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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 Leak (1250)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/18/2022
Event Type  malfunction  
Event Description
A user facility reported that a dialyzer blood leak occurred immediately after the initiation of the patient¿s hemodialysis (hd) treatment. The blood leak was noted as being an internal blood leak. The leak was visually observed on the arterial end of the dialyzer. The machine, a fresenius 2008t machine, alarmed appropriately with a blood leak alarm. Blood leak test strips were not used as the leak was visually observed. There was no patient injury, adverse events, or medical intervention required as a result of this event. The patient was restarted on the machine and treatment completed successfully with new supplies. The complaint device was reported to be available to be returned to the manufacturer for evaluation. Additional information was requested however to date has not been provided.
 
Manufacturer Narrative
The plant investigation is in process. A supplemental mdr will be submitted upon completion of this activity.  .
 
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Brand NameOPTIFLUX 180NRE DIALYZER FINISHED ASSY.
Type of DeviceDIALYZER, 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 Key14336613
MDR Text Key291242140
Report Number0001713747-2022-00153
Device Sequence Number1
Product Code KDI
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K162488
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,User Facility
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 05/27/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/09/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date04/18/2022
Device Model Number0500318E
Device Catalogue Number0500318E
Device Lot Number21LU02017
Was Device Available for Evaluation? No
Device AgeMO
Date Manufacturer Received05/16/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/26/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 05/09/2022 Patient Sequence Number: 1
Treatment
FRESENIUS 2008T MACHINE; FRESENIUS BLOODLINES
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