MAUDE Adverse Event Report: OGDEN MANUFACTURING 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 05/12/2014

Event Type  malfunction  

Event Description

A hemodialysis inpatient user facility has reported that during treatment, a blood leak occurred.The dialyzer fibers ruptured during dialysis treatment, the leak was visually observed and the machine alarmed.Estimated blood loss was 250cc's.Patient did not required any medical intervention.Sample has not been returned to the manufacturer.

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 MANUFACTURING; ogden UT
• Manufacturer (Section G): OGDEN MANUFACTURING PLANT; 475 west 13th st.; ogden UT 84404
• Manufacturer Contact: tanya taft, rn, cnor ; 920 winter st; waltham, MA 02451 ; 8006621237
• MDR Report Key: 4002604
• MDR Text Key: 4687748
• Report Number: 1713747-2014-00286
• 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: Biomedical Engineer
• Type of Report: Initial
• Report Date: 05/12/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/10/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/01/2017
• Device Catalogue Number: 0500318E
• Device Lot Number: 14CU02014
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/12/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2014
• 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: FRESESNIUS 200K MACHINE
• Patient Age: 66 YR