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

Catalog Number 190618

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

Patient Problem No Patient Involvement (2645)

Event Date 01/16/2019

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 user facility reported a fresenius 2008k2 machine that powered off and gave off a burning smell.The issue occurred prior to any treatment, and there was no patient involvement.Upon follow up, it was confirmed that the machine had melted fuses that were found during repair.A fresenius (b)(4) technician replaced the burned fuses and the power switch to resolve the issue and return the machine to service.Additional information was requested, but was not provided.If additional information is provided, a supplemental report will be submitted.

Manufacturer Narrative

Plant investigation: no parts were returned to the manufacturer for physical evaluation.An on-site evaluation was performed by a fresenius mexico service technician, who reportedly repaired the machine by replacing the burned fuses and repairing the damaged power switch.The machine passed functional tests and 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.

• Brand Name: 2008K2 HEMODIALYSIS SYS OLC/DP, SPANISH
• 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; 4040 nelson avenue; concord CA 94520
• Manufacturer Contact: matthew amaral ; 920 winter st.; waltham, MA 02451 ; 7816999758
• MDR Report Key: 8339028
• MDR Text Key: 136126920
• Report Number: 2937457-2019-00498
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): N
• Reporter Country Code: MX
• PMA/PMN Number: K994267
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 03/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 190618
• Was Device Available for Evaluation?: Yes
• Device Age: MO
• Initial Date Manufacturer Received: 02/12/2019
• Initial Date FDA Received: 02/14/2019
• Supplement Dates Manufacturer Received: 03/01/2019
• Supplement Dates FDA Received: 03/05/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/14/2011
• 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