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

Model Number 190858

Device Problem Melted (1385)

Patient Problem No Patient Involvement (2645)

Event Date 03/12/2020

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 fresenius field service technician (fst) reported finding heat damage on the power plug of a 2008t machine. The damage was found while the fst was performing a semi-annual preventive maintenance (pm) check. The fst reported there was blackening around one of the prongs and stated that the plastic plug exhibited signs of melting. There was no burning smell, smoke, or arcing noted. In addition, there were no reports of sparks or flames. No damage was identified on any other components. The machine had approximately 9,860 hours on it. When in use, the machine is plugged into a hospital grade ground-fault circuit interrupter (gfci) outlet. There was no previous history of the machine failing the electrical leakage test. The fst replaced the power cord to resolve the reported issue. After the repair was completed, the machine underwent and passed functional testing. The machine has reportedly been returned to service. The damaged part was discarded and was therefore not available to be sent back for physical evaluation. There was no patient involvement associated with the reported event.

• Brand Name: 2008T HEMODIALYSIS SYSTEM WITHOUT 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: 9909996
• MDR Text Key: 194306233
• Report Number: 2937457-2020-00571
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K113427
• 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,Followup
• Report Date: 04/14/2020

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 04/01/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 190858
• Device Catalogue Number: 190858
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Device Age: MO
• Event Location: No Information
• Date Manufacturer Received: 04/14/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/27/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse