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); Smoking (1585)

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

Event Date 02/01/2022

Event Type  malfunction  

Event Description

A biomedical technician (biomed) at a user facility reported that a fresenius 2008t hemodialysis (hd) machine was displaying an intermittent 24 volt low message in standby prior to treatment.Upon troubleshooting the machine issue, biomed found that the ic23 on the actuator board was burned and there was a burning smell and smoke.Biomed did not observe any spark, flame, arcing, or any other visible heat or electrical damage related to the burning found on the actuator board.Biomed could not confirm the machine hours or if the actuator board was the original fresenius part on the machine.The machine has not had any past problems with failing the electrical leakage test and is always plugged into a hospital grade ground-fault circuit interrupter (gfci) outlet.Biomed stated that the actuator board and cable were replaced, which resolved the machine issue, and that the machine is back in service without any issues.Additionally, biomed confirmed that there was damage observed on the actuator board cable associated with the burned ic 23 on the actuator board.Biomed confirmed that 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.Biomed confirmed that the actuator board was discarded and that it is not available for return to the manufacturer for physical evaluation.

Manufacturer Narrative

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

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 biomedical technician (biomed) at a user facility reported that a fresenius 2008t hemodialysis (hd) machine was displaying an intermittent 24 volt low message in standby prior to treatment.Upon troubleshooting the machine issue, biomed found that the ic23 on the actuator board was burned and there was a burning smell and smoke.Biomed did not observe any spark, flame, arcing, or any other visible heat or electrical damage related to the burning found on the actuator board.Biomed could not confirm the machine hours or if the actuator board was the original fresenius part on the machine.The machine has not had any past problems with failing the electrical leakage test and is always plugged into a hospital grade ground-fault circuit interrupter (gfci) outlet.Biomed stated that the actuator board and cable were replaced, which resolved the machine issue, and that the machine is back in service without any issues.Additionally, biomed confirmed that there was damage observed on the actuator board cable associated with the burned ic 23 on the actuator board.Biomed confirmed that 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.Biomed confirmed that the actuator board was discarded and that it is not available for return 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: jason busch ; 920 winter st; waltham, MA 02451 ; 9043166958
• MDR Report Key: 13480703
• MDR Text Key: 285234446
• Report Number: 2937457-2022-00207
• 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: User Facility,Company Representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 02/23/2022

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: 190713
• Device Catalogue Number: 190713
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Initial Date Manufacturer Received: 02/01/2022
• Initial Date FDA Received: 02/08/2022
• Supplement Dates Manufacturer Received: 02/18/2022
• Supplement Dates FDA Received: 02/23/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2017
• 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