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

Catalog Number 190828

Device Problems Mechanical Problem (1384); Reflux within Device (1522)

Patient Problem No Patient Involvement (2645)

Event Date 06/21/2019

Event Type  malfunction  

Manufacturer Narrative

The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.

Event Description

A user facility biomed technician reported to technical support that a 2008k machine experienced a bag of saline filling up.The saline bag backfill occurred during recirculation.The patient was not connected during recirculation.The biomed reported that there were no quick disconnects on the drain line and that the drain line length and height were within specification.The machine was returned to service without a recurrence of the reported issue.An air separator conductivity cable was changed.

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.

• Brand Name: 2008K@HOME HEMODIALYSIS SYSTEM
• Type of Device: HEMODIALYSIS SYSTEM FOR HOME USE
• Manufacturer (Section D): CONCORD MANUFACTURING; 4040 nelson avenue; concord CA 94520
• MDR Report Key: 8779788
• MDR Text Key: 150712943
• Report Number: 2937457-2019-02103
• Device Sequence Number: 1
• Product Code: ONW
• UDI-Device Identifier: 00840861100941
• UDI-Public: 00840861100941
• Combination Product (y/n): N
• PMA/PMN Number: K070049
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 07/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/11/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 190828
• Was Device Available for Evaluation?: No
• Device Age: MO
• Date Manufacturer Received: 07/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1