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

Catalog Number 190713

Device Problems Thermal Decomposition of Device (1071); Melted (1385); Smoking (1585)

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

Event Date 02/20/2024

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 user facility biomedical technician (biomed) contacted fresenius technical support (ts) for troubleshooting assistance with a 2008t hemodialysis (hd) machine with unspecified temperature issues.The biomed reportedly touched pins 7 and 9 together on the power logic board and it blew t5.The ts representative advised them to swap the function board.Additional details were provided upon follow-up another biomed who had assisted the reporting biomed with the troubleshooting.They originally thought the function board was not communicating effectively with the heater board, failing to tell it to turn on.They also noticed there was corrosion present on the function board.They replaced the function board, but then the actuator board stopped receiving data.While continuing to troubleshoot with ts, they touched pins 7 and 9 together from the power logic board and it blew t5.They could see that the wire had melted off the resistor.This thermal damage was admittedly caused by use error, as the troubleshooting guide specifically warns against touching these two pins together.When the pins touched, a burning smell was noticed, and a tiny poof of smoke was emitted.There were no sparks or flames, and the smoke was not significant enough to set off the smoke detector.After this occurred, they replaced the power logic board.This resolved the issue of the actuator board not receiving data, but t5 blew again.At this point, ts advised the biomed's to replace the power supply.They replaced the power supply, and the machine became fully operational again.The machine had 18,106 operating hours on it at the time of the event.It was confirmed the machine was plugged into a hospital grade ground-fault circuit interrupter (gfci) outlet and had no previous history of failing the electrical leakage test.The damaged power logic boards and the function board were all discarded.The bad power supply was reportedly being sent back for evaluation.No photos of the damaged parts were available.There was no patient involvement associated with the events.

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).However, the complaint investigation found objective evidence indicating a product problem, and thus the complaint was confirmed.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 able to be confirmed.The thermal decomposition was admittedly caused by user error which blew t5.

Event Description

A user facility biomedical technician (biomed) contacted fresenius technical support (ts) for troubleshooting assistance with a 2008t hemodialysis (hd) machine with unspecified temperature issues.The biomed reportedly touched pins 7 and 9 together on the power logic board and it blew t5.The ts representative advised them to swap the function board.Additional details were provided upon follow-up with another biomed who had assisted the reporting biomed with the troubleshooting.They originally thought the function board was not communicating effectively with the heater board, failing to tell it to turn on.They also noticed there was corrosion present on the function board.They replaced the function board, but then the actuator board stopped receiving data.While continuing to troubleshoot with ts, they touched pins 7 and 9 together from the power logic board and it blew t5.They could see that the wire had melted off the resistor.This thermal damage was admittedly caused by use error, as the troubleshooting guide specifically warns against touching these two pins together.When the pins touched, a burning smell was noticed, and a tiny poof of smoke was emitted.There were no sparks or flames, and the smoke was not significant enough to set off the smoke detector.After this occurred, they replaced the power logic board.This resolved the issue of the actuator board not receiving data, but t5 blew again.At this point, ts advised the biomeds to replace the power supply.They replaced the power supply, and the machine became fully operational again.The machine had 18,106 operating hours on it at the time of the event.It was confirmed the machine was plugged into a hospital grade ground-fault circuit interrupter (gfci) outlet and had no previous history of failing the electrical leakage test.The damaged power logic boards and the function board were all discarded.The bad power supply was reportedly being sent back for evaluation.No photos of the damaged parts were available.There was no patient involvement associated with the events.

• 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: 18883683
• MDR Text Key: 337402015
• Report Number: 0002937457-2024-00421
• 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: 04/01/2024

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: Other
• Device Catalogue Number: 190713
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Initial Date Manufacturer Received: 02/20/2024
• Initial Date FDA Received: 03/12/2024
• Supplement Dates Manufacturer Received: 03/25/2024
• Supplement Dates FDA Received: 04/01/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/06/2014
• 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