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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OGDEN MANUFACTURING PLANT OPTIFLUX 180NRE DIALYZER FINISHED ASSY.; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

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OGDEN MANUFACTURING PLANT OPTIFLUX 180NRE DIALYZER FINISHED ASSY.; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM Back to Search Results
Model Number 0500318E
Device Problem Fluid/Blood Leak (1250)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/03/2020
Event Type  malfunction  
Manufacturer Narrative
The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.
 
Event Description
A user facility clinical care hemodialysis technician (ccht) reported that an internal dialyzer blood leak occurred at the start of a patient¿s hemodialysis (hd) treatment.The blood leak was visible in the dialysate compartment of the device.A blood test strip was used and tested positive for the presence of blood.It was confirmed that the machine, a fresenius 2008t, alarmed appropriately with a blood leak alert.No visible damage was identified on the dialyzer; however, the fibers were thought to be ruptured due to the presence of blood in the dialysate compartment.After the machine alarmed, the treatment was halted.The patient¿s blood was not returned; estimated blood loss (ebl) was 200 ml.The ccht confirmed there was no patient injury, no adverse effects were experienced, and no medical intervention was required as a result of the reported event.The patient completed their treatment after being re-setup with new supplies on a different machine.The dialyzer was not available to be returned to the manufacturer for physical evaluation; it was reported that the device was discarded.
 
Manufacturer Narrative
Plant investigation: the reported complaint was not confirmed as the complaint device was not returned for manufacturer evaluation.A production records review was performed on the reported lot.An investigation of the device history records (dhr) was conducted by the manufacturer.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.A definitive conclusion regarding the complaint incident cannot be reached without physical examination of the actual device.Therefore, the complaint is not confirmed.
 
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Brand Name
OPTIFLUX 180NRE 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
MDR Report Key10993298
MDR Text Key221536444
Report Number1713747-2020-00513
Device Sequence Number1
Product Code KDI
UDI-Device Identifier00840861100156
UDI-Public00840861100156
Combination Product (y/n)N
PMA/PMN Number
K002761
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,user f
Type of Report Initial,Followup
Report Date 01/27/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/11/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date09/30/2023
Device Model Number0500318E
Device Catalogue Number0500318E
Device Lot Number20LU02002
Was Device Available for Evaluation? No
Device AgeMO
Date Manufacturer Received01/18/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
FRESENIUS 2008T MACHINE; FRESENIUS BLOODLINES
Patient Weight79
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