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

Catalog Number 190713

Device Problem Thermal Decomposition of Device (1071)

Patient Problem No Patient Involvement (2645)

Event Date 10/03/2017

Event Type  malfunction  

Manufacturer Narrative

Plant investigation: the actual device was returned to the manufacturer for physical evaluation and the complaint was confirmed.The returned ui-mics board was installed on a test machine.Upon power up, the machine had a blank display.A visual inspection of the returned ui-mics board was performed and identified a burnt r50 resistor.Upon replacing the resistor and re-installing the ui-mics board, the testing machine powered up in dialysis mode without failure.The display was then toggled in an attempt to change to cdx mode from the dialysis mode.The machine produced a "cdx not installed" message which was resolved by reprogramming the software on the ui-mics board.Upon conclusion of the investigation, the board was repaired and returned to service.The cause of the blank display screen was a result of a burnt r50 resistor.The cause of the burnt resistor was unknown.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported by a biomedical technician that the cdx screen of a 2008t hemodialysis machine was not legible upon power up.Upon inspection by a regional equipment specialist, the ui-mics board was replaced and the issue was resolved.The ui-mics board was returned and during physical evaluation it was discovered that the r50 resistor had burnt out.The resistor was replaced and the ui-mics board was re-installed in another machine for testing.The machine properly powered up and the software of the ui-mics board was reprogrammed.The cdx mode functioned properly following the resistor replacement and the software reprogramming.The cause for the burnt resistor was unknown.There was no patient involved with this event.

Manufacturer Narrative

Plant investigation: an investigation of the device manufacturing records was conducted and verified that there were no non-conformances or abnormalities identified during the manufacturing process which could be associated with the reported event.In addition, a device history records (dhr) review was performed and confirmed that the results of the in-progress and final quality control (qc) testing met all requirements.A definitive conclusion regarding the reported incident could not be reached and a cause for the burnt resistor remains unknown.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: 7041625
• MDR Text Key: 93210414
• Report Number: 2937457-2017-01197
• 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,other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/24/2018

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: Other
• Device Catalogue Number: 190713
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/11/2017
• Is the Reporter a Health Professional?: No
• Device Age: MO
• Initial Date Manufacturer Received: 10/27/2017
• Initial Date FDA Received: 11/17/2017
• Supplement Dates Manufacturer Received: 01/23/2018
• Supplement Dates FDA Received: 01/24/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/10/2016
• 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