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 Inadequate Ultra Filtration (1656)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/18/2019

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 customer reported to fresenius (b)(4) that a 2008k2 machine had no ultrafiltration during patient treatment.The patient was able to complete treatment on the same machine.There were no reported adverse events or medical intervention required as a result of the reported event.

Manufacturer Narrative

Additional information: additional information was received from the biomedical technician and added to b5.Plant investigation: plant investigation: no parts were returned to the manufacturer for physical evaluation.The biomedical technician replaced the pressure relief valve, calibrated the flow pressure, and checked the functionality in dialysis mode.The machine was tested and functioned properly.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.

Event Description

A customer reported to fresenius mexico that a 2008k2 machine had no ultrafiltration during patient treatment.The patient was able to complete treatment on the same machine.There were no reported adverse events or medical intervention required as a result of the reported event.Additional information was requested, however to date has not been received.The biomedical technician provided further information regarding service of the device.It was reported by the biomedical technician that there is a leak in the pressure relief valve.The biomedical technician replaced the pressure relief valve, calibrated the flow pressure, and checked the functionality in dialysis mode.The machine was tested and was able to function correctly.

• 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; director, quality systems; 4040 nelson avenue; concord CA 94520
• MDR Report Key: 9530543
• MDR Text Key: 179337463
• Report Number: 2937457-2019-03660
• 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: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 01/14/2020

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: 12/19/2019
• Initial Date FDA Received: 12/30/2019
• Supplement Dates Manufacturer Received: 01/03/2020
• Supplement Dates FDA Received: 01/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1