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

Catalog Number	190858
Medical Device Problem Code	Thermal Decomposition of Device (1071)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/11/2024
Type of Reportable Event	Malfunction
Event or Problem Description
A biomedical technician reported an out of box failure for a function board.The function board was installed and there was a low flow error message with an audible alarm.The technician found the function board eeprom burnt.Another board was ordered.In a follow up, the technician verified there was no patient involved, therefore no harm.A new function board has been installed and the 2008t machine is back in service.The burnt board is being returned for analysis.
Additional Manufacturer Narrative
The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.
Additional Manufacturer Narrative
Plant investigation: the actual device was returned to the manufacturer for physical evaluation.The functional board was received with a damaged label on eeprom (ic20).There are no signs of thermal damage on the function board, eeprom, or on any other components.The eeprom appears to be installed correctly onto the board.The label was removed found sticky residue on the eeprom from the label.Install functional board onto a test machine for testing.The test machine powered on with an ¿eeprom read error¿ alarm.The eeprom was replaced with a ¿known-good¿ eeprom for retesting.The test machine powered on without failures to a mandatory rinse.A mandatory rinse was completed without any failures or damage to the eeprom.Dialysis mode functioned properly without failures or damage to the eeprom.Self-test program was completed without failures.The initial report of "burnt" component was not verified, although the function board was found to be faulty.
Event or Problem Description
A biomedical technician reported an out of box failure for a function board.The function board was installed and there was a low flow error message with an audible alarm.The technician found the function board eeprom burnt.Another board was ordered.In a follow up, the technician verified there was no patient involved, therefore no harm.A new function board has been installed and the 2008t machine is back in service.The burnt board is being returned for analysis.

• Brand Name: 2008T HEMODIALYSIS SYSTEM WITHOUT CDX
• Common Device Name: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): CONCORD MANUFACTURING; director, quality systems; 4040 nelson avenue; concord CA 94520
• Manufacturer (Section G): CONCORD MANUFACTURING; director, quality systems; 4040 nelson avenue; concord CA 94520
• Manufacturer Contact: jessica trujillo ; 920 winter st; waltham, MA 02451 ; 6174175172
• MDR Report Key: 18575143
• Report Number: 0002937457-2024-00142
• Device Sequence Number: 8914690
• Product Code: KDI
• UDI-Device Identifier: 00840861100903
• UDI-Public: 00840861100903
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K150708
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/19/2024

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
• Operator of Device: Health Professional
• Device Catalogue Number: 190858
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Device Age: MO
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/11/2024
• Supplement Date Received by Manufacturer: 02/08/2024
• Initial Report FDA Received Date: 01/24/2024
• Supplement Report FDA Received Date: 02/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/26/2013
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown