MAUDE Adverse Event Report: CONCORD MANUFACTURING 2008K@HOME HEMODIALYSIS SYSTEM W/ BIBAG; HEMODIALYSIS SYSTEM FOR HOME USE

Model Number	2008K@HOME
Medical Device Problem Code	Inadequate Ultra Filtration (1656)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/13/2018
Type of Reportable Event	Malfunction
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 regional equipment specialist (res).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 investigation into the cause of the reported problem was not able to be confirmed.A definitive conclusion regarding the complaint incident cannot be reached without a physical examination of the complaint device.
Event or Problem Description
Hemodialysis clinic contact reported that the customer reports a low ultra filtration removal during treatment.Follow up with the clinic indicates that the patient did not require medical intervention.The uf goal was 3.0 but the machine pulled 1.5.However, the patient lost weight during the last checkup.The biomed technician was scheduled to test the machine with simulation treatments.There was no reported malfunction or alarms to the machine.Additional information solicited.

• Brand Name: 2008K@HOME HEMODIALYSIS SYSTEM W/ BIBAG
• Common Device Name: HEMODIALYSIS SYSTEM FOR HOME USE
• Manufacturer (Section D): CONCORD MANUFACTURING; 4040 nelson avenue; concord CA 94520
• MDR Report Key: 7823872
• Report Number: 2937457-2018-02502
• Device Sequence Number: 11086067
• Product Code: ONW
• UDI-Device Identifier: 00840861100965
• UDI-Public: 00840861100965
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K124035
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 08/28/2018

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
• Operator of Device: Lay User/Patient
• Device Model Number: 2008K@HOME
• Device Catalogue Number: 190904
• Was Device Available for Evaluation?: No
• Device Age: MO
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/13/2018
• Initial Report FDA Received Date: 08/28/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1