assemblies to the manufacturer for analysis.The cord/plug pieces were not identified as belonging to a specific complaint or machine, therefore, both parts were investigated.A visual examination performed and revealed signs of heat damage and discoloration on the power plugs.The plastic molding near the hot and neutral prongs were discolored from heat.There was no observed discoloration near the ground prong.There was no evidence of pitting on the prongs of both plugs.A functional resistance test was performed on the plugs by measuring the resistance between each of the three wires (hot, neutral, and ground).In addition, the continuity was measured from the prongs to the end of the wires.Each wire of the cord found no discrepancies.All three wires on both plugs had continuity at 0.2 ohms from end to end and the resistance was open, as expected.Functional testing was performed by installing the two received cord and plug assemblies into a working unit.The test unit powered on without any failures with both cords.The test unit was able to complete the self-test program without any failures or alarms with both cords.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 during the manufacturing process which could be associated with 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 complaint was able to confirm the reported event.A visual examination of the power supply cord and plug assemblies confirmed that the parts sustained heat damage.Therefore, the complaint has been deemed confirmed.

Event Description

A biomedical engineer (biomed) at a user facility reported that the fresenius 2008k hemodialysis (hd) machine had brown discoloration inside the molded power plug.There was no patient impact regarding this event as the machine was able to be operated without issue.The biomed stated that there was no burned, melted, charred, or blackened damage to the plug or to any other components.The biomed confirmed that there was no observed burning smell, smoke, spark, or flame.The biomed believed that the power plug was the original machine part.The machine is plugged into a hospital-grade outlet, but the biomed could not confirm exactly what type of outlet it was.The biomed ordered a replacement power plug and stated that the part will be replaced when it arrives.The biomed stated that the discolored power plug was available to be returned to the manufacturer for physical evaluation.The manufacturer received two power supply cable and plug assemblies from the customer.There are two events documented for these part returns.The customer did not identify which part belonged to each machine, therefore, the manufacturer evaluated both returned parts under each event.During evaluation, the manufacturer found that the power plugs had heat damage.This submission documents the first heat damage event.The second event is documented under submission #2937457-2018-00938.

• Brand Name: 2008K HEMODIALYSIS SYS. OLC/DIASAFE PLUS
• Type of Device: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): CONCORD MANUFACTURING; 4040 nelson avenue; concord CA 94520
• Manufacturer (Section G): CONCORD MANUFACTURING; 4040 nelson avenue; concord CA 94520
• Manufacturer Contact: thomas c. johnson ; 920 winter st.; waltham, MA 02451 ; 7816999499
• MDR Report Key: 7391427
• MDR Text Key: 104420794
• Report Number: 2937457-2018-00937
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K994267
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/03/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2008K
• Device Catalogue Number: 190371
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/13/2018
• Is the Reporter a Health Professional?: No
• Device Age: MO
• Date Manufacturer Received: 03/16/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/25/2008
• 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