MAUDE Adverse Event Report: CONCORD MANUFACTURING 2008T HD SYS. W/O CDX BLUE STAR; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Catalog Number	191128
Medical Device Problem Code	Thermal Decomposition of Device (1071)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/04/2023
Type of Reportable Event	Malfunction
Event or Problem Description
A user facility reported no power to clic crit-line clip.It was discovered the staff was getting the usb port wet and shorting out the usb and the usb connection on the function board.Both components were replaced and verified operation of the machine.Upon follow-up, the biomedical technician (bmt) reported stated the there were no diagnostic messages or audible alarms.The bmt stated there was no patient involvement, patient harm, or adverse event reported.The bmt stated the function board appeared burnt and confirmed there was no smoke, fire or burning smell as associated with the reported event.The bmt replaced the function board and usb connection to resolve the reported issue.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.The replaced components were available to be returned for investigation.A photo was provided for the investigation.
Additional Manufacturer Narrative
Plant investigation: the plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.
Additional Manufacturer Narrative
Correction: g3 date received for initial submission should have been 08/12/2023.
Event or Problem Description
A user facility reported no power to clic crit-line clip.It was discovered the staff was getting the usb port wet and shorting out the usb and the usb connection on the function board.Both components were replaced and verified operation of the machine.Upon follow-up, the biomedical technician (bmt) reported stated the there were no diagnostic messages or audible alarms.The bmt stated there was no patient involvement, patient harm, or adverse event reported.The bmt stated the function board appeared burnt and confirmed there was no smoke, fire or burning smell as associated with the reported event.The bmt replaced the function board and usb connection to resolve the reported issue.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.The replaced components were available to be returned for investigation.A photo was provided for the investigation.
Event or Problem Description
A user facility reported no power to clic crit-line clip.It was discovered the staff was getting the usb port wet and shorting out the usb and the usb connection on the function board.Both components were replaced and verified operation of the machine.Upon follow-up, the biomedical technician (bmt) reported stated the there were no diagnostic messages or audible alarms.The bmt stated there was no patient involvement, patient harm, or adverse event reported.The bmt stated the function board appeared burnt and confirmed there was no smoke, fire or burning smell as associated with the reported event.The bmt replaced the function board and usb connection to resolve the reported issue.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.The replaced components were available to be returned for investigation.A photo was provided for the investigation.
Additional Manufacturer Narrative
Additional information: d9, h3 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.

• Brand Name: 2008T HD SYS. W/O CDX BLUE STAR
• 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: 17552144
• Report Number: 0002937457-2023-01217
• Device Sequence Number: 6665501
• Product Code: KDI
• UDI-Device Identifier: 00840861102105
• UDI-Public: 00840861102105
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K173972
• 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: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/08/2023

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 Catalogue Number: 191128
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/11/2023
• Supplement Date Received by Manufacturer: 09/06/2023; 09/08/2023
• Initial Report FDA Received Date: 08/15/2023
• Supplement Report FDA Received Date: 09/06/2023; 09/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/09/2020
• 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