MAUDE Adverse Event Report: CONCORD MANUFACTURING 2008T HEMODIALYSIS SYS., WITH CDX; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Model Number 190713

Device Problems Thermal Decomposition of Device (1071); Fire (1245); Smoking (1585); Sparking (2595)

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

Event Date 02/03/2023

Event Type  malfunction  

Event Description

A user facility biomedical technician (biomed) reported to fresenius technical services that a 2008t machine caught fire.The biomed stated that the event occurred shortly after the machine received a standard software upgrade.The biomed confirmed the reported event during follow-up and provided additional information.The biomed stated that the machine had been removed from service for machine repair.The deaeration motor, pump, and gearhead had just been replaced.The biomed re-plugged in the machine and powered it on to enter service mode and calibrate the deaeration motor when an electrical smell was observed.The biomed then observed ¿a zap.¿ the biomed opened the card cage and observed smoke.The biomed noted that this issue occurred in a matter of seconds.The biomed unplugged the machine and stated the issue was resolved when the machine was no longer powered.A fire extinguisher was not required.Smoke detectors inside the facility were not triggered.There was no patient involvement or personal harm as a result of this issue.The biomed stated that the machine has 39,504 machine hours.The machine does not have a history of failing the electrical leakage test.The biomed noted that the function and actuator boards within the case sustained thermal damage from this event.The biomed stated that all boards inside the cage were replaced to eliminate any further damage from occurring.The biomed stated that the machine remains out of service as it will not complete calibrations.The biomed confirmed that any samples were discarded and are unavailable 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 biomedical technician (biomed) reported to fresenius technical services that a 2008t machine caught fire.The biomed stated that the event occurred shortly after the machine received a standard software upgrade.The biomed confirmed the reported event during follow-up and provided additional information.The biomed stated that the machine had been removed from service for machine repair.The deaeration motor, pump, and gearhead had just been replaced.The biomed re-plugged in the machine and powered it on to enter service mode and calibrate the deaeration motor when an electrical smell was observed.The biomed then observed ¿a zap.¿ the biomed opened the card cage and observed smoke.The biomed noted that this issue occurred in a matter of seconds.The biomed unplugged the machine and stated the issue was resolved when the machine was no longer powered.A fire extinguisher was not required.Smoke detectors inside the facility were not triggered.There was no patient involvement or personal harm as a result of this issue.The biomed stated that the machine has 39,504 machine hours.The machine does not have a history of failing the electrical leakage test.The biomed noted that the function and actuator boards within the case sustained thermal damage from this event.The biomed stated that all boards inside the cage were replaced to eliminate any further damage from occurring.The biomed stated that the machine remains out of service as it will not complete calibrations.The biomed confirmed that any samples were discarded and are unavailable to be returned to the manufacturer for physical evaluation.

Manufacturer Narrative

Correction h6 (device component code).

Event Description

A user facility biomedical technician (biomed) reported to fresenius technical services that a 2008t machine caught fire.The biomed stated that the event occurred shortly after the machine received a standard software upgrade.The biomed confirmed the reported event during follow-up and provided additional information.The biomed stated that the machine had been removed from service for machine repair.The deaeration motor, pump, and gearhead had just been replaced.The biomed re-plugged in the machine and powered it on to enter service mode and calibrate the deaeration motor when an electrical smell was observed.The biomed then observed ¿a zap.¿ the biomed opened the card cage and observed smoke.The biomed noted that this issue occurred in a matter of seconds.The biomed unplugged the machine and stated the issue was resolved when the machine was no longer powered.A fire extinguisher was not required.Smoke detectors inside the facility were not triggered.There was no patient involvement or personal harm as a result of this issue.The biomed stated that the machine has 39,504 machine hours.The machine does not have a history of failing the electrical leakage test.The biomed noted that the function and actuator boards within the case sustained thermal damage from this event.The biomed stated that all boards inside the cage were replaced to eliminate any further damage from occurring.The biomed stated that the machine remains out of service as it will not complete calibrations.The biomed confirmed that any samples were discarded and are unavailable to be returned to the manufacturer for physical evaluation.

Manufacturer Narrative

Correction: d8 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).However photographs of the reported issue were provided.From the photographs the manufacturer was able to confirm the reported issue.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.

• Brand Name: 2008T HEMODIALYSIS SYS., WITH CDX
• 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: 16410088
• MDR Text Key: 309891547
• Report Number: 0002937457-2023-00258
• Device Sequence Number: 1
• Product Code: KDI
• UDI-Device Identifier: 00840861100897
• UDI-Public: 00840861100897
• 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,Company Representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup,Followup
• Report Date: 03/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 190713
• Device Catalogue Number: 190713
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Date Manufacturer Received: 03/21/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/22/2013
• 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