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 04/18/2019

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

A biomedical technician (biomed) at a user facility reported that a fresenius 2008t hemodialysis (hd) machine had a visibly burned and melted power plug.The burned power plug was noticed during regular inspection.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 the original fresenius part on the machine.The biomed reported that there was no burning smell, smoke, spark, flame, or arcing 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 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 an electrician replaced the gfci outlets at the clinic as well, as many of the outlets appeared loose.The biomed reported that the machine has been returned to service without issue.The power plug was reported to be available to be returned to the manufacturer for physical evaluation.

Manufacturer Narrative

Plant investigation: no parts were returned to the manufacturer for physical evaluation.Additionally, no on-site evaluation was performed by a fresenius regional equipment specialist (res).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.

• 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
• Manufacturer (Section G): CONCORD MANUFACTURING; director, quality systems; 4040 nelson avenue; concord CA 94520
• Manufacturer Contact: matthew amaral ; 920 winter st.; waltham, MA 02451 ; 7816999758
• MDR Report Key: 8566363
• MDR Text Key: 143602370
• Report Number: 2937457-2019-01267
• Device Sequence Number: 1
• Product Code: KDI
• UDI-Device Identifier: 00840861100910
• UDI-Public: 00840861100910
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K121341
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 05/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/30/2019
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 190766
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Date Manufacturer Received: 05/10/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/16/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1