MAUDE Adverse Event Report: OGDEN MANUFACTURING OPTIFLUX 200NRE DIALYZER FINISHED ASSY.

Catalog Number 0500320E

Device Problems Fluid/Blood Leak (1250); Material Rupture (1546)

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

Event Date 02/07/2014

Event Type  malfunction  

Event Description

A hemodialysis inpatient user facility has reported that during treatment, a blood leak occurred.Facility reported that staff had issues with patient access during treatment and machine was put in circulation for about 30 minutes.While trying to put patient back onto machine, blood leak alarm occurred.There was a rupture in the dialyzer.The patient lost 300ml of blood and there are no patient ill effects.Sample is not available.

Manufacturer Narrative

The plant investigation has not yet been completed.A follow up report will be filed upon completion of the investigation.

• Brand Name: OPTIFLUX 200NRE DIALYZER FINISHED ASSY.
• Manufacturer (Section D): OGDEN MANUFACTURING; ogden UT
• Manufacturer (Section G): OGDEN MANUFACTURING PLANT; 475 west 13th st.; ogden UT 84404
• Manufacturer Contact: jennifer nabukenya ; 920 winter street; waltham, MA 02451 ; 8006621237
• MDR Report Key: 3930046
• MDR Text Key: 4599139
• Report Number: 1713747-2014-00114
• Device Sequence Number: 1
• Product Code: FJI
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K002761
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/07/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/10/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/01/2016
• Device Catalogue Number: 0500320E
• Device Lot Number: 13PU04005
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/11/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: 5008 HEMODIALYSIS MACHINE