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 Problem Melted (1385)

Patient Problem No Patient Involvement (2645)

Event Date 05/20/2019

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 fresenius (b)(4) technician reported that a fresenius 2008k2 hemodialysis (hd) machine had a melted component.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.Additional information was requested however to date has not been provided.

Event Description

Additional information was received by email response from the fresenius mexico technician.The machine was reviewed and repair was initially pending due to lack of spare parts.The power supply was replaced and functional tests were passed.The machine went through disinfect and was ready for use.No parts were available to be returned to the manufacturer for evaluation.

Manufacturer Narrative

Plant investigation: no parts were returned to the manufacturer for physical evaluation.A fresenius mexico technician performed an on-site investigation and replaced the damaged power supply to repair the machine.The machine passed functional testing, was disinfected and has been 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
• MDR Report Key: 8683809
• MDR Text Key: 147502246
• Report Number: 2937457-2019-01839
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): N
• PMA/PMN Number: K994267
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Type of Report: Initial,Followup
• Report Date: 06/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 190618
• Was Device Available for Evaluation?: No
• Device Age: MO
• Initial Date Manufacturer Received: 05/21/2019
• Initial Date FDA Received: 06/10/2019
• Supplement Dates Manufacturer Received: 06/11/2019
• Supplement Dates FDA Received: 06/24/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1