MAUDE Adverse Event Report: CONCORD MANUFACTURING 2008T HEMODIALYSIS SYSTEM W/BIBAG DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Catalog Number 190766

Device Problem Alarm Not Visible (1022)

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

Event Date 04/25/2018

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 clinic manager reported that a dialyzer blood leak occurred immediately into patient¿s hemodialysis (hd) treatment. The blood leak was noted as being an internal blood leak. The leak was visually observed at as bright red tinge on the dialysate at the bottom of the dialyzer. The machine, a fresenius 2008t machine, did not alarm appropriately with a blood leak alarm. The patient¿s estimated blood loss (ebl) was approximately 100 ml. There was no patient injury, adverse events, or medical intervention required as a result of this event. The patient was restarted on a new machine and treatment completed successfully with new supplies. The in-house biomedical technician (biomed) stated that the machine was evaluated and passed functional checks.

Manufacturer Narrative

The device was not returned to the manufacturer for physical evaluation. Additionally, no on-site evaluation of the unit was performed by a fresenius regional equipment specialist (res) and no parts were returned for failure analysis. The biomedical engineer indicated that the unit was pulled from service for evaluation following the event. Functional testing performed by the biomed confirmed that the system was operating properly. The 2008t hemodialysis (hd) machine was returned to service at the user facility without issue. The 2008t hemodialysis (hd) machine was returned to service at the user facility without issue. 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 deviations or non-conformances during the manufacturing process. In addition, a device history record (dhr) review was performed and verified that the results of the in-progress and final quality control (qc) testing met all requirements. A definitive conclusion regarding the complaint incident cannot be reached without a physical examination of the complaint device. Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: 2008T HEMODIALYSIS SYSTEM W/BIBAG
• 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: 7504270
• MDR Text Key: 108146407
• Report Number: 2937457-2018-01308
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): N
• PMA/PMN Number: K121341
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 05/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/10/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Catalogue Number: 190766
• Was Device Available for Evaluation?: No

Was the Report Sent to FDA?

• Device Age: MO
• Event Location: No Information
• Date Manufacturer Received: 05/16/2018
• Is This a Reprocessed and Reused Single-Use Device?: No

Patient Treatment Data

Date Received: 05/10/2018 Patient Sequence Number: 1

Treatment

OPTIFLUX 180NRE DIALYZER FINISHED ASSY.