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

Catalog Number	191124
Medical Device Problem Code	Thermal Decomposition of Device (1071)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/14/2024
Type of Reportable Event	Malfunction
Event or Problem Description
A user facility biomedical technician (biomed) reported to fresenius technical services that the 2008t machine experienced low temperature during heat disinfection.There were no diagnostic messages or audible alarms expected.The exact temperature was not provided but it was reported that the temperature would not rise past 25°c on the external meter during the temperature control calibration.Upon initial follow-up, the biomed stated the machine was placed into heat disinfection and suddenly stopped.Upon troubleshooting, a burnt wire was identified on the bicarbonate (bicarb) pump.During further follow-up, the biomed stated the ribbon cable on the acid and bicarbonate pumps were cindered.There was no reported burning smell, smoke, spark, flame, or arcing.The acid and bicarbonate pumps were replaced to resolve the identified thermal damage.The actuator and functional boards were also replaced to restore functionality to the acid and bicarb pumps, respectively.The loading pressure valve was replaced for being noisy.Upon further follow-up the biomed stated that replacing the heater resolved the initial low temperature issue.The machine passed functional testing and was returned to service following repair.No parts were reported to be available to be returned to the manufacturer for physical evaluation.
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: no parts were returned to the manufacturer for physical evaluation.Additionally, no on-site evaluation was performed by a fresenius field service technician (fst).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 non-conformances, or any associated rework identified during the manufacturing process which could be related to the reported event.In addition, the device history record (dhr) review confirmed the results of the in-progress and final quality control (qc) testing met all requirements.The complaint investigation found objective evidence indicating a product problem, thus the complaint is confirmed.
Event or Problem Description
A user facility biomedical technician (biomed) reported to fresenius technical services that the 2008t machine experienced low temperature during heat disinfection.There were no diagnostic messages or audible alarms expected.The exact temperature was not provided but it was reported that the temperature would not rise past 25°c on the external meter during the temperature control calibration.Upon initial follow-up, the biomed stated the machine was placed into heat disinfection and suddenly stopped.Upon troubleshooting, a burnt wire was identified on the bicarbonate (bicarb) pump.During further follow-up, the biomed stated the ribbon cable on the acid and bicarbonate pumps were cindered.There was no reported burning smell, smoke, spark, flame, or arcing.The acid and bicarbonate pumps were replaced to resolve the identified thermal damage.The actuator and functional boards were also replaced to restore functionality to the acid and bicarb pumps, respectively.The loading pressure valve was replaced for being noisy.Upon further follow-up the biomed stated that replacing the heater resolved the initial low temperature issue.The machine passed functional testing and was returned to service following repair.No parts were reported to be available to be returned to the manufacturer for physical evaluation.

• Brand Name: 2008T HD SYS. CDX BLUE STAR
• 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: 20053826
• Report Number: 0002937457-2024-01217
• Device Sequence Number: 7971161
• Product Code: KDI
• UDI-Device Identifier: 00840861102082
• UDI-Public: 00840861102082
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K173972
• 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: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 01/02/2025

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: Other
• Device Catalogue Number: 191124
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/16/2024
• Supplement Date Received by Manufacturer: 12/30/2024
• Initial Report FDA Received Date: 08/23/2024
• Supplement Report FDA Received Date: 01/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/02/2019
• 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