MAUDE Adverse Event Report: CONCORD MANUFACTURING 2008T HEMODIALYSIS SYSTEM W/BIBAG; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Catalog Number 190766

Device Problem Melted (1385)

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

Event Date 03/05/2024

Event Type  malfunction  

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 a fresenius 2008t machine had no power.The bmt had replaced fuses and was checking the power logic board for voltage which there was none.The bmt was requested to remove the input wires from the power cable from the power switch with the machine unplugged from the wall.The power switch was melted inside and the power cable looked good.The bmt was suggested to replace the power switch.Upon follow-up, the bmt confirmed the reported event.The bmt stated the issue was noted during power up of the machine and confirmed there was no patient involvement.The bmt stated the power switch had appeared to have melted.No smoke, melting, or arcing was noted, and there were no reports of sparks or flames.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 bmt stated the power switch and black and white cable connected to the control board were replaced to resolve the issue.Per bmt the machine has been placed back in service without further issue.The damaged components were discarded and were no longer available to be returned for evaluation.There was no patient involvement associated with the reported event.

Manufacturer Narrative

Plant investigation: no parts were returned to the manufacturer for physical evaluation.Complaint investigation found objective evidence indicating a product problem, thus the complaint is 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.

Event Description

A user facility biomedical technician (bmt) reported a fresenius 2008t machine had no power.The bmt had replaced fuses and was checking the power logic board for voltage which there was none.The bmt was requested to remove the input wires from the power cable from the power switch with the machine unplugged from the wall.The power switch was melted inside and the power cable looked good.The bmt was suggested to replace the power switch.Upon follow-up, the bmt confirmed the reported event.The bmt stated the issue was noted during power up of the machine and confirmed there was no patient involvement.The bmt stated the power switch had appeared to have melted.No smoke, melting, or arcing was noted, and there were no reports of sparks or flames.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 bmt stated the power switch and black and white cable connected to the control board were replaced to resolve the issue.Per bmt the machine has been placed back in service without further issue.The damaged components were discarded and were no longer available to be returned for evaluation.There was no patient involvement associated with the reported event.

Event Description

A user facility biomedical technician (bmt) reported a fresenius 2008t machine had no power.The bmt had replaced fuses and was checking the power logic board for voltage which there was none.The bmt was requested to remove the input wires from the power cable from the power switch with the machine unplugged from the wall.The power switch was melted inside and the power cable looked good.The bmt was suggested to replace the power switch.Upon follow-up, the bmt confirmed the reported event.The bmt stated the issue was noted during power up of the machine and confirmed there was no patient involvement.The bmt stated the power switch had appeared to have melted.No smoke or arcing was noted, and there were no reports of sparks or flames.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 bmt stated the power switch and black and white cable connected to the control board were replaced to resolve the issue.Per bmt the machine has been placed back in service without further issue.The damaged components were discarded and were no longer available to be returned for evaluation.There was no patient involvement associated with the reported event.

• Brand Name: 2008T HEMODIALYSIS SYSTEM W/BIBAG
• 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: 18858078
• MDR Text Key: 337671570
• Report Number: 0002937457-2024-00402
• Device Sequence Number: 1
• Product Code: KDI
• UDI-Device Identifier: 00840861100910
• UDI-Public: 00840861100910
• 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
• Report Date: 04/30/2024

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: 190766
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Initial Date Manufacturer Received: 03/05/2024
• Initial Date FDA Received: 03/07/2024
• Supplement Dates Manufacturer Received: 04/04/2024; 04/29/2024
• Supplement Dates FDA Received: 04/10/2024; 04/30/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/16/2016
• 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