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); Sparking (2595)

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

Event Date 06/02/2022

Event Type  malfunction  

Event Description

A user facility reported a hemodialysis (hd) machine prompted with a low temperature alarm during prep mode and the power logic board was replaced because the t5 on the power logic board was burned.It was noted the original issue was the hd machine was not turning on.Technical support (ts) advised that the t5 on power logic board could have damaged by the power control board.There was no patient involvement, patient harm, or adverse event reported.Additional information was requested but was not received to date.

Manufacturer Narrative

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

Event Description

A user facility biomedical technician (bmt) reported to technical support that a 2008t machine had a low temperature alarm during prep mode.There were no diagnostic messages or audible alarms.The biomedical technician stated when the machine was put in heat disinfection mode the machine did not raise the heat and the temperature stayed at 27 degrees.The bmt found the t5 on the power logic board was burnt.There was no patient involvement, patient harm, or adverse event reported.The biomedical technician replaced the power control board and the power logic board to resolve the reported issue.The machine is back in service.There was no patient involvement associated with the reported event.The machine was plugged into a hospital grade ground-fault circuit interrupter (gfci) outlet and does not have a previous history of failing an electrical leakage test.It was reported the replaced components were not available to be returned for investigation.A photo was provided for the investigation.

Event Description

A user facility reported a hemodialysis (hd) machine prompted with a low temperature alarm during prep mode and the power logic board was replaced because the t5 on the power logic board was burned.It was noted the original issue was the hd machine was not turning on.Technical support (ts) advised that the t5 on power logic board could have damaged by the power control board.There was no patient involvement, patient harm, or adverse event reported.Additional information was requested but was not received to date.

Manufacturer Narrative

Medical device problem code.

Event Description

A user facility biomedical technician (bmt) reported to technical support that a 2008t machine had a low temperature alarm during prep mode.There were no diagnostic messages or audible alarms.The biomedical technician stated when the machine was put in heat disinfection mode the machine did not raise the heat and the temperature stayed at 27 degrees.The bmt found the t5 on the power logic board was burnt.There was no patient involvement, patient harm, or adverse event reported.The biomedical technician replaced the power control board and the power logic board to resolve the reported issue.The machine is back in service.There was no patient involvement associated with the reported event.The machine was plugged into a hospital grade ground-fault circuit interrupter (gfci) outlet and does not have a previous history of failing an electrical leakage test.It was reported the replaced components were not available to be returned for investigation.A photo was provided for the investigation.

Manufacturer Narrative

Plant investigation: the component was not returned; a physical investigation was not performed.The reported event was confirmed using the attached photo.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.

Event Description

A user facility biomedical technician (bmt) reported to technical support that a 2008t machine had a low temperature alarm during prep mode.There were no diagnostic messages or audible alarms.The biomedical technician stated when the machine was put in heat disinfection mode the machine did not raise the heat and the temperature stayed at 27 degrees.The bmt found the t5 on the power logic board was burnt.There was no patient involvement, patient harm, or adverse event reported.The biomedical technician replaced the power control board and the power logic board to resolve the reported issue.The machine is back in service.There was no patient involvement associated with the reported event.The machine was plugged into a hospital grade ground-fault circuit interrupter (gfci) outlet and does not have a previous history of failing an electrical leakage test.It was reported the replaced components were not available to be returned for investigation.A photo was provided for the investigation.

• 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: 14630912
• MDR Text Key: 296861911
• Report Number: 0002937457-2022-00911
• 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,Followup,Followup,Followup
• Report Date: 08/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2022
• 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: 08/11/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/31/2017
• 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