MAUDE Adverse Event Report: CONCORD MANUFACTURING 2008K2 HEMODIALYSIS SYS. OLC/DIASAFE PLS; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Catalog Number 190610

Device Problems Thermal Decomposition of Device (1071); Smoking (1585); Arcing (2583)

Patient Problem No Patient Involvement (2645)

Event Date 02/13/2018

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 2008k2 hemodialysis (hd) machine had a power plug that was burned and showed signs of shorting and arcing.The power plug was cracked in multiple locations and separation of the wires was observed.The damaged power plug was noticed during heat disinfection when a burning smell and smoke was emitted from the plug.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 plug was not the original part on the machine, however, is a fresenius part.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 biomed stated that the machine is not plugged into a hospital grade ground-fault circuit interrupter (gfci) outlet, but in an emergency hospital power outlet instead.The biomed replaced the plug, which resolved the issue.The biomed reported that the machine has been returned to service without reoccurrence of the reported event.The power plug was stated to be available to be returned to the manufacturer for physical evaluation.

Manufacturer Narrative

Plant investigation: although it was stated that the parts were available to be returned to the manufacturer for physical evaluation, to date, no parts have been returned.Additionally, no on-site evaluation was performed by a fresenius regional equipment specialist (res).The reported burned and melted power plug was replaced and the machine returned to service.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.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: 2008K2 HEMODIALYSIS SYS. OLC/DIASAFE PLS
• 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: 7307451
• MDR Text Key: 101478096
• Report Number: 2937457-2018-00647
• Device Sequence Number: 1
• Product Code: KDI
• UDI-Device Identifier: 00840861100859
• UDI-Public: 00840861100859
• Combination Product (y/n): N
• PMA/PMN Number: K994267
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 03/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 190610
• Was Device Available for Evaluation?: No
• Device Age: MO
• Date Manufacturer Received: 03/13/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1