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

Model Number 190766

Device Problems Thermal Decomposition of Device (1071); Melted (1385); Smoking (1585)

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

Event Date 10/10/2022

Event Type  malfunction  

Event Description

A user facility area technical operations manager (atom) reported that a fresenius 2008t hemodialysis (hd) machine began to smoke during the patient's hemodialysis (hd) treatment.The smoke triggered the facility smoke detectors and the local fire department was dispatched.The machine was pulled from the service floor and additional assistance was not required in extinguishing the smoke.There was no harm to the patient or any individuals present as a result of this malfunction.The patient's treatment was paused and their blood was returned.The patient was transferred to a new machine where treatment was successfully completed with new supplies.An evaluation of the machine was performed and it was determined that the source of the smoke was a burned and melted solenoid valve.The machine has approximately 27,382 hours and the solenoid valve 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 burned and melted solenoid valve.The biomed replaced the solenoid valve, which resolved the issue.The unit was returned to service at the user facility without issue and without reoccurrence of the event.The complaint sample is available to be returned to the manufacturer for physical evaluation.

Manufacturer Narrative

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

Event Description

A user facility area technical operations manager (atom) reported that a fresenius 2008t hemodialysis (hd) machine began to smoke during the patient's hemodialysis (hd) treatment.The smoke triggered the facility smoke detectors and the local fire department was dispatched.The machine was pulled from the service floor and additional assistance was not required in extinguishing the smoke.There was no harm to the patient or any individuals present as a result of this malfunction.The patient's treatment was paused and their blood was returned.The patient was transferred to a new machine where treatment was successfully completed with new supplies.An evaluation of the machine was performed and it was determined that the source of the smoke was a burned and melted solenoid valve.The machine has approximately 27,382 hours and the solenoid valve 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 burned and melted solenoid valve.The biomed replaced the solenoid valve, which resolved the issue.The unit was returned to service at the user facility without issue and without reoccurrence of the event.The complaint sample is available to be returned to the manufacturer for physical evaluation.

Manufacturer Narrative

Additional information: d9, 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 customer 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.

• 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: 15685543
• MDR Text Key: 302558385
• Report Number: 0002937457-2022-01808
• 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: Health Professional,User Facility,Company Representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 12/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2022
• 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: 11/22/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/27/2015
• 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
• Treatment: FRESENIUS BLOODLINES; FRESENIUS BLOODLINES; FRESENIUS DIALYZER; FRESENIUS DIALYZER
• Patient Age: 72 YR
• Patient Sex: Male
• Patient Weight: 77 KG