MAUDE Adverse Event Report: CONCORD MANUFACTURING 2008T HEMODIALYSIS SYS., WITH CDX; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Catalog Number 190713

Device Problems Thermal Decomposition of Device (1071); Charred (1086); Melted (1385)

Patient Problem No Patient Involvement (2645)

Event Date 01/08/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

A biomedical engineer (biomed) at a user facility reported that the fresenius 2008t hemodialysis (hd) machine had a burned, charred, and melted power plug.This was observed during inspection of the plug end.A patient was not connected to the machine at the time of the incident and there was no harm to any patients or individuals because of this event.The plug was the original fresenius part on the machine.The biomed reported that there was no burning smell, smoke, spark or flame observed.There was no damage observed on any other components.All electrical leakage tests for the machine had passed.The machine is plugged into a hospital grade ground-fault circuit interrupter (gfci) outlet.The biomed replaced the power cord and plug assembly, which resolved the issue.The unit was returned to service at the user facility without a recurrence of the event as reported.The power cord and plug assembly was stated to be available to be returned to the manufacturer for physical evaluation.

Manufacturer Narrative

Device evaluation: the power supply cord and plug assembly was returned to the manufacturer for analysis.A visual examination was performed which revealed signs of discoloration and melting from heat damage in the clear molding of the neutral side of the plug and arcing and pitting on the neutral prong of the plug.There was no discrepancy observed on the cord part.A functional resistance test was performed on the plug by measuring the resistance between 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 had continuity; the hot and neutral wires were at 0.2 ohms and the ground wire was at 0.3 ohms from end to end and the resistance between each wire was open, as expected.Functional testing was performed by installing the received part into a working test unit.The plug was found to fit securely into an outlet which could not easily be unplugged.The test unit powered on without any failures.There were no sparks observed.The test unit was able to complete the self-test program and rinse program without any failures and without causing any further damages to the plug.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 related to the reported event.In addition, the device history record review confirmed the results of the in-progress and final quality control testing met all requirements and did not reveal any issues or problems related to the reported complaint.The investigation into the cause of the complaint was able to confirm the reported event.A visual examination of the power plug confirmed that the part sustained heat damage.Therefore, the complaint has been deemed confirmed.

• Brand Name: 2008T HEMODIALYSIS SYS., WITH CDX
• 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: 7215313
• MDR Text Key: 98291237
• Report Number: 2937457-2018-00248
• Device Sequence Number: 1
• Product Code: KDI
• UDI-Device Identifier: 00840861100897
• UDI-Public: 00840861100897
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K093902
• 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,Followup
• Report Date: 02/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/24/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 190713
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/19/2018
• Is the Reporter a Health Professional?: No
• Device Age: MO
• Date Manufacturer Received: 02/05/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/19/2014
• 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