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

Model Number 2008T

Device Problems Smoking (1585); Sparking (2595)

Patient Problem No Patient Involvement (2645)

Event Date 02/28/2017

Event Type  malfunction  

Manufacturer Narrative

The device was not returned to the manufacturer for physical evaluation, however, an on-site evaluation of the unit was performed by a fresenius regional equipment specialist (res).The res replaced the power control board to resolve the 24 volt low error.Functional testing performed by the res confirmed that the system was operating properly.The 2008t hemodialysis (hd) machine was 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.The investigation into the cause of the reported problem was able to confirm the failure mode.Therefore, the complaint has been deemed confirmed.

Event Description

A biomedical technician from the user facility requested on-site service from a fresenius regional equipment specialist (res).Follow-up provided by the biomed revealed that the black cable from the power supply to the distribution board made contact with a screw that is located next to the blood pressure tubing.When the cable contacted the screw, the biomed reportedly saw a spark, followed by a puff of smoke.After the spark was observed, the 2008t hemodialysis (hd) machine generated a 24 volt low error.There was no patient connected to the system at the time of the incident.A res performed an on-site evaluation of the machine.The res replaced the power control board to resolve the 24 volt low error.Functional testing performed by the res confirmed the system was operating properly.The unit has been returned to service at the user facility without a recurrence of the event as reported.

• 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: 6435885
• MDR Text Key: 70910361
• Report Number: 2937457-2017-00204
• 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
• Report Date: 03/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2017
• 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: 02/28/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/18/2016
• 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