MAUDE Adverse Event Report: OGDEN MANUFCATURING OPTIFLUX 180NRE DIALYZER FINISHED ASSY.

Catalog Number 0500318E

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.The unit stated that the dialyzer had an integrity failure.The dialyzer membrane ruptured causing the machine to alarm a blood leak.Blood test strips were used and there was blood in the dialysate.Estimated blood loss was 200cc's.Pt had no adverse effects.Sample is not available; sample was discarded.

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 180NRE DIALYZER FINISHED ASSY.
• Manufacturer (Section D): OGDEN MANUFCATURING; ogden UT
• Manufacturer (Section G): OGDEN MANUFACTURING PLANT; 475 west 13th st.; ogden UT 84404
• Manufacturer Contact: jennifer nabukenya ; 920 winter st; waltham, MA 02451 ; 8006621237
• MDR Report Key: 3929899
• MDR Text Key: 4588491
• Report Number: 1713747-2014-00101
• Device Sequence Number: 1
• Product Code: FJI
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 02/10/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/01/2016
• Device Catalogue Number: 0500318E
• Device Lot Number: 13NU05010
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/10/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2013
• 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: FRESENIUS 2008K MACHINE
• Patient Age: 38 YR