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)

Patient Problem No Patient Involvement (2645)

Event Date 07/12/2018

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 biomed reported that there was no burning smell, smoke, spark, or flame observed.The plug was noticed during machine setup.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 machine has approximately 1,401 hours and the power plug was the original fresenius part on the machine.A fresenius regional equipment specialist (res) performed an on-site evaluation of the machine.The res checked the power supply and did not see any damage or burned components.The res tested the facility outlets with a receptacle tension tester and found some outlets with less than 4 ounces at either the hot, neutral, or ground prong.Per the res, all prongs should read greater than 4 ounces and a loose plug will cause arcing.The res replaced the power plug and advised facility to schedule an electrician to come out and test or replace the outlets.The res stated that there were no other problems found.Following part replacement, the res performed functional checks and confirmed the machine was operating properly.The biomed reported that the unit was returned to service at the user facility without reoccurrence of the event.The biomed reported that the power plug was discarded and is not available to be returned to the manufacturer for physical evaluation.

Manufacturer Narrative

No parts were returned to the manufacturer for physical evaluation.The 2008t hemodialysis (hd) machine was evaluated at the facility by the fresenius regional equipment specialist (res) due to a burned power plug.The res tested the facility outlets with a receptacle tension tester and found some outlets with less than 4 ounces at either the hot, neutral, or ground prong.Per the res, all prongs should read greater than 4 ounces and a loose plug will cause arcing.The res replaced the power plug and advised facility to schedule an electrician to come out and test or replace the outlets.After the repairs, machine functional checks were performed, and all tests found the unit to be functioning within specification.A records review was performed on the reported device serial number.An investigation of the device manufacturing records was conducted by the manufacturer.There were no non-conformances, or any associated rework during the manufacturing process which could be related to the reported event.Additionally, a review of the device history record (dhr) confirmed the results of the in-progress and final quality control (qc) testing met all the requirements.The investigation into the cause of the complaint was able to confirm 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: 7722670
• MDR Text Key: 115195869
• Report Number: 2937457-2018-02144
• 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: user facility
• Type of Report: Initial,Followup
• Report Date: 08/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/26/2018
• 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?: Yes
• Device Age: MO
• Date Manufacturer Received: 08/23/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1