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); Fire (1245); Smoking (1585)

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

Event Date 03/16/2023

Event Type  malfunction  

Event Description

A user facility biomedical technician (bmt) reported that during a patient's hemodialysis (hd) treatment a fresenius 2008t hemodialysis (hd) machine produced a fire (heavy smoke seen from machine).The machine did not alarm and had to be turned off to keep from getting worse.The patient moved to new machine and treatment resumed with no issue.The bmt replaced the actuator, functional, actuator cable and p41 (monitor usb) due to physical damage apparent to the eye (charring).The machine started working again but had negative pressure test failures and air detector alarms.The bmt swapped the sensor board and the level detector module and was able to get the air detector alarm cleared and successfully calibrated after several tries.The bmt ran the self tests again and the machine passed air detector, but failed "get neg tmp" portion.The bmt was asked to calibrate dialysate pressure and venous pressure and re-run the self tests.After powering back on from the calibration, the air detector alarm came back and would no longer clear or calibrate.The bmt reinstalled the original actuator board and the machine passed all tests except temperature with the burned actuator board in the machine.The bmt stated he ordered a new actuator board.Upon follow-up, the bmt stated the actuator board was replaced, which resolved the issue.The machine was placed back in service without issue.The bmt confirmed there was no patient injury, adverse events, or medical intervention required as a result of the reported event.The patient was restarted on a different machine and treatment completed successfully with new supplies.The bmt confirmed the machine is plugged into a hospital grade ground-fault circuit interrupter (gfci) outlet and does not have a history of failing an electrical leakage test.The bmt confirmed that a patient was connected to the machine at the time of the incident and there was no harm to the patient because of this malfunction.The bmt confirmed that the components were available for return to the manufacturer for physical evaluation via return goods authorization (rga).

Manufacturer Narrative

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

Manufacturer Narrative

Correction: h6 medical device problem code.

Event Description

A user facility biomedical technician (bmt) reported that during a patient's hemodialysis (hd) treatment a fresenius 2008t hemodialysis (hd) machine produced a heavy smoke seen from machine.The machine did not alarm and had to be turned off to keep from getting worse.The bmt confirmed there was no fire and that only heavy smoke was noted as a result of the shorted actuator board.The fire department was not dispatched and a fire extinguisher was not used or needed.The machine was turned off and the heavy smoke subsided on it's own.The patient moved to new machine and treatment resumed with no issue.The bmt replaced the actuator, functional, actuator cable and p41 (monitor usb) due to physical damage apparent to the eye (charring).The machine started working again but had negative pressure test failures and air detector alarms.The bmt the swapped the sensor board and the level detector module and was able to get the air detector alarm cleared and successfully calibrated after several tries.The bmt ran the self tests again and the machine passed air detector, but failed "get neg tmp" portion.The bmt was asked to calibrate dialysate pressure and venous pressure and re-run the self tests.After powering back on from the calibration, the air detector alarm came back and would no longer clear or calibrate.The bmt reinstalled the original actuator board and the machine passed all tests except temperature with the burned actuator board in the machine.The bmt stated he ordered a new actuator board.Upon follow-up, the bmt stated the actuator board was replaced, which resolved the issue.The machine was placed back in service without issue.The bmt confirmed there was no patient injury, adverse events, or medical intervention required as a result of the reported event.The patient was restarted on a different machine and treatment completed successfully with new supplies.The bmt confirmed the machine is plugged into a hospital grade ground-fault circuit interrupter (gfci) outlet and does not have a history of failing an electrical leakage test.The bmt confirmed that a patient was connected to the machine at the time of the incident and there was no harm to the patient because of this malfunction.The bmt confirmed that the components were available for return to the manufacturer for physical evaluation via return goods authorization (rga).

Manufacturer Narrative

Additional information: d9, h3 plant investigation: no parts were returned to the manufacturer for physical evaluation.Complaint investigation found objective evidence indicating a product problem, thus the complaint is confirmed.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 investigation into the cause of the reported problem was able to be confirmed.

Event Description

A user facility biomedical technician (bmt) reported that during a patient's hemodialysis (hd) treatment a fresenius 2008t hemodialysis (hd) machine produced a heavy smoke seen from machine.The machine did not alarm and had to be turned off to keep from getting worse.The bmt confirmed there was no fire and that only heavy smoke was noted as a result of the shorted actuator board.The fire department was not dispatched and a fire extinguisher was not used or needed.The machine was turned off and the heavy smoke subsided on it's own.The patient moved to new machine and treatment resumed with no issue.The bmt replaced the actuator, functional, actuator cable and p41 (monitor usb) due to physical damage apparent to the eye (charring).The machine started working again but had negative pressure test failures and air detector alarms.The bmt the swapped the sensor board and the level detector module and was able to get the air detector alarm cleared and successfully calibrated after several tries.The bmt ran the self tests again and the machine passed air detector, but failed "get neg tmp" portion.The bmt was asked to calibrate dialysate pressure and venous pressure and re-run the self tests.After powering back on from the calibration, the air detector alarm came back and would no longer clear or calibrate.The bmt reinstalled the original actuator board and the machine passed all tests except temperature with the burned actuator board in the machine.The bmt stated he ordered a new actuator board.Upon follow-up, the bmt stated the actuator board was replaced, which resolved the issue.The machine was placed back in service without issue.The bmt confirmed there was no patient injury, adverse events, or medical intervention required as a result of the reported event.The patient was restarted on a different machine and treatment completed successfully with new supplies.The bmt confirmed the machine is plugged into a hospital grade ground-fault circuit interrupter (gfci) outlet and does not have a history of failing an electrical leakage test.The bmt confirmed that a patient was connected to the machine at the time of the incident and there was no harm to the patient because of this malfunction.The bmt confirmed that the components were available for return to the manufacturer for physical evaluation via return goods authorization (rga).

• 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: 16584453
• MDR Text Key: 311695945
• Report Number: 0002937457-2023-00419
• 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: 05/01/2023

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: Other
• 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: 03/16/2023
• Initial Date FDA Received: 03/21/2023
• Supplement Dates Manufacturer Received: 04/19/2023; 05/01/2023
• Supplement Dates FDA Received: 04/19/2023; 05/01/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/25/2018
• 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 BLOODLINES.; FRESENIUS DIALYZER.; FRESENIUS DIALYZER.; FRESENIUS DIALYZER.