MAUDE Adverse Event Report: CONCORD MANUFACTURING 2008T HEMODIALYSIS SYS., WITH CDX DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Model Number 190713

Device Problem Melted (1385)

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

Event Date 08/16/2021

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 user facility biomedical technician (biomed) reported that a 2008t machine was failing tmp tests. Biomed is still troubleshooting the reported issue and stated the machine is still out of service. The check valve, the dialysate pressure transducer #9, along with a few other parts have been replaced and the venous pressure was calibrated but none of those resolved the reported issue. The tech explained they saw, on top of the balancing chamber, that a valve (possibly a solenoid valve) had melted. Upon follow up, biomed did not observe any burning smell, smoke, spark, flame, arcing, or any other visible heat or electrical damage related to the melting found on the valve. Biomed stated that the machine has approximately 13,000 hours and that the valve is the original fresenius part on the machine. Biomed stated that the entire balance chamber was replaced, however the machine is still failing tmp tests for hi and low, and that the machine is not back in service. Additionally, biomed confirmed that there was no damage observed on any other components. Biomed confirmed that the machine has had not problems with passing electrical leakage tests and is plugged into a hospital grade ground fault circuit interrupter (gfci) outlet. Biomed confirmed that 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. Biomed confirmed that the balance chamber and valve were discarded and are not available for return to the manufacturer for physical evaluation.

• Brand Name: 2008T HEMODIALYSIS SYS., WITH CDX
• 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: 12350614
• MDR Text Key: 267561725
• Report Number: 2937457-2021-01750
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K093902
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 09/09/2021

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 08/20/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 190713
• Device Catalogue Number: 190713
• 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: 09/08/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/31/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse