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

Model Number 2008T

Device Problem Charred (1086)

Patient Problem No Patient Involvement (2645)

Event Date 12/15/2016

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The actuator board of a 2008t hemodialysis (hd) machine was found to be "charred" during a routine service repair.Reportedly, the technician who troubleshot the machine was wearing a metal bracelet which came in contact with the actuator board and resulted in minor charring to the board.No smoke was observed, and no flames or sparks were noted.There was no adverse effects experienced by the technician as a result of this event.No patient involvement as the issue occurred while the machine was being serviced.The unit has been returned to service at the user facility without issue.

Manufacturer Narrative

The device was not returned to the manufacturer for physical evaluation.Additionally, no on-site evaluation of the unit was performed by a fresenius regional equipment specialist (res) and no parts were returned for failure analysis.The biomedical technician provided follow-up information which revealed that the actuator board of a 2008t hemodialysis (hd) machine was found to be "charred" during a routine service repair.Reportedly, the technician who troubleshot the machine was wearing a metal bracelet which came in contact with the actuator board and resulted in minor charring to the board.The biomed replaced the actuator board and deaeration pump to resolve the issue.Following the parts replacement, the system was restored to full functionality.The unit has been returned to service at the user facility without issue.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 deviations or non-conformances during the manufacturing process which could be associated with the reported event.In addition, the device history record (dhr) review confirmed the material and process controls were within specification.A definitive conclusion regarding the complaint incident cannot be reached without a physical examination of the complaint device.

• 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: 6241303
• MDR Text Key: 64584699
• Report Number: 2937457-2017-00025
• Device Sequence Number: 1
• Product Code: KDI
• 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: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 02/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Biomedical Engineer
• Device Model Number: 2008T
• Device Catalogue Number: 190713
• Other Device ID Number: 00840861100897
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Date Manufacturer Received: 02/08/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/19/2011
• 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