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

Model Number 2008K2

Device Problem Charred (1086)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/27/2017

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

A user facility reported that a 2008k2 hemodialysis (hd) machine generated a flow inlet error message while a patient underwent their hd treatment.The error was accompanied by a burning smell emanating from the machine.No patient adverse effects were experienced and no medical intervention was required as a result of this event.The patient was moved to another machine, and then the hd treatment was continued and successfully completed without issue.Following the event, the system was removed from service for evaluation.A visual examination performed by the biomed found that the deaeration motor was locked up and the actuator board was damaged.Follow-up was provided by the biomed who clarified the damage observed to the actuator board.Reportedly, charring was visible on the board.The deaeration motor and actuator board were replaced to resolve the issue.Following the parts replacement, the system was restored to full functionality.The unit has been returned to service at the user facility without issue.Although the user facility indicated that the actuator board was available to be returned to the manufacturer for evaluation, it has not been received for analysis.

Manufacturer Narrative

Plant investigation: no parts were returned to the manufacturer for physical evaluation.Additionally, no on-site evaluation of the unit was performed by a fresenius regional equipment specialist (res).The unit was pulled from service for evaluation by the facility biomedical engineer (biomed) following the event.The biomed replaced the deaeration motor and actuator board to resolve the issue.Following parts replacement, the system was confirmed to be operating properly.The unit has been returned to service at the user facility without a recurrence of the event as reported.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 associated with 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: 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
• Manufacturer (Section G): CONCORD MANUFACTURING; 4040 nelson avenue; concord CA 94520
• Manufacturer Contact: thomas c. johnson ; 920 winter st.; waltham, MA 02451 ; 7816999499
• MDR Report Key: 6598942
• MDR Text Key: 76263143
• Report Number: 2937457-2017-00408
• Device Sequence Number: 1
• Product Code: KDI
• UDI-Device Identifier: 00840861100859
• UDI-Public: 00840861100859
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K994267
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 07/06/2017

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 Model Number: 2008K2
• Device Catalogue Number: 190610
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Initial Date Manufacturer Received: 05/10/2017
• Initial Date FDA Received: 05/30/2017
• Supplement Dates Manufacturer Received: 06/14/2017
• Supplement Dates FDA Received: 07/06/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2010
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1