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 Patient Involvement (2645)

Event Date 11/06/2019

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

During the preventive maintenance (pm) check of a 2008t hemodialysis (hd) machine, a fresenius field service technician (fst) identified burn damage on the main power supply cable.It was reported that the cable appeared charred and slightly melted.It was also reported that a burning scent was noticeable.There were no signs of smoke, sparks, or flames.No other damaged components or parts were found.The fst replaced the power supply cable to resolve the reported issue.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.Upon follow up with the biomedical technician from the user facility, it was confirmed the machine was returned to service and has not experienced any further issues.The damaged cable was reportedly discarded and photo evidence of said damage could not be provided.There was no patient involvement associated with the reported event.

Manufacturer Narrative

Additional information: 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).To resolve the reported issue, the fst replaced the main power supply cable.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.During the preventive maintenance (pm) check, the fresenius fst identified burn damage on the power supply cable.Therefore, the complaint event was 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
• MDR Report Key: 9528034
• MDR Text Key: 172964460
• Report Number: 2937457-2019-03659
• 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: 01/21/2020

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?: Yes
• Device Age: MO
• Initial Date Manufacturer Received: 12/11/2019
• Initial Date FDA Received: 12/27/2019
• Supplement Dates Manufacturer Received: 01/17/2020
• Supplement Dates FDA Received: 01/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1