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); Pitted (1460); Smoking (1585)

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

Event Date 12/08/2017

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that the plug of a fresenius 2008t hemodialysis (hd) machine had blackened and begun to smoke.Follow-up with the clinic manager and biomedical technician revealed that the event occurred while a patient was performing their hemodialysis treatment on the machine.The patient was transferred to a new machine and was able to complete their treatment without complications.There was no blood loss or harm to the patient resulting from the malfunction.There was no reported damage to any other parts on the machine.The burnt plug was original to the machine and the machine had approximately 9,164 hours.The machine was plugged into a hospital grade ground-fault circuit interrupter (gfci) outlet.The biomedical technician replaced the burnt component and the machine was returned to service at the user facility.The burnt plug was reported to be available for evaluation.Additional information was requested but was not available.

Manufacturer Narrative

Additional information provided for: the facility's email address is (b)(6).Plant investigation: the power supply cable was returned to the manufacturer for physical evaluation.An initial visual inspection was performed and confirmed the reported burn damage on the component.The plastic around the terminal of the white wire in the power plug was melted.The terminal itself had pitting and discolored metal.During electrical testing, the power supply cable was found to have good continuity.Upon installing the returned power supply cable on a test machine, the machine powered on and completed a self-test program without alarms or failure.An investigation 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 conclusion of the investigation, the reported issue was confirmed.It was noted that pitting on the power plug terminal indicates possible arcing within the outlet used at the facility.Furthermore, the discolored metal indicates potential corrosion.Hospital grade outlets are required with the use of the 2008t machine.The plug was replaced by the clinic biomedical technician and the machine was put back into service.Should additional relevant information become available, a supplemental report will be submitted.

• 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: 7156521
• MDR Text Key: 96121412
• Report Number: 2937457-2018-00003
• 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,health
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 01/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 12/27/2017
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Initial Date Manufacturer Received: 12/11/2017
• Initial Date FDA Received: 01/02/2018
• Supplement Dates Manufacturer Received: 01/02/2018
• Supplement Dates FDA Received: 01/10/2018
• Was Device Evaluated by Manufacturer?: Yes
• 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