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); Smoking (1585)

Patient Problem No Patient Involvement (2645)

Event Date 01/14/2020

Event Type  malfunction  

Manufacturer Narrative

The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity. .

Event Description

It was reported that there was smoke coming from the actuator board of a hemodialysis (hd) machine.There were no diagnostic messages or audible alarms reported.At the time of the report, it could not be confirmed what component of the board smoked.A new actuator board was installed and the machine still had a burning smell.Upon follow-up with the biomedical technician (biomed), it was confirmed that a valve on the bibag assembly was burned, discolored, and melted.The biomed stated that the issue was found during inspection.The bibag assembly/valve is the original fresenius part.The machine has approximately 19,000 to 20,000 hours.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 issue.The biomed stated that machine did not have any past problems with failing the electrical leakage test or any other damaged component associated with the damaged valve.The biomed stated that the valve was replaced and the machine is back in service without further issue.The part is not available to be returned to the manufacturer for evaluation because it was discarded.

Manufacturer Narrative

Plant investigation: no parts were returned to the manufacturer for physical evaluation.Additionally, no on-site evaluation was performed by a fresenius regional equipment specialist (res).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 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
• MDR Report Key: 9617230
• MDR Text Key: 175902997
• Report Number: 2937457-2020-00148
• Device Sequence Number: 1
• Product Code: KDI
• UDI-Device Identifier: 00840861100910
• UDI-Public: 00840861100910
• Combination Product (y/n): N
• PMA/PMN Number: K121341
• 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: 01/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 190766
• Device Catalogue Number: 190766
• Was Device Available for Evaluation?: No
• Device Age: MO
• Initial Date Manufacturer Received: 01/14/2020
• Initial Date FDA Received: 01/22/2020
• Supplement Dates Manufacturer Received: 01/23/2020
• Supplement Dates FDA Received: 01/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1