MAUDE Adverse Event Report: CONCORD MANUFACTURING 2008T HEMODIALYSIS SYSTEM W/BIBAG; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Catalog Number 190766

Device Problems Thermal Decomposition of Device (1071); Melted (1385); Arcing (2583)

Patient Problem No Patient Involvement (2645)

Event Date 02/16/2018

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 biomedical technician (biomed) at a user facility reported that a fresenius 2008t hemodialysis (hd) machine had a burned and melted power plug.The burned power plug was noticed during machine repair.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 malfunction.The biomed confirmed that the plug was the original fresenius part on the machine.The biomed reported that there was no burning smell, smoke, spark, or flame observed.The biomed reported that the machine has not had any past problems with failing the electrical leakage test and that there was no damage observed on any other components.The machine has approximately 4,000 hours and is plugged into a hospital grade ground-fault circuit interrupter (gfci) outlet.The biomed replaced the plug, which resolved the issue.The biomed reported that the machine is back in service.The power plug is available to be returned to the manufacturer for physical evaluation.

Manufacturer Narrative

Plant investigation: the power plug was returned to the manufacturer for physical evaluation.Upon visual inspection, the power plug shows heat damage on the hot (black) terminal in the plastic molding of the plug.The plastic molding appears to be melted from the heat.An inspection on both sides of the prong of the hot terminal has arcing and pitting.The reported physical damage was confirmed.There are no other damage on the other two terminals (neutral and ground).A continuity test (from prong to end of wire) and a resistance test (between the wires) found no discrepancies.The power plug was plugged into an outlet which was secured and could not easily be unplugged.A records review was performed on the reported machine 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 confirmed the reported event.

• Brand Name: 2008T HEMODIALYSIS SYSTEM W/BIBAG
• Type of Device: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): CONCORD MANUFACTURING; 4040 nelson avenue; concord CA 94520
• MDR Report Key: 7289514
• MDR Text Key: 100917656
• Report Number: 2937457-2018-00578
• 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: 04/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 190766
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/09/2018
• Device Age: MO
• Date Manufacturer Received: 03/13/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1