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

Catalog Number 190713

Device Problem Charred (1086)

Patient Problem No Patient Involvement (2645)

Event Date 01/17/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

A biomedical engineer (biomed) at a user facility reported that the fresenius 2008t hemodialysis (hd) machine had a discolored power plug with evidence of charring between the prongs. This was observed while the machine was off. 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 event. There was no reported burning smell, smoke, spark or flame. The plug was stated to be available to be returned to the manufacturer for physical evaluation.

Manufacturer Narrative

Plant investigation: although it was originally stated that the reported charred power plug was available to be returned to the manufacturer, no parts have been received by the manufacturer for evaluation to date. Additionally, no on-site evaluation of the unit was performed by a fresenius regional equipment specialist (res). A records review was performed on the reported serial number. An investigation of the device manufacturing records was conducted by the manufacturer. There were no non-conformances or any associated rework during the manufacturing process which could be related to the reported event. In addition, the device history record (dhr) review confirmed the results of the in-progress and final quality control (qc) testing met all requirements. The investigation into the cause of the reported problem was not able to be confirmed. A definitive conclusion regarding the complaint incident cannot be reached without a physical examination of the complaint device.

• Brand Name: 2008T HEMODIALYSIS SYS., WITH CDX
• Type of Device: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): CONCORD MANUFACTURING; 4040 nelson avenue; concord CA 94520
• MDR Report Key: 7279719
• MDR Text Key: 100531585
• Report Number: 2937457-2018-00515
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): N
• PMA/PMN Number: K093902
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 03/12/2018

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 02/19/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Catalogue Number: 190713
• Was Device Available for Evaluation?: No

Was the Report Sent to FDA?

• Device Age: MO
• Event Location: No Information
• Date Manufacturer Received: 02/22/2018
• Is This a Reprocessed and Reused Single-Use Device?: No