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 Problem Smoking (1585)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/27/2021

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 display that was flashing on and off during power up. There was smoke coming from the card cage and the machine powered down. Biomed found an ic on the actuator/test board that was cracked and burnt. The machine had no power and was unresponsive when the power button was pressed. Biomed changed the actuator/test board and now the machine powers on but has a blank display. Technical support advised biomed to swap the function board, ui/mics board or display assembly if the audible alarms stop or swap the power supply, boards in the card cage or display assembly if the alarms continue. Additional information was requested, however it was not available.

• 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: jason busch ; 920 winter st; waltham, MA 02451 ; 9043166958
• MDR Report Key: 12758720
• MDR Text Key: 280439883
• Report Number: 2937457-2021-02236
• Device Sequence Number: 1
• Product Code: KDI
• UDI-Device Identifier: 00840861102099
• UDI-Public: 00840861102099
• 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: User Facility,Company Representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup,Followup
• Report Date: 01/21/2022

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 11/07/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 191126
• Device Catalogue Number: 191126
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/05/2021
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Date Manufacturer Received: 01/20/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/27/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse