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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: FRESENIUS MEDICAL CARE NORTH AMERICA, OGDEN MANUFACTURING OPTIFLUX 180NRE DIALYZER FINISHED ASSY.
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FRESENIUS MEDICAL CARE NORTH AMERICA, OGDEN MANUFACTURING OPTIFLUX 180NRE DIALYZER FINISHED ASSY. Back to Search Results
Catalog Number 0500318E
Device Problems Crack (1135); Fluid/Blood Leak (1250); Material Rupture (1546)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/07/2014
Event Type  malfunction  
Event Description
A hemodialysis inpatient user facility reported that during treatment, a blood leak occurred.The membrane was ruptured and the dialyzer head was cracked.Estimated blood loss was 300 cc's.The patient had no adverse estimated.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.
 
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Brand Name
OPTIFLUX 180NRE DIALYZER FINISHED ASSY.
Manufacturer (Section D)
FRESENIUS MEDICAL CARE NORTH AMERICA, 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 street
waltham, MA 02451
8006621237
MDR Report Key4024155
MDR Text Key4730082
Report Number1713747-2014-00384
Device Sequence Number1
Product Code FJI
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K002761
Number of Events Reported1
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 07/08/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/05/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date04/01/2017
Device Catalogue Number0500318E
Device Lot Number14DU03007
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received07/08/2014
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/01/2014
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
FRESENIUS 2008K MACHINE
Patient Age38 YR
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