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

Catalog Number 191126

Device Problems Smoking (1585); Sparking (2595)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 07/27/2023

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 user facility biomedical technician (biomed) reported to fresenius technical services that smoke and a spark were observed from the power supply of a 2008t machine.The reported issue occurred after the entire facility lost power during a thunderstorm.The machine shutdown during a patient¿s hemodialysis (hd) treatment.Power was restored to the facility but the machine could not be powered back on.An electrician was called to inspect the outlets to verify they are safe for machine usage.The clinic manager (cm) provided additional information during follow-up.The patient was immediately pulled from the machine when the reported event occurred.The patient could not be reinfused.The patient¿s estimated blood loss (ebl) was not provided.The patient did not experience a serious injury, adverse event, or require medical intervention.The patient¿s treatment ended for the day.Additional information was requested however a response was not received.No parts were returned to the manufacturer for physical evaluation.

Event Description

A user facility biomedical technician (biomed) reported to fresenius technical services that smoke and a spark were observed from the power supply of a 2008t machine.The reported issue occurred after the entire facility lost power during a thunderstorm.The machine shutdown during a patient¿s hemodialysis (hd) treatment.Power was restored to the facility but the machine could not be powered back on.An electrician was called to inspect the outlets to verify they are safe for machine usage.The clinic manager (cm) provided additional information during follow-up.The patient was immediately pulled from the machine when the reported event occurred.The patient could not be reinfused.The patient¿s estimated blood loss (ebl) was not provided.The patient did not experience a serious injury, adverse event, or require medical intervention.The patient¿s treatment ended for the day.A fresenius field service technician (fst) was called onsite to evaluate the machine.The repair details indicate that the machine has 2,593 hours.The reported power issue could be duplicated as the machine would not power on.The power supply was replaced to resolve this issue.The machine passed all functional testing.No parts were returned to the manufacturer for physical evaluation.

Manufacturer Narrative

Additional information, d9, h3 plant investigation: the power supply was returned to the manufacturer for physical evaluation.An initial inspection on the returned power supply found thermal damage to varistor (rv1) and soot on the power control board.Varistors are used to protect a circuit from high voltage surges.There is no other damage found on the power supply, power control board, and nearby components.The damaged varistor (rv1) was found to be shorted which can cause sparks and smoke on varistor (rv1).Varistor (rv1) was replaced on the power control board for testing.The power supply (reworked) was installed to a test machine for testing.The test machine powered up without failures.Rinse program completed without problems.Dialysis mode functioned properly without any failures.A self-test program completed without any failures.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 confirm the reported failure mode.

Event Description

A user facility biomedical technician (biomed) reported to fresenius technical services that smoke and a spark were observed from the power supply of a 2008t machine.The reported issue occurred after the entire facility lost power during a thunderstorm.The machine shutdown during a patient¿s hemodialysis (hd) treatment.Power was restored to the facility but the machine could not be powered back on.An electrician was called to inspect the outlets to verify they are safe for machine usage.The clinic manager (cm) provided additional information during follow-up.The patient was immediately pulled from the machine when the reported event occurred.The patient could not be reinfused.The patient¿s estimated blood loss (ebl) was not provided.The patient did not experience a serious injury, adverse event, or require medical intervention.The patient¿s treatment ended for the day.A fresenius field service technician (fst) was called onsite to evaluate the machine.The repair details indicate that the machine has 2,593 hours.The reported power issue could be duplicated as the machine would not power on.The power supply was replaced to resolve this issue.The machine passed all functional testing.No parts were returned to the manufacturer for physical evaluation.

• 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: 17493988
• MDR Text Key: 321239101
• Report Number: 0002937457-2023-01162
• 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
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup,Followup
• Report Date: 08/23/2023

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 Catalogue Number: 191126
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Initial Date Manufacturer Received: 07/27/2023
• Initial Date FDA Received: 08/09/2023
• Supplement Dates Manufacturer Received: 08/03/2023; 08/18/2023
• Supplement Dates FDA Received: 08/10/2023; 08/23/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/03/2021
• 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