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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 04/29/2022
Event Type  malfunction  
Event Description
A user facility nurse 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 that could be visually observed within the hansen connection. The blood leak occurred and was observed before reaching the blood leak detector on the machine, a fresenius 4008s machine, to trigger a blood leak alarm. Blood leak test strips were not used to test for the presence of blood. There was no defect or damage noted on the dialyzer. The patient¿s estimated blood loss (ebl) was approximately 200 ml. There was no patient injury, adverse events, or medical intervention required as a result of this event. The patient was restarted on a new machine and treatment completed successfully with new supplies. The complaint device was reported to be unavailable to be returned to the manufacturer for evaluation.
 
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 Key14399711
MDR Text Key292219562
Report Number0001713747-2022-00160
Device Sequence Number1
Product Code KDI
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,Health Professional,User Facility,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/02/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/13/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number0500318E
Device Catalogue Number0500318E
Device Lot Number21SU02014
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Device AgeMO
Date Manufacturer Received05/19/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/26/2021
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: 05/13/2022 Patient Sequence Number: 1
Treatment
FRESENIUS 4008S MACHINE
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