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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OGDEN MANUFACTURING PLANT OPTIFLUX 160NRE DIALYZER FINISHED ASSY.; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
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OGDEN MANUFACTURING PLANT OPTIFLUX 160NRE DIALYZER FINISHED ASSY.; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM Back to Search Results
Catalog Number 0500316E
Device Problem Obstruction of Flow (2423)
Patient Problem Hemorrhage/Bleeding (1888)
Event Date 01/26/2024
Event Type  malfunction  
Event Description
It was reported to fresenius that the membranes of an optiflux 160nre dialyzer were occluded during a patient's hemodialysis (hd) treatment, which prevented fluid from passing through.To address the problem, the staff immediately replaced the device with a new one.On the intake form it was reported that the event resulted in blood loss.The intake also indicated the sample was not available to be returned for evaluation.Multiple attempts have been made to obtain additional information, and thus far no further details have been provided.
 
Manufacturer Narrative
The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.
 
Event Description
It was reported to fresenius that the membranes of an optiflux 160nre dialyzer were occluded during a patient's hemodialysis (hd) treatment, which prevented fluid from passing through.To address the problem, the staff immediately replaced the device with a new one.On the intake form it was reported that the event resulted in blood loss.The intake also indicated the sample was not available to be returned for evaluation.Multiple attempts have been made to obtain additional information, and thus far no further details have been provided.
 
Manufacturer Narrative
Plant investigation: the complaint device was not returned to the manufacturer for physical evaluation.However, two photos were provided for review.The first photo shows the dialyzer connected to a machine, where blood can be seen in the header and the fiber bundle appears to be streaked.The second photo shows the same dialyzer from another angle.The streaking observed in the photos is indicative of occluded fibers.A production records review was performed on the reported lot.An investigation of the device history records (dhr) was then conducted by the manufacturer.There were multiple approved temporary deviation notices (dns) in the production of this lot which were unrelated to the complaint event.There was no indication of product nonacceptance, deviation, non-conformance, rework, labeling or process control failure during the manufacturing process which could be associated with the reported event.The lot met all release criteria.The complaint was confirmed with the provided photos.The probable causes for a streaked fiber bundle / perception of inadequate fill are the injection of an excess of pre-potting polyurethane (pu), insufficient pre-potting pu, uneven distribution of pu, or a decreased gel time of the pu.All of these can cause the pu to wick into the fiber past the final cut and plug some of the fibers on the peripheral of the cutting surface.
 
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Brand Name
OPTIFLUX 160NRE DIALYZER FINISHED ASSY.
Type of Device
DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
Manufacturer (Section D)
OGDEN MANUFACTURING PLANT
director, site quality
475 west 13th street
ogden UT 84404
Manufacturer (Section G)
OGDEN MANUFACTURING PLANT
director, site quality
475 west 13th street
ogden UT 84404
Manufacturer Contact
jessica trujillo
920 winter st
waltham, MA 02451
6174175172
MDR Report Key18735501
MDR Text Key336864422
Report Number0001713747-2024-00101
Device Sequence Number1
Product Code KDI
UDI-Device Identifier00840861100149
UDI-Public00840861100149
Combination Product (y/n)N
Reporter Country CodeMX
PMA/PMN Number
K162488
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,User Facility
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 03/06/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number0500316E
Device Lot Number23NU06031
Was Device Available for Evaluation? No
Device AgeMO
Initial Date Manufacturer Received 01/29/2024
Initial Date FDA Received02/19/2024
Supplement Dates Manufacturer Received02/28/2024
Supplement Dates FDA Received03/06/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/29/2023
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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