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

Catalog Number 191130

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

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

Event Date 12/22/2023

Event Type  malfunction  

Event Description

A user facility biomedical technician reported to fresenius that a 2008t hemodialysis (hd) machine generated sparks and would not power on.There was no patient involvement associated with the reported event.A fresenius field service technician (fst) was subsequently dispatched to the facility to evaluate the machine.The fst stated there was a power surge at the facility.During their own evaluation, the fst did not notice any sparking coming from the system.The fst said the machine tripped the breaker when they tried powering it on.They heard the ground fault interrupter ¿popping¿ when doing this.Upon further inspection, the fst found a burnt/charred capacitor on the lp955 board.The fst could not confirm that it was an original fresenius part as this particular customer often buys refurbished parts from a third party.There was no burning smell noted, and no other parts were found damaged.The fst fixed the machine by replacing the entire power supply.The machine had 1,983 hours on it at the time of the repair.The machine was plugged into a hospital grade ground-fault circuit interrupter (gfci) outlet, and to the fst¿s knowledge, it had no previous history of failing the electrical leakage test.The fst confirmed the machine was returned to service upon completion of the repair.No photos of the burnt component were available for review.The power supply was reportedly sent back for manufacturer evaluation.

Manufacturer Narrative

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

Manufacturer Narrative

Additional information: h3 plant investigation: although a sample was reported to be available for manufacturer evaluation, to date no parts have been received.However, an on-site evaluation was performed by a fresenius field service technician (fst).To resolve the reported issue, the fst replaced the entire power supply.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.During the machine inspection, the fresenius fst identified evidence of thermal damage.Therefore, the complaint event was confirmed.

Event Description

A user facility biomedical technician reported to fresenius that a 2008t hemodialysis (hd) machine generated sparks and would not power on.There was no patient involvement associated with the reported event.A fresenius field service technician (fst) was subsequently dispatched to the facility to evaluate the machine.The fst stated there was a power surge at the facility.During their own evaluation, the fst did not notice any sparking coming from the system.The fst said the machine tripped the breaker when they tried powering it on.They heard the ground fault interrupter ¿popping¿ when doing this.Upon further inspection, the fst found a burnt/charred capacitor on the lp955 board.The fst could not confirm that it was an original fresenius part as this particular customer often buys refurbished parts from a third party.There was no burning smell noted, and no other parts were found damaged.The fst fixed the machine by replacing the entire power supply.The machine had 1,983 hours on it at the time of the repair.The machine was plugged into a hospital grade ground-fault circuit interrupter (gfci) outlet, and to the fst¿s knowledge, it had no previous history of failing the electrical leakage test.The fst confirmed the machine was returned to service upon completion of the repair.No photos of the burnt component were available for review.The power supply was reportedly sent back for manufacturer evaluation.

• Brand Name: 2008T HD SYS. W/O 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: 18508810
• MDR Text Key: 332867170
• Report Number: 0002937457-2024-00076
• Device Sequence Number: 1
• Product Code: KDI
• UDI-Device Identifier: 00840861102112
• UDI-Public: 00840861102112
• 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
• Report Date: 01/30/2024

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 Catalogue Number: 191130
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Initial Date Manufacturer Received: 12/23/2023
• Initial Date FDA Received: 01/12/2024
• Supplement Dates Manufacturer Received: 01/19/2024
• Supplement Dates FDA Received: 01/30/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/04/2020
• 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