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

Model Number 190858

Device Problems Thermal Decomposition of Device (1071); Melted (1385)

Patient Problem No Patient Involvement (2645)

Event Date 01/01/2020

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 biomedical technician (biomed) at a user facility reported that a fresenius 2008t hemodialysis (hd) machine had a wire connecting the rocker switch and the power control board that burned and melted.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.The biomed did not observe any burning smell, smoke, spark, flame, arcing, or any other visible heat or electrical damage related to the rocker switch and the wire.It was also confirmed that there was no damage observed on any other components, or any other additional issues, associated with the rocker switch and the wire.The biomed replaced the rocker switch and the wire to resolve the issue.The unit was returned to service at the user facility without issue and without reoccurrence of the event.The parts were discarded by the biomed and are not available to be returned to the manufacturer for physical evaluation.

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: 2008T HEMODIALYSIS SYSTEM WITHOUT 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: 10806673
• MDR Text Key: 215245241
• Report Number: 2937457-2020-02022
• Device Sequence Number: 1
• Product Code: KDI
• UDI-Device Identifier: 00840861100903
• UDI-Public: 00840861100903
• Combination Product (y/n): N
• PMA/PMN Number: K113427
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 11/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/08/2020
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 190858
• Device Catalogue Number: 190858
• Was Device Available for Evaluation?: No
• Device Age: MO
• Date Manufacturer Received: 11/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1