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	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	06/28/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity. .
Event or Problem Description
A user facility biomedical technician (biomed) reported to fresenius technical services that the 2008t machine rebooted during the patient's hemodialysis (hd) treatment.The machine continually powered down and powered back on without reaching the select program screen.Additional information was obtained during follow-up with the biomed and a user facility registered nurse (rn).The reported issue occurred within the first minute of the patient's hemodialysis (hd) treatment.Blood loss resulted from the reported issue.The patient's blood was returned manually via hand crank to minimize the blood loss.The patient's estimated blood loss (ebl) was not provided.There was no serious injury or required medical intervention that resulted from the reported issue.Treatment was restarted on a different machine and completed successfully.The machine was pulled from service following the reported event.The button pad on the front of the machine was replaced to resolve the reported issue.The machine was returned to service without further issue.No parts were reported to be returned to the manufacturer for physical evaluation.
Additional Manufacturer Narrative
Plant investigation: no parts were returned to the manufacturer for physical evaluation and an on-site evaluation was not 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 rebooted during the patient's hemodialysis (hd) treatment.The machine continually powered down and powered back on without reaching the select program screen.Additional information was obtained during follow-up with the biomed and a user facility registered nurse (rn).The reported issue occurred within the first minute of the patient's hemodialysis (hd) treatment.Blood loss resulted from the reported issue.The patient's blood was returned manually via hand crank to minimize the blood loss.The patient's estimated blood loss (ebl) was not provided.There was no serious injury or required medical intervention that resulted from the reported issue.Treatment was restarted on a different machine and completed successfully.The machine was pulled from service following the reported event.The button pad on the front of the machine was replaced to resolve the reported issue.The machine was returned to service without further issue.No parts were reported to be returned to the manufacturer for physical evaluation.

• 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: 19714844
• Report Number: 0002937457-2024-01005
• Device Sequence Number: 12912722
• Product Code: KDI
• UDI-Device Identifier: 00840861100903
• UDI-Public: 00840861100903
• Combination Product (Y/N): N
• Initial Reporter State: ME
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 08/22/2024

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?: No
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/05/2024
• Supplement Date Received by Manufacturer: 08/22/2024
• Initial Report FDA Received Date: 07/10/2024
• Supplement Report FDA Received Date: 08/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/26/2015
• 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
• Concomitant Medical Products and Therapy/Usage Dates: FRESENIUS BLOODLINES.; FRESENIUS BLOODLINES.; FRESENIUS DIALYZER.; FRESENIUS DIALYZER.
• Patient Age: 58 YR
• Patient Sex: Male
• Patient Weight: 167 KG