MAUDE Adverse Event Report: CONCORD MANUFACTURING 2008T GEN 2 BIBAG WITHOUT CDX; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Catalog Number	190895
Medical Device Problem Code	Thermal Decomposition of Device (1071)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/09/2023
Type of Reportable Event	Malfunction
Event or Problem Description
A user facility biomedical technician (biomed) reported finding thermal damage on a fresenius 2008t hemodialysis (hd) machine.The biomed was preparing to perform a blue star upgrade on the machine when they noticed a burnt diode on the motherboard.The motherboard was confirmed to be an original fresenius part.No damage was identified on any other components.The biomed did not notice a burning smell.It was confirmed there were no signs of any smoke, sparks, flames, or melted components.The machine had approximately 12,000 hours on it.The machine was plugged into a hospital grade ground-fault circuit interrupter (gfci) outlet and had no previous history of failing the electrical leakage test.To resolve the reported issue, the biomed replaced the motherboard.They were then able to continue with the upgrade.The machine upgrade was completed, and the machine was put back in service.The damaged motherboard was not available to be returned for evaluation as it had been discarded.
Additional Manufacturer Narrative
The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.
Additional Manufacturer Narrative
Correction: h6 (health effect impact code).
Event or Problem Description
A user facility biomedical technician (biomed) reported finding thermal damage on a fresenius 2008t hemodialysis (hd) machine.The biomed was preparing to perform a blue star upgrade on the machine when they noticed a burnt diode on the motherboard.The motherboard was confirmed to be an original fresenius part.No damage was identified on any other components.The biomed did not notice a burning smell.It was confirmed there were no signs of any smoke, sparks, flames, or melted components.The machine had approximately 12,000 hours on it.The machine was plugged into a hospital grade ground-fault circuit interrupter (gfci) outlet and had no previous history of failing the electrical leakage test.To resolve the reported issue, the biomed replaced the motherboard.They were then able to continue with the upgrade.The machine upgrade was completed, and the machine was put back in service.The damaged motherboard was not available to be returned for evaluation as it had been discarded.
Additional Manufacturer Narrative
Plant investigation: no parts were returned to the manufacturer for physical evaluation and an on-site evaluation was not performed by a fresenius field service technician (fst).However, the complaint investigation was able to find objective evidence indicating a product problem.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.Based on the available information, the reported event has been confirmed.
Event or Problem Description
A user facility biomedical technician (biomed) reported finding thermal damage on a fresenius 2008t hemodialysis (hd) machine.The biomed was preparing to perform a blue star upgrade on the machine when they noticed a burnt diode on the motherboard.The motherboard was confirmed to be an original fresenius part.No damage was identified on any other components.The biomed did not notice a burning smell.It was confirmed there were no signs of any smoke, sparks, flames, or melted components.The machine had approximately 12,000 hours on it.The machine was plugged into a hospital grade ground-fault circuit interrupter (gfci) outlet and had no previous history of failing the electrical leakage test.To resolve the reported issue, the biomed replaced the motherboard.They were then able to continue with the upgrade.The machine upgrade was completed, and the machine was put back in service.The damaged motherboard was not available to be returned for evaluation as it had been discarded.

• Brand Name: 2008T GEN 2 BIBAG 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: 18049964
• Report Number: 0002937457-2023-01638
• Device Sequence Number: 7465659
• Product Code: KDI
• UDI-Device Identifier: 00840861100927
• UDI-Public: 00840861100927
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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,Company Representative
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/15/2023

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: Health Professional
• Device Catalogue Number: 190895
• 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: 11/01/2023
• Supplement Date Received by Manufacturer: 11/01/2023; 11/02/2023
• Initial Report FDA Received Date: 11/01/2023
• Supplement Report FDA Received Date: 11/01/2023; 11/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/29/2016
• 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