MAUDE Adverse Event Report: CONCORD MANUFACTURING 2008K2 HEMODIALYSIS SYS. OLC/DIASAFE PLS; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Catalog Number 190610

Device Problem Backflow (1064)

Patient Problem No Patient Involvement (2645)

Event Date 01/07/2019

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 biomedical technician (biomed) at a user facility reported that a fresenius 2008k2 hemodialysis (hd) machine had a saline bag backfill during set-up for use.The backfill was visually observed.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 believes the saline bag backfill was not due to user error.It was confirmed that the unit has received the cbe hardware and software upgrades.The biomed advised he was waiting a replacement part to upgrade the actuator board to resolve the issue.The biomed advised the machine was presently out of service.It was confirmed there were no parts available to be returned to the manufacturer.

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 confirmed that the air separator adapter board and enhanced back-flow prevention were installed correctly.The res confirmed the clinic biomed had already replaced the air separator and confirmed the machine had been used since the air separator had been replaced, and was used prior to the res inspecting it.The rres confirmed the machine passed functional checks and functioned without error.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.

Manufacturer Narrative

Additional information: a fresenius regional equipment specialist (res) inspected the machine for the cbe upgrade verification.The res verified the air separator adapter board and enhanced back-flow prevention were installed correction.The res confirmed the clinic biomedical technician had already replaced the air separator and had been in use since the air separator was replaced by the biomedical technician.The res confirmed the machine had 9519 hours of use.The res confirmed the machine passed functional checks, and functioned without error in patient use and upon verification.

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.

Manufacturer Narrative

Additional information: the plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity. .

Event Description

A follow up service confirmation was received regarding the machine.A fresenius regional equipment specialist (res) inspected the machine for the cbe upgrade verification.The res verified the air separator adapter board and enhanced back flow prevention were installed correctly.The res confirmed the clinic biomedical technician replaced the air separator and confirmed the machine had been in use since the air separator was replaced.The res confirmed the machine functioned without error in patient use and upon verification.The res confirmed the machine passed all functional tests.

• Brand Name: 2008K2 HEMODIALYSIS SYS. OLC/DIASAFE PLS
• 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: 8260733
• MDR Text Key: 133525562
• Report Number: 2937457-2019-00202
• Device Sequence Number: 1
• Product Code: KDI
• UDI-Device Identifier: 00840861100859
• UDI-Public: 00840861100859
• Combination Product (y/n): N
• PMA/PMN Number: K994267
• 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,Followup
• Report Date: 02/06/2019

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: 190610
• Was Device Available for Evaluation?: Yes
• Device Age: MO
• Initial Date Manufacturer Received: 01/07/2019
• Initial Date FDA Received: 01/18/2019
• Supplement Dates Manufacturer Received: 01/18/2019; 01/23/2019; 01/28/2019; 02/04/2019
• Supplement Dates FDA Received: 01/22/2019; 01/28/2019; 01/31/2019; 02/06/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1