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

Model Number 2008K2 HEMODIALYSIS SYS

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

Patient Problem No Patient Involvement (2645)

Event Date 02/13/2019

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 with a melted power switch and melted fuses.The issue was found when staff reported the machine would not power on prior to use.There was no patient involvement reported.Upon follow up, it was reported that a fresenius (b)(4) technician replaced the power switch fuses to resolve the issue and return the machine to service.

Manufacturer Narrative

Device codes 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 with a melted power switch and melted fuses.The issue was found when staff reported the machine would not power on.Upon follow up, it was reported that a fresenius mexico technician replaced the melted power switch and melted fuses to resolve the issue and return the machine to service.It was confirmed that no sample parts were available for return.Additional information was requested, but was not provided.If additional information is received, 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.The technician replaced the damaged/melted power rocker switch and fuses to resolve the issue and return the machine 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; director, quality systems; 4040 nelson avenue; concord CA 94520
• Manufacturer Contact: matthew amaral ; 920 winter st.; waltham, MA 02451 ; 7816999758
• MDR Report Key: 8415842
• MDR Text Key: 138636703
• Report Number: 2937457-2019-00750
• 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,Followup
• Report Date: 03/20/2019

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 Model Number: 2008K2 HEMODIALYSIS SYS
• Device Catalogue Number: 190618
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Device Age: MO
• Initial Date Manufacturer Received: 02/27/2019
• Initial Date FDA Received: 03/13/2019
• Supplement Dates Manufacturer Received: 03/19/2019; 03/20/2019
• Supplement Dates FDA Received: 03/19/2019; 03/20/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/13/2011
• 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