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 Thermal Decomposition of Device (1071); Smoking (1585)

Patient Problem No Patient Involvement (2645)

Event Date 04/30/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported through a research article identifying st.Jude's mechanical mitral valves, mechanical aortic valves, and porcine valve (mitral valve) chosen for valve replacement surgeries.240 patients were in the study in which 59 of the devices were abbott valves.The patient has an average age of 19 years old, 136 of them being female.Details are listed in the article, titled, "contemporary outcomes of aortic and mitral valve surgery for rheumatic heart disease in (b)(6)".There were 3 patients that died within 30 days post procedure.However, it is not indicated if any of these patients that died had an abbott valve implanted.

Manufacturer Narrative

Additional information: h3 plant investigation: although the damaged parts were reported to be available for manufacturer evaluation, to date no samples have been received.However, an on-site evaluation was performed by a fresenius field service technician (fst).The fst identified that the power cable was not properly connected to the power supply, and they reseated it.The fst also confirmed finding burn marks and charring on the actuator test board, the interface board, and the power logic board.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 fresenius fst identified burn damage on multiple boards and the appropriate replacement parts were ordered.Therefore, the reported complaint event was 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: 10084338
• MDR Text Key: 191956719
• Report Number: 2937457-2020-00912
• 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: 06/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/22/2020
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 190766
• Device Catalogue Number: 190766
• Was Device Available for Evaluation?: Yes
• Device Age: MO
• Date Manufacturer Received: 05/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1