MAUDE Adverse Event Report: CONCORD MANUFACTURING 2008T HEMODIALYSIS SYS., WITH CDX; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Model Number 190713

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

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

Event Date 10/07/2022

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 regional technical operations manager (rtom) reported that thermal damage was found on a fresenius 2008t hemodialysis (hd) machine.The rtom said a burning smell was noted during setup for a patient¿s treatment.There was no patient involvement associated with the event.The machine was removed from the floor for inspection, and the smell was traced to valve #25.There was visible overheating and thermal damage around the valve (photos were provided for review).It was confirmed there were no signs of any smoke, sparks, or flames.A fresenius field service technician (fst) was dispatched to the site for further evaluation.The thermal damage was confirmed.The internal o-rings in the valve water compartment were worn.The solenoid case on valve #25 was melted, there was a split in the middle, and signs of fluid were noted inside.The wire harness also had heat damage on the leads where the connection is made to the valve.No damage was identified on any other components.The resistance of valve solenoid #25 was reportedly 4.1 ohms.To resolve the reported issue, the fst replaced the valve and the wire harness.The machine had 31,285 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.The rtom confirmed the machine was returned to service.The damaged valve was reportedly returned for manufacturer evaluation.

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) and photos were provided for review.The fst confirmed finding thermal damage on the machine.To resolve the reported issue, the fst replaced the damaged valve and the wire harness.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 determine a causal relationship between the objective evidence provided by the customer and the reported event.The reported event has been confirmed.

Event Description

A regional technical operations manager (rtom) reported that thermal damage was found on a fresenius 2008t hemodialysis (hd) machine.The rtom said a burning smell was noted during setup for a patient¿s treatment.There was no patient involvement associated with the event.The machine was removed from the floor for inspection, and the smell was traced to valve #25.There was visible overheating and thermal damage around the valve (photos were provided for review).It was confirmed there were no signs of any smoke, sparks, or flames.A fresenius field service technician (fst) was dispatched to the site for further evaluation.The thermal damage was confirmed.The internal o-rings in the valve water compartment were worn.The solenoid case on valve #25 was melted, there was a split in the middle, and signs of fluid were noted inside.The wire harness also had heat damage on the leads where the connection is made to the valve.No damage was identified on any other components.The resistance of valve solenoid #25 was reportedly 4.1 ohms.To resolve the reported issue, the fst replaced the valve and the wire harness.The machine had 31,285 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.The rtom confirmed the machine was returned to service.The damaged valve was reportedly returned for manufacturer evaluation.

• Brand Name: 2008T HEMODIALYSIS SYS., WITH CDX
• 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: 15695298
• MDR Text Key: 302671089
• Report Number: 0002937457-2022-01826
• Device Sequence Number: 1
• Product Code: KDI
• UDI-Device Identifier: 00840861100897
• UDI-Public: 00840861100897
• 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: 11/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/29/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 190713
• Device Catalogue Number: 190713
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Date Manufacturer Received: 11/10/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/03/2014
• 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