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 Fire (1245); Melted (1385)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/12/2020

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 fresenius field service technician (fst) was called onsite to evaluate a 2008t machine located at a hospital¿s hemodialysis (hd) unit.There was reported to be an outlet fire that melted the power plug of the machine.The reported event occurred during a patient¿s treatment on the machine.Additional information was obtained during follow up with the unit¿s biomedical technician (biomed).The biomed stated the machine powered off during the patient¿s treatment and a subsequent burning smell was noted by the registered nurse (rn) who was on duty.Hospital maintenance was called to the scene after the burning smell was noted.The rn unplugged the power cord and plugged the machine into a different outlet.Shortly afterwards, the rn noticed that the outlet the power supply was removed from was aflame.Hospital maintenance was at the scene at this point, and they blew out the flame.There was no smoke reported and the smoke detectors did not go off.Due to the situation, the patient was disconnected, and their treatment was ended.The patient was evacuated from the room.The biomed confirmed the patient did not experience any adverse effects due to the reported event, and no medical intervention was required.Maintenance removed the outlet and examined the wiring behind it to ensure there were no additional issues; none were found.The biomed stated that a fresenius fst came onsite to evaluate the machine.Prior to the start of the fst¿s machine inspection, the hospital¿s legal department decided they wanted an independent third party to perform the assessment.The fresenius fst was asked to postpone their evaluation of the machine until the third-party inspection was completed.According to the biomed, the outlet was the cause of the problem, not the machine or the power plug.The biomed stated there was no internal damage on the power plug; the damage was exclusively on the exterior of the plug.There were no other damaged components found, and though it was short-lived, the treatment was continued from a different outlet using the same power supply and plug.At the time of follow up, the third-party inspection was reportedly scheduled.The biomed stated that a copy of the results from the inspection would be shared once they are received.The biomed said the machine is up to date on its preventive maintenance (pm) checks, and confirmed the machine has no previous history of failing the electrical leakage test.The machine was out of service at the time of follow-up.

Manufacturer Narrative

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 power outlet (a non-fresenius product) was replaced.In addition, the machine's power cord was replaced.As a precaution, the entire power supply was also replaced.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 third-party inspection concluded that the hemodialysis (hd) machine was not a contributing factor to the reported event.The unit's biomedical technician confirmed the machine passed inspection and was returned to service.Due to the circumstances and the outcome of the third-party inspection, the reported complaint event could not be 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: 9784464
• MDR Text Key: 181908639
• Report Number: 2937457-2020-00427
• 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: 03/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2020
• 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
• Date Manufacturer Received: 03/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1