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 01/25/2023

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 service (ts) that a 2008t hemodialysis (hd) machine would not get up to conductivity and a burning smell was coming from the machine.The biomed inspected the machine and found thermal damage at valve 105.The biomed said the valve and its wiring harness were completely melted out, and the tubing around the valve was burnt and melted.There were no reports of any smoke, sparks, or flames.The biomed replaced the valve and affected tubing.Afterwards, while putting the machine through a rinse cycle, the biomed noticed fluid leaking from the bibag door.The biomed replaced the interface board for the bibag module, but the leaking from the bibag door continued.At one point, the biomed reported encountering a momentary flow inlet error.They tried replacing valve 100, valve 103, and the entire bibag assembly.This still did not resolve the issue.Finally, the biomed replaced the bibag door and the leaking stopped.The machine passed all testing and was subsequently returned to service.The biomed stated the machine had 29,017 hours on it.The machine was plugged into a hospital grade ground-fault circuit interrupter (gfci) outlet and had no previous history of failing the electrical leakage test.No parts were available to be returned for manufacturer evaluation.The biomed said the damaged valve and tubing were discarded.However, photos of the parts were provided for review.There was no patient involvement associated with the reported event.

Event Description

A user facility biomedical technician (biomed) reported to fresenius technical service (ts) that a 2008t hemodialysis (hd) machine would not get up to conductivity and a burning smell was coming from the machine.The biomed inspected the machine and found thermal damage at valve 105.The biomed said the valve and its wiring harness were completely melted out, and the tubing around the valve was burnt and melted.There were no reports of any smoke, sparks, or flames.The biomed replaced the valve and affected tubing.Afterwards, while putting the machine through a rinse cycle, the biomed noticed fluid leaking from the bibag door.The biomed replaced the interface board for the bibag module, but the leaking from the bibag door continued.At one point, the biomed reported encountering a momentary flow inlet error.They tried replacing valve 100, valve 103, and the entire bibag assembly.This still did not resolve the issue.Finally, the biomed replaced the bibag door and the leaking stopped.The machine passed all testing and was subsequently returned to service.The biomed stated the machine had 29,017 hours on it.The machine was plugged into a hospital grade ground-fault circuit interrupter (gfci) outlet and had no previous history of failing the electrical leakage test.No parts were available to be returned for manufacturer evaluation.The biomed said the damaged valve and tubing were discarded.However, photos of the parts were provided for review.There was no patient involvement associated with the reported event.

Manufacturer Narrative

Plant investigation: no parts were returned to the manufacturer for physical evaluation and an on-site evaluation was not performed by a fresenius field service technician (fst).However, photographs of the affected parts were provided for review.The manufacturer was able to determine a causal relationship between the objective evidence provided by the customer and the reported event.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 reported event has been confirmed.

• 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: 16368611
• MDR Text Key: 309460589
• Report Number: 0002937457-2023-00208
• 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
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 03/09/2023

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?: No
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Initial Date Manufacturer Received: 01/25/2023
• Initial Date FDA Received: 02/13/2023
• Supplement Dates Manufacturer Received: 02/28/2023
• Supplement Dates FDA Received: 03/09/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/11/2015
• 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