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

Model Number	190828
Medical Device Problem Code	Inadequate Ultra Filtration (1656)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/12/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Plant investigation: no parts were returned to the manufacturer for physical evaluation.Additionally, there were no issues found during completion of the ultrafiltration (uf) problem identification checklist.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
A home hemodialysis (hd) patient reported to fresenius medical care (b)(4) that their 2008k@home hd machine was removing too much fluid during treatment.The ultrafiltration (uf) problem identification checklist was completed by an fmc canada technician, and no problems were found.The patient stated they would continue to use the machine and report any further issues.Through multiple follow-up attempts with fmc canada, no additional information could be obtained.The technical representative from canada was unable to reach the patient for more information.However, the uf problem checklist provided at intake indicates the 2008k@home machine passed all tests.The technician stated they ¿believe the patient was doing something wrong when weighing [themselves] and has not had any issues since then¿.There were no reports of any adverse events.In addition, there was no indication that any parts had to be replaced or calibrated.

• Brand Name: 2008K@HOME HEMODIALYSIS SYSTEM
• Common Device Name: HEMODIALYSIS SYSTEM FOR HOME USE
• Manufacturer (Section D): CONCORD MANUFACTURING; director, quality systems; 4040 nelson avenue; concord CA 94520
• MDR Report Key: 11631988
• Report Number: 2937457-2021-00629
• Device Sequence Number: 3021064
• Product Code: ONW
• UDI-Device Identifier: 00840861100941
• UDI-Public: 00840861100941
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K070049
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/07/2021

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: 190828
• Device Catalogue Number: 190828
• Was Device Available for Evaluation?: No
• Device Age: MO
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/19/2021
• Initial Report FDA Received Date: 04/07/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1