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.

• 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
• Manufacturer (Section G): CONCORD MANUFACTURING; director, quality systems; 4040 nelson avenue; concord CA 94520
• Manufacturer Contact: matthew amaral ; 920 winter st; waltham, MA 02451 ; 7816999758
• MDR Report Key: 10853137
• MDR Text Key: 216651505
• Report Number: 2937457-2020-02085
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K173972
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 12/10/2020

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 11/17/2020
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 191126
• Device Catalogue Number: 191126
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Device Age: MO
• Event Location: No Information
• Date Manufacturer Received: 11/23/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/06/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse