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

Model Number 190828

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Dizziness (2194); Numbness (2415)

Event Date 04/11/2022

Event Type  Injury  

Event Description

It was reported to fresenius that this home hemodialysis patient was in treatment utilizing the 2008k@home hemodialysis machine when they began feeling unwell.The patient complained of dizziness and numbness in the left leg.The event occurred at approximately 1514 hours (15 minutes after the start of treatment) after the patient received a high venous pressure alarm.The patient¿s blood was returned.The paramedics were called, and the patient was transported to the hospital.Additional follow-up yielded limited information related to the event.The patient was admitted to the hospital.The patient was transitioned to in-center hemodialysis and discontinued use of the home hemodialysis machine.No additional details were available related to the patient¿s hospital course or date of discharge.An evaluation of the machine on 13/apr/2022 found the venous and arterial transducer pressures to measure as expected with no leakage observed.Additionally, the pressure and alarm tests passed, and the electrical safety check was carried out successfully.Furthermore, the blood pressure module and cuffs were found to be working as expected.

Manufacturer Narrative

Plant investigation: no parts were returned to the manufacturer for physical evaluation.The machine was evaluated (technician unknown) and found to be operating as expected.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.

• Brand Name: 2008K@HOME HEMODIALYSIS SYSTEM
• Type of Device: HEMODIALYSIS SYSTEM FOR HOME USE
• 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: jason busch ; 920 winter st; waltham, MA 02451 ; 9043166958
• MDR Report Key: 14251875
• MDR Text Key: 290397910
• Report Number: 0002937457-2022-00709
• Device Sequence Number: 1
• Product Code: ONW
• UDI-Device Identifier: 00840861100941
• UDI-Public: 00840861100941
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K070049
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 04/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/29/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 190828
• Device Catalogue Number: 190828
• Device Lot Number: 2K0S177626
• Was Device Available for Evaluation?: Yes
• Device Age: MO
• Date Manufacturer Received: 04/11/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/12/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Female