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 Problem Thermal Decomposition of Device (1071)

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

Event Date 12/16/2021

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 biomedical technician (biomed) at a user facility reported that a fresenius 2008t hemodialysis (hd) machine had a burned actuator-test board.Biomed stated that a 2008t machine was displaying a flow inlet error in rinse.Biomed also stated that upon troubleshooting the machine issue, he found that the actuator-test board was burned.Biomed did not observe any burning smell, smoke, spark, flame, arcing, or any other visible heat or electrical damage related to the burned damage found on the actuator-test board.Biomed stated that the machine has approximately 500-800 hours and that the actuator-test board is the original fresenius part on the machine.Biomed confirmed the machine has not had any past problems with failing the electrical leakage test and is always plugged into a hospital grade ground-fault circuit interrupter (gfci) outlet.Biomed stated that the actuator-test board will be replaced this week.Therefore, the machine is not back in service.Additionally, biomed confirmed that there was also burn damage observed on the ribbon cable connected to the bibag assembly.Biomed confirmed that a patient was not connected to the machine at the time of the incident and there was no harm to any patients or individuals because of this malfunction.Biomed confirmed that the actuator-test board is available for return to the manufacturer for physical evaluation.

Manufacturer Narrative

Additional information: d9, h3 plant investigation: although it was stated that the complaint device was available to be returned, to date no parts were returned to the manufacturer for physical evaluation.Additionally, no on-site evaluation was performed by a fresenius field service technician (fst).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 not able to be confirmed.A definitive conclusion regarding the complaint incident cannot be reached without a physical examination of the complaint device.

Event Description

A biomedical technician (biomed) at a user facility reported that a fresenius 2008t hemodialysis (hd) machine had a burned actuator-test board.Biomed stated that a 2008t machine was displaying a flow inlet error in rinse.Biomed also stated that upon troubleshooting the machine issue, he found that the actuator-test board was burned.Biomed did not observe any burning smell, smoke, spark, flame, arcing, or any other visible heat or electrical damage related to the burned damage found on the actuator-test board.Biomed stated that the machine has approximately 500-800 hours and that the actuator-test board is the original fresenius part on the machine.Biomed confirmed the machine has not had any past problems with failing the electrical leakage test and is always plugged into a hospital grade ground-fault circuit interrupter (gfci) outlet.Biomed stated that the actuator-test board will be replaced this week.Therefore, the machine is not back in service.Additionally, biomed confirmed that there was also burn damage observed on the ribbon cable connected to the bibag assembly.Biomed confirmed that a patient was not connected to the machine at the time of the incident and there was no harm to any patients or individuals because of this malfunction.Biomed confirmed that the actuator-test board is available for return 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: jason busch ; 920 winter st; waltham, MA 02451 ; 9043166958
• MDR Report Key: 13055743
• MDR Text Key: 282588237
• Report Number: 2937457-2021-02488
• 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
• Report Date: 01/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 191126
• Device Catalogue Number: 191126
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Date Manufacturer Received: 01/07/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/16/2020
• 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