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

Model Number	190858
Medical Device Problem Code	Melted (1385)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/08/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Plant investigation: the plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.
Event or Problem Description
A user facility biomedical technician (bmt) reported to technical support that a 2008t machine displayed the flow inlet error message and had a burning smell during heat disinfect mode.He found that plastic around the deaeration motor brushes melted.He recently installed the deaeration motor and ran without issue for multiple treatments.There was no patient involvement, patient harm, or adverse event reported.The biomedical technician stated the machine remains out of service pending decision from the clinic manager.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 deaeration motor component was returned for investigation.
Additional Manufacturer Narrative
Additional information: d9, h3 plant investigation: the actual device was returned to the manufacturer for physical evaluation.The deaeration motor was returned with the 5 pin plug and 5 pin plug cover removed from the wires of the motor.The length of the wires are cut in half.There is no other discrepancies on the motor externally.Assemble deaeration motor and installed onto test machine for testing.No problems during the initial power up.Encountered the reported ¿flow inlet error¿ during dialysis.Burning smell was not encountered during testing.An internal inspection on the deaeration motor shows one of the motor brushes is stuck onto the surface of the surrounded plastic housing.The surrounded plastic housing and motor brush is deformed and damaged.The brushes must contact the commutator in order for the motor to function properly.There are no signs of heat damage internally.A review of the device manufacturing records was conducted by the manufacturer.There were no deviations or non-conformances during the manufacturing process.In addition, a device history record (dhr) review was performed and verified that the results of the in-progress and final quality control (qc) testing met all requirements.Upon completion of the evaluation, the reported issue was confirmed and the cause was determined to be traced to the deformation of the plastic housing and motor brush.
Event or Problem Description
A user facility biomedical technician (bmt) reported to technical support that a 2008t machine displayed the flow inlet error message and had a burning smell during heat disinfect mode.He found that plastic around the deaeration motor brushes melted.He recently installed the deaeration motor and ran without issue for multiple treatments.There was no patient involvement, patient harm, or adverse event reported.The biomedical technician stated the machine remains out of service pending decision from the clinic manager.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 deaeration motor component was returned for investigation.

• Brand Name: 2008T HEMODIALYSIS SYSTEM WITHOUT CDX
• Common Device Name: 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: 14658198
• Report Number: 0002937457-2022-00938
• Device Sequence Number: 3739191
• Product Code: KDI
• UDI-Device Identifier: 00840861100903
• UDI-Public: 00840861100903
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K150708
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 01/09/2023

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
• Operator of Device: Other
• Device Model Number: 190858
• Device Catalogue Number: 190858
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/08/2022
• Supplement Date Received by Manufacturer: 01/04/2023
• Initial Report FDA Received Date: 06/10/2022
• Supplement Report FDA Received Date: 01/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/19/2015
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown