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

Model Number 190766

Device Problem Thermal Decomposition of Device (1071)

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

Event Date 08/30/2022

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 user facility reported to fresenius technical service (ts) that a fresenius 2008t hemodialysis (hd) machine was having issues during chemical disinfection.The chemical disinfection could not be completed due to a flow error alarm that was occurring.A fresenius field service technician (fst) was called on site to repair the 2008t machine.The hd machine was placed into a full rinse, and it began alarming intermittently with a flow error alarm.The fst pulled the hydraulic cage out for inspection and found that valve 108 was damaged by leaking fluid (concentrate solution), and the connection cable was corroded.The fst replaced valve 108 and the corroded cable, but the flow error alarm continued to occur.The fst then noticed that valve 30 was leaking from the inlet tubing, which may have been responsible for the intermittent flow error.However, valve 30 was replaced and the flow error alarm continued.Upon further inspection, the fst found that the flow pressure was measuring very low, at 29.97 psi.Per the fst, the flow pressure should be between 35 and 36 psi.The fst readjusted the flow pressure to 35.48 psi and placed the machine back into rinse.The full rinse cycle was then completed without any issue.Further testing was performed and the machine was placed back into a chemical disinfection, and again the machine began alarming with a flow error alarm.The fst found that valve 39 was the cause of the alarm.The fst stated there was a split in the center of the valve.The fst replaced the damaged valve and re-rinsed the machine.Following this repair, the machine went through testing and passed all treatment tests three times.After functional testing was completed, the machine was returned to service.There was no patient involvement associated with the reported event.It is unknown if any parts were available for evaluation.However, photos were provided by the fst for review.Upon review of the photos, thermal damage was identified on a machine component.

Manufacturer Narrative

Correction: d9 additional information: h3 plant investigation: no parts were returned to the manufacturer for physical evaluation.However, an on-site evaluation was performed by a fresenius field service technician (fst).In addition, photos of the damaged component were provided for review.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.The fst identified thermal damage on a machine component, as depicted in the provided photos.Therefore, the complaint event was confirmed.

Event Description

A user facility reported to fresenius technical service (ts) that a fresenius 2008t hemodialysis (hd) machine was having issues during chemical disinfection.The chemical disinfection could not be completed due to a flow error alarm that was occurring.A fresenius field service technician (fst) was called onsite to repair the 2008t machine.The hd machine was placed into a full rinse, and it began alarming intermittently with a flow error alarm.The fst pulled the hydraulic cage out for inspection and found that valve 108 was damaged by leaking fluid (concentrate solution), and the connection cable was corroded.The fst replaced valve 108 and the corroded cable, but the flow error alarm continued to occur.The fst then noticed that valve 30 was leaking from the inlet tubing, which may have been responsible for the intermittent flow error.However, valve 30 was replaced and the flow error alarm continued.Upon further inspection, the fst found that the flow pressure was measuring very low, at 29.97 psi.Per the fst, the flow pressure should be between 35 and 36 psi.The fst readjusted the flow pressure to 35.48 psi and placed the machine back into rinse.The full rinse cycle was then completed without any issue.Further testing was performed and the machine was placed back into a chemical disinfection, and again the machine began alarming with a flow error alarm.The fst found that valve 39 was the cause of the alarm.The fst stated there was a split in the center of the valve.The fst replaced the damaged valve and re-rinsed the machine.Following this repair, the machine went through testing and passed all treatment tests three times.After functional testing was completed, the machine was returned to service.There was no patient involvement associated with the reported event.It is unknown if any parts were available for evaluation.However, photos were provided by the fst for review.Upon review of the photos, thermal damage was identified on a machine component.

• 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: 16065020
• MDR Text Key: 306315011
• Report Number: 0002937457-2022-02220
• 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
• Report Date: 01/18/2023

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: 190766
• Device Catalogue Number: 190766
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Initial Date Manufacturer Received: 09/01/2022
• Initial Date FDA Received: 12/28/2022
• Supplement Dates Manufacturer Received: 01/12/2023
• Supplement Dates FDA Received: 01/18/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/05/2016
• 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