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

Catalog Number 190766

Device Problems Thermal Decomposition of Device (1071); Smoking (1585)

Patient Problem No Patient Involvement (2645)

Event Date 06/04/2018

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 biomedical technician (biomed) reported that the power supply on a fresenius 2008t hemodialysis (hd) machine was smoking.It was reported that there was black soot noticed where the smoke was emulating from due to the resistor on the power control board of the power supply being burned.The reported event was discovered prior to use when the machine was plugged in and turned on.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 reported there was no damage on any other component associated with the event.The machine has not had any past problems with failing the electrical leakage test and that the machine is plugged into a hospital grade ground-fault circuit interrupter (gfci) outlet.The machine has 12 hours and the power supply is the original fresenius part.A fresenius regional equipment specialist (res) performed an on-site evaluation of the machine.The power supply was replaced by the res to resolve the machine issue.Following part replacement, the res performed functional checks and confirmed the machine was operating properly.The biomed confirmed that the machine is back in service without issue and without reoccurrence of the reported event.The complaint device was reported to be available to be returned to the manufacturer for physical evaluation.

Manufacturer Narrative

Plant investigation: no parts were returned to the manufacturer for physical evaluation.The 2008t hemodialysis (hd) machine was evaluated at the facility by the fresenius regional equipment specialist (res) due to a burned power plug.The res replaced the power supply to resolve the machine issue.After the repairs, machine functional checks were performed, and all tests found the unit to be functioning within specification.A records review was performed on the reported device serial number.An investigation of the device manufacturing records was conducted by the manufacturer.There were no non-conformances, or any associated rework during the manufacturing process which could be related to the reported event.Additionally, a review of the device history record (dhr) confirmed the results of the in-progress and final quality control (qc) testing met all the requirements.The investigation into the cause of the complaint was able to confirm the reported event.

• Brand Name: 2008T HEMODIALYSIS SYSTEM W/BIBAG
• Type of Device: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): CONCORD MANUFACTURING; 4040 nelson avenue; concord CA 94520
• MDR Report Key: 7602260
• MDR Text Key: 111156269
• Report Number: 2937457-2018-01700
• Device Sequence Number: 1
• Product Code: KDI
• UDI-Device Identifier: 00840861100910
• UDI-Public: 00840861100910
• Combination Product (y/n): N
• PMA/PMN Number: K121341
• 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: 08/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/14/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 190766
• Was Device Available for Evaluation?: Yes
• Device Age: MO
• Date Manufacturer Received: 08/22/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1