MAUDE Adverse Event Report: CONCORD MANUFACTURING 2008T HD SYS. CDX W/BIBAG BLUE STAR; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Model Number 191126

Device Problems Thermal Decomposition of Device (1071); Melted (1385); Sparking (2595)

Patient Problem No Patient Involvement (2645)

Event Date 10/29/2020

Event Type  malfunction  

Manufacturer Narrative

Plant investigation: the manufacturer is pending the return of the complaint sample for physical evaluation.A preliminary investigation of quality records was completed.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.A definitive conclusion regarding the complaint incident is pending the return of the complaint sample and a physical evaluation.

Event Description

A fresenius regional equipment specialist (res) reported that a fresenius 2008t hemodialysis (hd) machine had a melted usb cable and a burnt functional board.The res was called onsite by the user facility biomedical technician (biomed) when the machine would not verify a crit-line device.The res removed and reinstalled the machine¿s functional board during troubleshooting, at which point the usb cable melted and the functional board burned.A burning smell and a spark were also observed when the usb cable and the functional board were reconnected.Upon closer inspection, the res found that a connection on the usb cable had broken off, causing the usb cable to melt and the functional board to sustain burn damage.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 machine has approximately 400 hours and the usb cable and functional board were original to the machine.The biomed reported that there was no damage observed on any other components, or any other additional issues, associated with the melted usb cable and the burnt functional board.The biomed replaced the functional board and soldered and taped the usb cable with electrical tape, 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: no parts were returned to the manufacturer for physical evaluation.However, an on-site evaluation was performed by a fresenius field service technician (fst).During the machine inspection, the fresenius fst observed a burning smell and a spark as well as identified burn damage to the functional board and evidence of melting.To resolve the reported issue, the fst replaced the functional board and soldered and taped the usb cable with electrical tape.Therefore, the complaint event was confirmed.

• Brand Name: 2008T HD SYS. CDX W/BIBAG BLUE STAR
• 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: 10853137
• MDR Text Key: 216651505
• Report Number: 2937457-2020-02085
• Device Sequence Number: 1
• Product Code: KDI
• UDI-Device Identifier: 00840861102099
• UDI-Public: 00840861102099
• Combination Product (y/n): N
• PMA/PMN Number: K173972
• 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: 12/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 191126
• Device Catalogue Number: 191126
• Was Device Available for Evaluation?: No
• Device Age: MO
• Initial Date Manufacturer Received: 10/30/2020
• Initial Date FDA Received: 11/17/2020
• Supplement Dates Manufacturer Received: 11/23/2020
• Supplement Dates FDA Received: 12/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1