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

Model Number 190713

Device Problems Thermal Decomposition of Device (1071); Fire (1245)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/01/2022

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 manufacturer determined during the investigation that there was a causal relationship between the objective evidence and the alleged event; therefore the alleged event is confirmed.

Event Description

A biomedical technician (biomed) at a user facility reported that a fresenius 2008t hemodialysis (hd) machine had a burned actuator board.The burned board was noticed during repair after the machine was pulled from service for making popping noises and a burning smell during power up.The biomed reported the acid pump was incorrectly connected to the actuator board which caused the actuator board to short circuit and burn.A patient was not connected to the machine at the time of the incident and there was no harm to any patients or individuals because of this malfunction.The machine has approximately 30,000 hours.It could not be confirmed whether these parts were the original fresenius parts in the machine.The biomed reported that there was no damage observed on any other components, or any other additional issues, associated with the burned actuator board.The biomed replaced the actuator board as well as the bicarbonate and acid pumps which resolved the issue.The unit was returned to service at the user facility without issue and without reoccurrence of the event.The samples were discarded by the biomed and are not available to be returned to the manufacturer for physical evaluation.

Manufacturer Narrative

Correction: b5 (inclusion of the biomed's statement that a flame could be observed), h6 (medical device problem code).

Event Description

A biomedical technician (biomed) at a user facility reported that a fresenius 2008t hemodialysis (hd) machine had a burned actuator board.The burned board was noticed during repair after the machine was pulled from service for making popping noises and a burning smell during power up.The biomed reported the acid pump was incorrectly connected to the actuator board which caused the actuator board to short circuit and burn.The biomed also reported that a flame was observed.A patient was not connected to the machine at the time of the incident and there was no harm to any patients or individuals because of this malfunction.The machine has approximately (b)(4) hours.It could not be confirmed whether these parts were the original fresenius parts in the machine.The biomed reported that there was no damage observed on any other components, or any other additional issues, associated with the burned actuator board.The biomed replaced the actuator board as well as the bicarbonate and acid pumps which resolved the issue.The unit was returned to service at the user facility without issue and without reoccurrence of the event.The samples were discarded by the biomed and are not available to be returned to the manufacturer for physical evaluation.

• 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: jessica trujillo ; 920 winter st; waltham, MA 02451 ; 6174175172
• MDR Report Key: 15595574
• MDR Text Key: 301648495
• Report Number: 0002937457-2022-01537
• 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: K150708
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 10/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/13/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• 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: 10/20/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/02/2012
• 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