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

Model Number 190766

Device Problems Thermal Decomposition of Device (1071); Melted (1385); Smoking (1585)

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

Event Date 02/28/2022

Event Type  malfunction  

Manufacturer Narrative

The plant investigation is in process. A supplemental mdr will be submitted upon completion of this activity.  .

Event Description

Biomedical technician (biomed) at a user facility reported that a fresenius 2008t hemodialysis (hd) machine began to smoke and smell and then powered off 10 minutes prior to the completion of a patient¿s treatment. The machine was pulled from service and the cause of the event was traced to a melted valve (#105). The machine has approximately 14,652 hours and the valve was the original fresenius part on the machine. The biomed reported that there was no damage observed on any other components, or any other additional issues, associated with valve 105. The biomed replaced valve 105, which resolved the issue, as well as the bibag assembly during the course of troubleshooting. Follow-up with the user facility clinical manager (cm) confirmed that the patient did not experience a serious injury, adverse event, or require medical intervention as a result of the reported issue. The patient completed treatment approximately 10 minutes early and was able to be reinfused to prevent blood loss. The unit was repaired but remains out of service pending bleach disinfection. The valve is available to be returned to the manufacturer for physical evaluation.

• Brand Name: 2008T HEMODIALYSIS SYSTEM W/BIBAG
• 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: 13662304
• MDR Text Key: 286641137
• Report Number: 2937457-2022-00343
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K121341
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 04/08/2022

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 03/03/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 190766
• Device Catalogue Number: 190766
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Date Manufacturer Received: 03/28/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/26/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse