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 Problems Cramp(s) (2193); No Known Impact Or Consequence To Patient (2692)

Event Date 09/24/2019

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 mexico that during a hemodialysis (hd) patient's treatment the 2008k2 machine had a fluid leak coming from the back of the machine and the machine was ultrafiltrating more than expected.The patients treatment was discontinued, after the patient complained of cramps.The patient did not complete treatment and it had to be scheduled for the next day because the machine was the only one available.A fresenius mexico technician was scheduled to service the reported machine.This report was received from a list supplied by fresenius mexico.

Event Description

Upon follow up, it was reported that the equipment was inspected.The ultrafiltration (uf) pump was found to be damaged.O-rings were added to the pipettes and the uf pump was readjusted.Functional tests were performed and passed.The machine was disinfected and left ready to use.

Manufacturer Narrative

Corrected information: evaluation codes.

Manufacturer Narrative

Plant investigation: no parts were returned to the manufacturer for physical evaluation.An 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.Based on the device evaluation performed on site, the alleged event was confirmed and the cause was traced to component failure.

• 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: 9164974
• MDR Text Key: 161741545
• Report Number: 2937457-2019-03133
• 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,Followup,Followup
• Report Date: 10/25/2019

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: 10/07/2019
• Initial Date FDA Received: 10/07/2019
• Supplement Dates Manufacturer Received: 10/07/2019; 10/11/2019; 10/24/2019
• Supplement Dates FDA Received: 10/07/2019; 10/22/2019; 10/25/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1