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

Model Number 190766

Device Problem Thermal Decomposition of Device (1071)

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

Event Date 10/19/2022

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 that upon power up a 2008t hemodialysis (hd) machine prompted with a constant alarm and the lcd assembly is dark.The bmt stated they are not getting 5 or 12 volts on the motherboard and found both white wires going to the bridge rectifier were charred in the power supply.The bmt was advised by customer service that those two white wires go to the transformer in power supply and to replace the power supply assembly.The bmt stated the machine remains out of service pending receipt and replacement of the power supply assembly.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 there were an unknown number of hours on the machine at the time of the event.The damaged component was 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.Additionally, no on-site evaluation was performed by a fresenius field service technician (fst).Investigation determines that there was causal relationship between the objective evidence and the alleged event; the alleged event 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 that upon power up a 2008t hemodialysis (hd) machine prompted with a constant alarm and the lcd assembly is dark.The bmt stated they are not getting 5 or 12 volts on the motherboard and found both white wires going to the bridge rectifier were charred in the power supply.The bmt was advised by customer service that those two white wires go to the transformer in power supply and to replace the power supply assembly.The bmt stated the machine remains out of service pending receipt and replacement of the power supply assembly.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 there were an unknown number of hours on the machine at the time of the event.The damaged component was 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: 15661520
• MDR Text Key: 302320154
• Report Number: 0002937457-2022-01770
• 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
• Report Date: 11/11/2022

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: Other
• Device Model Number: 190766
• Device Catalogue Number: 190766
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Initial Date Manufacturer Received: 10/19/2022
• Initial Date FDA Received: 10/24/2022
• Supplement Dates Manufacturer Received: 11/11/2022
• Supplement Dates FDA Received: 11/11/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/28/2015
• 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