MAUDE Adverse Event Report: CONCORD MANUFACTURING 2008K HEMODIALYSIS SYS. OLC/DIASAFE PLUS; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Catalog Number 190371

Device Problem Inadequate Filtration Process (2308)

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

Event Date 07/01/2019

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 nurse reported that the fresenius 2008k hemodialysis (hd) machine did not remove enough weight during treatment.It was set to remove 4500 ml and the ultrafiltration (uf) removed showed 4500 ml.When they weighed the patient, there was only about 200 ml weight loss.Additional information was requested, however to date not provided.

Manufacturer Narrative

Plant investigation: no parts were returned to the manufacturer for physical evaluation.Additionally, no on-site evaluation was performed by a fresenius regional equipment specialist (res).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 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.

• Brand Name: 2008K HEMODIALYSIS SYS. OLC/DIASAFE PLUS
• 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: 8789060
• MDR Text Key: 150986954
• Report Number: 2937457-2019-02154
• 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: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 07/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/15/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 190371
• Was Device Available for Evaluation?: No
• Device Age: MO
• Date Manufacturer Received: 07/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1