MAUDE Adverse Event Report: CONCORD MANUFACTURING 2008T HEMODIALYSIS SYS., WITH CDX; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Model Number 190713

Device Problem Thermal Decomposition of Device (1071)

Patient Problem No Patient Involvement (2645)

Event Date 01/14/2021

Event Type  malfunction  

Manufacturer Narrative

Plant investigation: the plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.¿.

Event Description

A biomedical technician (biomed) at a user facility reported that three valves on the balancing chamber of a fresenius 2008t hemodialysis (hd) machine sustained burned damage.The issue was first noticed at the beginning of the day when the machine was powered on and produced a burning smell and alarmed with a flow inlet error during rinse.A patient was not connected to the machine at the time of the incident and there was no harm to any patients or individuals because of this malfunction.Upon troubleshooting, the biomed was able to reproduce the burning smell and found that three valves on top of the balancing chamber appeared burned, charred, and blackened.It was confirmed that the three burned valves on the balancing chamber were the original fresenius parts on the machine.The biomed reported that there was no damage observed on any other components, or any other additional issues, associated with the three burned balancing chamber valves.The biomed replaced the three burned balancing chamber valves, which resolved the issue.The unit was returned to service at the user facility without issue and without reoccurrence of the event.The complaint samples are available to be returned to the manufacturer for physical evaluation.

Manufacturer Narrative

Plant investigation: although it was stated that the complaint device was available to be returned, to date no parts were returned to the manufacturer for physical evaluation.Additionally, no on-site evaluation was 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 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: 2008T HEMODIALYSIS SYS., WITH CDX
• Type of Device: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): CONCORD MANUFACTURING; director, quality systems; 4040 nelson avenue; concord CA 94520
• MDR Report Key: 11250902
• MDR Text Key: 229323544
• Report Number: 2937457-2021-00155
• Device Sequence Number: 1
• Product Code: KDI
• UDI-Device Identifier: 00840861100897
• UDI-Public: 00840861100897
• Combination Product (y/n): N
• PMA/PMN Number: K093902
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 02/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/29/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 190713
• Device Catalogue Number: 190713
• Was Device Available for Evaluation?: No
• Device Age: MO
• Date Manufacturer Received: 02/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1