MAUDE Adverse Event Report: OGDEN MANUFACTURING F80A DIALYZER FINISHED ASSY

Catalog Number 0500154A

Device Problem Fluid/Blood Leak (1250)

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

Event Date 01/31/2014

Event Type  malfunction  

Event Description

A hemodialysis inpatient user facility has reported that during treatment, a blood leak occurred.The leak was visually observed from the head of the dialyzer and the machine alarmed.Estimated blood loss was 20cc's.Pt had no adverse effects and required no medical intervention.Sample has not been returned to the mfr.

Manufacturer Narrative

The plant investigation has not yet been completed.A f/u report will be filed upon completion of the investigation.

• Brand Name: F80A 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 st.; waltham, MA 02451 ; 8006621237
• MDR Report Key: 3837857
• MDR Text Key: 4454592
• Report Number: 1713747-2014-00094
• Device Sequence Number: 1
• Product Code: MSE
• Combination Product (y/n): N
• Reporter Country Code: MX
• PMA/PMN Number: K970700
• 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: 02/04/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/01/2016
• Device Catalogue Number: 0500154A
• Device Lot Number: 13EU03006
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/04/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2013
• 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: 4008S MACHINE
• Patient Age: 51 YR