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 Problems Thermal Decomposition of Device (1071); Charred (1086)

Patient Problem No Patient Involvement (2645)

Event Date 01/16/2017

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The biomedical technician at the user facility reported that a burning smell emanated from the 2008k2 hemodialysis (hd) machine when the unit was powered on.A visual examination performed by the biomed traced the smell to ic21 on the actuator test board which had burn damage.The biomed replaced the actuator test board and the machine ran fine; however, when the system was placed into heat disinfect, ic33 of the new actuator test board was burnt.Follow-up information revealed that there were no visible flames or smoke; only the burning smell was noted and the visual evidence of excessive heat (charring) to the actuator test boards was observed.No patient was connected to the machine at the time of the incident.No parts are available to be returned to the manufacturer for evaluation.

Event Description

The biomedical technician at the user facility reported that a 2008k2 hemodialysis (hd) machine was pulled from the floor for a flow motor issue.The biomed replaced the flow motor, and then the system was placed into heat disinfect.A burning smell emanated from the unit.The biomed performed a visual examination which traced the smell to burn damage, a small, one inch scorch mark, to ic21 on the actuator test board.The biomed replaced the actuator test board and the machine initially ran fine; however, once the unit was placed back into heat disinfect, ic33 of the new actuator test board was burnt (reference mdr id # 2937457-2017-00106).Further examination revealed damage to the temperature sensors; the wire covering was flaking off which is believed to be the cause of the heat damage to the actuator boards.The biomed replaced the temperature sensors and the actuator board to resolve the issue.Following the parts replacement, the system was restored to full functionality.Functional testing performed by the biomed confirmed the system was operating properly.

Manufacturer Narrative

The device was not returned to the manufacturer for physical evaluation.Additionally, no on-site evaluation of the unit was performed by a fresenius regional equipment specialist (res) and no parts were returned for failure analysis.The biomedical engineer provided follow-up which revealed that a small, one inch scorch mark, was observed on ic21 of the actuator test board.Further examination revealed damage to the temperature sensors; the wire covering was flaking off which is believed to be the cause of the heat damage to the actuator board.The biomed replaced the temperature sensors and the actuator board to resolve the issue.Following the parts replacement, the system was restored to full functionality.Functional testing performed by the biomed confirmed the system was operating properly.The unit has been returned to service at the user facility without issue.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 deviations or non-conformances during the manufacturing process which could be associated with the reported event.In addition, the device history record (dhr) review confirmed the material and process controls were within specification.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: 6273761
• MDR Text Key: 65636537
• Report Number: 2937457-2017-00055
• Device Sequence Number: 1
• Product Code: KDI
• 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,user f
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup,Followup
• Report Date: 02/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/24/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Biomedical Engineer
• Device Model Number: 2008K2
• Device Catalogue Number: 190610
• Other Device ID Number: 00840861100859
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Date Manufacturer Received: 02/24/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/02/2009
• 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