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 11/23/2020

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 two wires on the transformer of a fresenius 2008t hemodialysis (hd) machine appeared burned.The burned wires were found during troubleshooting after the machine experienced issues powering on.The biomed stated that after pressing the power button, the power supply fan would begin to run but the rest of the machine would remain off.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.Additional information was requested, however, to date a response has not been received.It was not reported by the biomed during the initial call that there was any damage observed on any other components, or any other additional issues, associated with the burned wires on the transformer.No parts were returned to the manufacturer for physical evaluation.

Manufacturer Narrative

Plant investigation: the power supply was returned to the manufacturer for physical evaluation.A visual inspection revealed one of the cables from the transformer to the rectifier is frayed with exposed wires and the end connector is found to be charred.There are no other components nearby that are damaged or charred.An inspection on the power control board and power plug found no signs of damage.The power supply (as-received condition) was installed onto a test machine to test for the reported failure.The test machine does not power on with the returned power supply installed.The power supply was removed for troubleshooting.The transformer was replaced with a ¿known-good¿ transformer on the returned power supply.Afterwards, the power supply was reinstalled onto the test machine for retesting.There was no problems during power up.Dialysis mode functioned properly without failures.Self-test program completed without failures.The physical evaluation of the complaint sample confirmed the reported event.

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 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: 10991365
• MDR Text Key: 220907027
• Report Number: 2937457-2020-02229
• 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,Followup
• Report Date: 02/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2020
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/09/2020
• Device Age: MO
• Date Manufacturer Received: 01/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1