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 06/13/2022

Event Type  malfunction  

Manufacturer Narrative

The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity. .

Event Description

A biomedical technician (biomed) at a user facility reported that a fresenius 2008t hemodialysis (hd) machine had a motherboard that shorted out.The air-conditioning was down and not working at the clinic, and due to the weather being so hot, there was a lot of moisture building up.Somehow, moisture had dripped down to the motherboard, causing it to short out and, in turn, alarmed a ¿bibag: door error¿ message.The moisture left a discoloration mark on the board, but the biomed was not sure if that mark was a burn mark or a charred mark.The biomed confirmed the part seized out and would no longer work.A patient was not connected to the machine at the time of the incident and there was no harm to any patients or individuals because of this malfunction.The biomed stated that he did not observe any burning smell, smoke, spark, flame, arcing, or any other visible heat or electrical damage related to burn damage found on the motherboard.The biomed stated that the machine has approximately 20,000 hours and that the motherboard is the original fresenius part on the machine.(b)(6) stated that the motherboard was replaced, which resolved the machine issue, and that the machine is back in service without any issues.Additionally, (b)(6) confirmed that there was no damage observed on any other components, or any other additional issues, associated with the burned motherboard.The biomed confirmed that the motherboard was discarded and unavailable for return to the manufacturer for physical evaluation.

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).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 manufacturer determined a causal relationship between the objective evidence and the alleged event.Therefore, the reported event has been confirmed.

Event Description

A biomedical technician (biomed) at a user facility reported that a fresenius 2008t hemodialysis (hd) machine had a motherboard that shorted out.The air-conditioning was down and not working at the clinic, and due to the weather being so hot, there was a lot of moisture building up.Somehow, moisture had dripped down to the motherboard, causing it to short out and, in turn, alarmed a ¿bibag: door error¿ message.The moisture left a discoloration mark on the board, but the biomed was not sure if that mark was a burn mark or a charred mark.The biomed confirmed the part seized out and would no longer work.A patient was not connected to the machine at the time of the incident and there was no harm to any patients or individuals because of this malfunction.The biomed stated that he did not observe any burning smell, smoke, spark, flame, arcing, or any other visible heat or electrical damage related to burn damage found on the motherboard.The biomed stated that the machine has approximately 20,000 hours and that the motherboard is the original fresenius part on the machine.(b)(6) stated that the motherboard was replaced, which resolved the machine issue, and that the machine is back in service without any issues.Additionally, (b)(6) confirmed that there was no damage observed on any other components, or any other additional issues, associated with the burned motherboard.The biomed confirmed that the motherboard was discarded and unavailable for return to the manufacturer for physical evaluation.

• 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: 14933748
• MDR Text Key: 295350106
• Report Number: 0002937457-2022-01125
• 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
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 07/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/06/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 190766
• Device Catalogue Number: 190766
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Date Manufacturer Received: 07/06/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/09/2016
• 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