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

Model Number 191126

Device Problems Thermal Decomposition of Device (1071); Arcing (2583); Sparking (2595)

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

Event Date 03/06/2023

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 burnt capacitor component.It was confirmed that the capacitor failed, and troubleshooting identified that the failure resulted in thermal damage to the power board, as well as arcing to the machine frame.Sparks were reported to have occurred where the machine plugs into the outlet.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 machine has relatively low hours (exact hours unknown) and the power board was the original fresenius part on the machine.The biomed reported that there was no damage observed on any other components, or any other additional issues, associated with the burnt capacitor/ arcing.The biomed replaced the power board and power logic board, which resolved the issue.The unit was returned to service at the user facility without issue and without reoccurrence of the event.The power board is available for return to the manufacturer for physical evaluation.

Manufacturer Narrative

Additional information d9 and h3.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, a photograph of the sample was provided.The manufacturer was able to determine a causal relationship between the objective evidence provided by the biomedical technician and the reported event.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 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 burnt capacitor component.It was confirmed that the capacitor failed, and troubleshooting identified that the failure resulted in thermal damage to the power board, as well as arcing to the machine frame.Sparks were reported to have occurred where the machine plugs into the outlet.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 machine has relatively low hours (exact hours unknown) and the power board was the original fresenius part on the machine.The biomed reported that there was no damage observed on any other components, or any other additional issues, associated with the burnt capacitor/ arcing.The biomed replaced the power board and power logic board, which resolved the issue.The unit was returned to service at the user facility without issue and without reoccurrence of the event.The power board is available for return to the manufacturer for physical evaluation.

Event Description

A biomedical technician (biomed) at a user facility reported that a fresenius 2008t hemodialysis (hd) machine had a burnt capacitor component.It was confirmed that the capacitor failed, and troubleshooting identified that the failure resulted in thermal damage to the power board, as well as arcing to the machine frame.Sparks were reported to have occurred where the machine plugs into the outlet.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 machine has relatively low hours (exact hours unknown) and the power board was the original fresenius part on the machine.The biomed reported that there was no damage observed on any other components, or any other additional issues, associated with the burnt capacitor/ arcing.The biomed replaced the power board and power logic board, which resolved the issue.The unit was returned to service at the user facility without issue and without reoccurrence of the event.The power board is available for return to the manufacturer for physical evaluation.

Manufacturer Narrative

Additional information: h6 investigative findings.

• Brand Name: 2008T HD SYS. CDX W/BIBAG BLUE STAR
• 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: 16551664
• MDR Text Key: 311376391
• Report Number: 0002937457-2023-00387
• Device Sequence Number: 1
• Product Code: KDI
• UDI-Device Identifier: 00840861102099
• UDI-Public: 00840861102099
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K173972
• 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,Followup
• Report Date: 04/20/2023

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
• Device Operator: Health Professional
• Device Model Number: 191126
• Device Catalogue Number: 191126
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Initial Date Manufacturer Received: 03/06/2023
• Initial Date FDA Received: 03/16/2023
• Supplement Dates Manufacturer Received: 03/28/2023; 04/20/2023
• Supplement Dates FDA Received: 03/29/2023; 04/20/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/24/2019
• 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