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 Patient Involvement (2645)

Event Date 01/15/2020

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 experienced a low flow error in dialysis mode. Upon follow up with the biomed, it was reported that the issue was resolved by replacing four balancing chamber valves. During the repair, the biomed noted that one of the balancing chamber valves was bulging and cracked open on the side. The biomed stated there was a large bulge of melted plastic stuck to the outside of the valve. There was no report of a burning smell, sparks, or flames. The used parts were discarded, and therefore, not available to be returned for evaluation. Photo evidence of the damage could not be provided upon request. No damage was identified on any other components. The biomed confirmed there was no previous history of the machine failing the electrical leakage test. After completing the repair, the biomed confirmed that the machine was returned to service. There was no patient involvement associated with the reported event.

• 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: 9701378
• MDR Text Key: 193106255
• Report Number: 2937457-2020-00304
• 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: company representative,user f
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 02/17/2020

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 02/12/2020
• 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: 02/13/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/21/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse