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 Backflow (1064)

Patient Problem No Patient Involvement (2645)

Event Date 01/15/2019

Event Type  malfunction  

Manufacturer Narrative

Plant investigation: no parts were returned to the manufacturer for physical evaluation.Additionally, no on-site evaluation 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 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.

Event Description

A biomedical technician (biomed) at a user facility reported that a fresenius 2008t hemodialysis (hd) machine had a saline bag backfill during recirculation mode.The backfill was visually observed by a staff member.The biomed did not report that there were any machine alarms.A patient was not connected to the machine at the time of the incident.The biomed reported that there were no quick disconnects on the drain line and that the drain line length and height were within specification.The biomed advised it was unknown if the saline bag backfill was due to user error.It was confirmed that the unit has received the cbe hardware and software upgrades.The biomed reported he replaced the distribution board and rebuilt the top of the air separator chamber to resolve the issue.The machine is back in service without reoccurrence of the reported event.

Manufacturer Narrative

Additional information.

Manufacturer Narrative

Additional information: additional information: a fresenius regional equipment specialist (res) inspected the machine and verified the cbe upgrade was installed correctly.The res had the clinic staff set up the machine and verified there was no saline backfill.The machine passed all functional tests and returned to service.

Manufacturer Narrative

Updated 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).The res inspected the machine and verified the cbe upgrade was installed correctly.The res had the clinic staff set up the machine and verified there was no saline backfill.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.

• 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: 8284497
• MDR Text Key: 134333344
• Report Number: 2937457-2019-00286
• 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: company representative,user f
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 03/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 01/15/2019
• Initial Date FDA Received: 01/29/2019
• Supplement Dates Manufacturer Received: 01/30/2019; 01/29/2019; 03/07/2019
• Supplement Dates FDA Received: 02/12/2019; 02/14/2019; 03/08/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1