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 Temperature Problem (3022)

Patient Problem High Blood Pressure/ Hypertension (1908)

Event Date 06/14/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

While servicing a fresenius 2008t hemodialysis (hd) machine at a user facility on (b)(6) 2018, a regional equipment specialist (res) technician reported a machine showing high temperatures in on line clearance test mode during treatment.The res technician reported that the issue could not be duplicated when he serviced the machine, and confirmed the machine passed all functional tests and returned to service.The res technician reported that at the time the high temperature issue occurred, the patient on the machine became hypertensive and was taken off the machine.

Manufacturer Narrative

Plant investigation: no parts were returned to the manufacturer for physical evaluation.An on-site evaluation was performed by a fresenius regional equipment specialist (res), who reported that the issue could not be duplicated, and confirmed that the machine passed all functional tests and returned to service.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 identified 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: 7637101
• MDR Text Key: 112296987
• Report Number: 2937457-2018-01786
• Device Sequence Number: 1
• Product Code: KDI
• UDI-Device Identifier: 00840861100897
• UDI-Public: 00840861100897
• Combination Product (y/n): N
• PMA/PMN Number: K093902
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,user facility
• Type of Report: Initial,Followup
• Report Date: 07/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/26/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 190713
• Was Device Available for Evaluation?: No
• Device Age: MO
• Date Manufacturer Received: 07/23/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: FRESENIUS BLOODLINES; FRESENIUS BLOODLINES