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 Patient Involvement (2645)

Event Date 06/12/2020

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 there was an issue with a replacement pump head for a fresenius 2008t hemodialysis (hd) machine.The pump head was reportedly new out of the box and did not fit on the housing properly.The biomed stated the magnetic coupling on the deaeration motor was flush with the metal triangle housing, and it was preventing the motor from spinning freely.This created friction, which heated up the parts, and led to burn damage on the motor windings and melting on the wiring insulation.The biomed also reported a burning smell coming from the insulation.There were no signs of smoke, sparks, or flames.The biomed confirmed the parts were all original fresenius manufactured parts.It was unknown how many hours were on the machine at the time of the event.No damage was identified on any other components.The machine was plugged into a hospital grade ground-fault circuit interrupter (gfci) outlet, and there was no previous history of the machine failing the electrical leakage test.The biomed replaced the entire pump drive assembly to resolve the reported issue.Following the repair, the machine was returned to service and there have been no further issues.The biomed stated the old pump drive assembly was still at the facility and they planned to contact technical service to set up a return.There was no patient involvement associated with the reported event.

Manufacturer Narrative

Additional information: 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.

• 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
• MDR Report Key: 10228500
• MDR Text Key: 197536716
• Report Number: 2937457-2020-01210
• Device Sequence Number: 1
• Product Code: KDI
• UDI-Device Identifier: 00840861100897
• UDI-Public: 00840861100897
• Combination Product (y/n): N
• PMA/PMN Number: K093902
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 07/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/03/2020
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 190713
• Device Catalogue Number: 190713
• Was Device Available for Evaluation?: Yes
• Device Age: MO
• Date Manufacturer Received: 07/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1