MAUDE Adverse Event Report: OGDEN MANUFACTURING PLANT OPTIFLUX 160NRE DIALYZER FINISHED ASSY. DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Catalog Number 0500316E

Device Problems Fluid Leak (1250); No Flow (2991)

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

Event Date 11/28/2018

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 biomedical technician reported an optiflux 160nre dialyzer that occluded at the beginning of a patient treatment. It was confirmed that the patient¿s blood was returned, but there was an estimated blood loss of 5ml. The patient completed treatment on the same machine with new supplies, with no injury, adverse event, or medical intervention reported. The dialyzer was discarded and is not available for return to the manufacturer.

Manufacturer Narrative

Plant investigation: the reported complaint was not confirmed as the complaint device was not returned for manufacturer evaluation. According to the biomedical technician the dialyzer was discarded; however, a photograph was provided. The photograph shows a dialyzer housing and fiber bundle. A pinkish stripe is noted in the otherwise white fibers of the dialyzer. There is no physical damage to the fibers/dialyzer visible in the photograph. A production records review was performed on the reported lot. An investigation of the device history records (dhr) was conducted by the manufacturer. There was no indication of product nonacceptance, deviation, non-conformance, rework, labeling or process control failure during the manufacturing process which could be associated with the reported event. The lot met all release criteria. A definitive conclusion regarding the complaint incident cannot be reached without physical examination of the actual device. Therefore, the complaint is not confirmed.

• Brand Name: OPTIFLUX 160NRE DIALYZER FINISHED ASSY.
• Type of Device: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): OGDEN MANUFACTURING PLANT; 475 west 13th street; ogden UT 84404
• MDR Report Key: 8169780
• MDR Text Key: 130521834
• Report Number: 1713747-2018-00492
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): N
• PMA/PMN Number: K002761
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 01/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 08/31/2021
• Device Catalogue Number: 0500316E
• Device Lot Number: 18KU06032
• Was Device Available for Evaluation?: No

Was the Report Sent to FDA?

• Device Age: MO
• Event Location: No Information
• Date Manufacturer Received: 01/16/2019
• Is This a Reprocessed and Reused Single-Use Device?: No

Patient Treatment Data

Date Received: 12/17/2018 Patient Sequence Number: 1

Treatment

FRESENIUS 2008T MACHINE; FRESENIUS BLOODLINES; FRESENIUS 2008T MACHINE; FRESENIUS BLOODLINES