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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 04/25/2022
Event Type  malfunction  
Manufacturer Narrative
Plant investigation: the plant investigation is in process. A supplemental mdr will be submitted upon completion of this activity.
 
Event Description
A user facility nurse reported that an external dialyzer blood leak occurred six minutes after the start of a patient¿s hemodialysis (hd) treatment. The nursing staff was able to detect the leak and was observed from the venous head of the dialyzer. The machine, a fresenius 4008s, did not alarm with a blood leak alert and blood test strips were not used. Non-fresenius bloodlines were being utilized for the treatment. No damage was identified on the dialyzer prior to use. Immediately following the event, the patient was re-setup with new supplies on the same machine where they were able to complete treatment. The patient¿s estimated blood loss (ebl) was 100 ml. It was 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 dialyzer was not available to be returned for a manufacturer evaluation as it was reportedly discarded.
 
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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
jason busch
920 winter st
waltham, MA 02451
9043166958
MDR Report Key14238629
MDR Text Key290806163
Report Number0001713747-2022-00149
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 Health Professional,User Facility,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/16/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/28/2022
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 Received05/16/2022
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: 04/28/2022 Patient Sequence Number: 1
Treatment
FRESENIUS 4008S MACHINE
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