MAUDE Adverse Event Report: CONCORD MANUFACTURING 2008T HEMODIALYSIS SYS., WITH CDX; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Model Number 190713

Device Problem Sparking (2595)

Patient Problem No Patient Involvement (2645)

Event Date 11/25/2020

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 field service technician (fst).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 user facility biomedical technician (biomed) reported sparking coming from a fresenius 2008t hemodialysis (hd) machine.The biomed was performing troubleshooting on the hd system which was pulled from service due to a low flow error and high conductivity alarm.During the biomed¿s initial inspection, they noticed the deaeration pump was not running.Therefore, the biomed started by rebuilding the deaeration pump.After completing the rebuild, the biomed plugged the pump into the distribution board and observed sparking coming from the board, where the deaeration pump pins connect.To isolate the issue, the biomed then replaced the deaeration pump and the distribution board.Both parts were reportedly known, good parts.When the biomed proceeded to plug the deaeration pump into the distribution board, once again, they observed sparking.At this point, the biomed contacted technical support (ts) for further assistance.As advised by ts, the biomed replaced the actuator test board and actuator cable, in addition to the deaeration pump and distribution board (for a second time).Completing these repairs resolved the reported issue.According to the biomed, there was no burning smell, smoke, melting, or arcing.The biomed also confirmed there were no flames.The biomed did not know how many hours were on the machine.No damage was identified on any other components.The machine was plugged into a hospital grade ground-fault circuit interrupter (gfci) outlet, and there was no previous history of the machine failing the electrical leakage test.The biomed confirmed the hd machine was returned to service.The faulty parts were discarded; no samples were available to be returned for evaluation.There was no patient involvement associated with the reported event.

• Brand Name: 2008T HEMODIALYSIS SYS., WITH CDX
• Type of Device: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): CONCORD MANUFACTURING; director, quality systems; 4040 nelson avenue; concord CA 94520
• Manufacturer (Section G): CONCORD MANUFACTURING; director, quality systems; 4040 nelson avenue; concord CA 94520
• Manufacturer Contact: matthew amaral ; 920 winter st; waltham, MA 02451 ; 7816999758
• MDR Report Key: 11012816
• MDR Text Key: 221785332
• Report Number: 2937457-2020-02254
• Device Sequence Number: 1
• Product Code: KDI
• UDI-Device Identifier: 00840861100897
• UDI-Public: 00840861100897
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K093902
• 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
• Report Date: 12/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 190713
• Device Catalogue Number: 190713
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Date Manufacturer Received: 11/25/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/31/2013
• 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