MAUDE Adverse Event Report: CONCORD MANUFACTURING 2008T HEMODIALYSIS SYSTEM W/BIBAG; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Model Number 190766

Device Problems Thermal Decomposition of Device (1071); Melted (1385)

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

Event Date 11/15/2022

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 valve 104 of a fresenius 2008t hemodialysis (hd) machine burned and melted during heat disinfection mode.There were no audible alarms however the display went blank.The biomed reported the machine was originally pulled from service for calibration of the conductivity cells.The biomed noted the machine alarmed with a "no comm.To 90xl message" when the mesa serial cable and null modem adapter were properly connected.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.The machine has approximately 22,000 hours and the valve 104 was the original fresenius part on the machine.The biomed replaced valve 104 and noted that the functional board also required replacement as a result of the reported issue with valve 104.The unit was returned to service at the user facility without issue and without reoccurrence of the event.The complaint sample is available to be returned to the manufacturer for physical evaluation.

Event Description

A biomedical technician (biomed) at a user facility reported that valve 104 of a fresenius 2008t hemodialysis (hd) machine burned and melted during heat disinfection mode.There were no audible alarms however the display went blank.The biomed reported the machine was originally pulled from service for calibration of the conductivity cells.The biomed noted the machine alarmed with a "no comm.To 90xl message" when the mesa serial cable and null modem adapter were properly connected.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.The machine has approximately 22,000 hours and the valve 104 was the original fresenius part on the machine.The biomed replaced valve 104 and noted that the functional board also required replacement as a result of the reported issue with valve 104.The unit was returned to service at the user facility without issue and without reoccurrence of the event.The complaint sample is available to be returned to the manufacturer for physical evaluation.

Manufacturer Narrative

The solenoid valve was returned to the manufacturer for physical evaluation.Thermal damage and corrosion was noted on the sample.The housing is torn from the thermal event.There are signs of fluid leaks on the side of the valve.The valve is out of specification between the terminals which must read between 40 and 100 ohms.The solenoid valve v104 was installed (as-received condition) onto test machine for testing.No problems during the initial power up.A heat disinfection program was able to be completed without any further damaging the valve and burning smell.However, the machine encountered the ¿v104/108 stuck closed¿ alarm during power up (after heat disinfection) and during dialysis.Internal inspection found a broken o-ring and signs of fluid leak and corrosion in the valve.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.

Manufacturer Narrative

Correction: h10 (plant investigation) plant investigation: the solenoid valve was returned to the manufacturer for physical evaluation.Thermal damage and corrosion was noted on the sample.The housing is torn from the thermal event.There are signs of fluid leaks on the side of the valve.The valve is out of specification between the terminals which must read between 40 and 100 ohms(¿).The solenoid valve v104 was installed (as-received condition) onto test machine for testing.No problems during the initial power up.A heat disinfection program was able to be completed without any further damaging the valve and burning smell.However, the machine encountered the ¿v104/108 stuck closed¿ alarm during power up (after heat disinfection) and during dialysis.Internal inspection found a broken o-ring and signs of fluid leak and corrosion in the valve.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 was able to confirm the reported issue.

Event Description

A biomedical technician (biomed) at a user facility reported that valve 104 of a fresenius 2008t hemodialysis (hd) machine burned and melted during heat disinfection mode.There were no audible alarms however the display went blank.The biomed reported the machine was originally pulled from service for calibration of the conductivity cells.The biomed noted the machine alarmed with a "no comm.To 90xl message" when the mesa serial cable and null modem adapter were properly connected.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.The machine has approximately 22,000 hours and the valve 104 was the original fresenius part on the machine.The biomed replaced valve 104 and noted that the functional board also required replacement as a result of the reported issue with valve 104.The unit was returned to service at the user facility without issue and without reoccurrence of the event.The complaint sample is available to be returned to the manufacturer for physical evaluation.

• Brand Name: 2008T HEMODIALYSIS SYSTEM W/BIBAG
• 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: 15853738
• MDR Text Key: 304206436
• Report Number: 0002937457-2022-02047
• Device Sequence Number: 1
• Product Code: KDI
• UDI-Device Identifier: 00840861100910
• UDI-Public: 00840861100910
• 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: 01/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/23/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 190766
• Device Catalogue Number: 190766
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Date Manufacturer Received: 01/03/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/13/2016
• 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