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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 04/21/2022
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 internal dialyzer blood leak occurred two minutes after the start of a patient¿s hemodialysis (hd) treatment. The blood leak was visually observed from tube of the red hansen line and internally within the dialyzer. The machine, a fresenius 2008t, alarmed appropriately with a blood leak alert. Fresenius combi set bloodlines were being utilized for the treatment. Blood test strips were used and tested positive for the presence of blood. It was also stated the blood was visually noted and the treatment was stopped immediately. No damage was identified on the dialyzer prior to use. Immediately following the event, the patient was re-setup with new supplies on a different machine where they were able to complete treatment. The patient¿s estimated blood loss (ebl) was 300 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 available to be returned for a manufacturer evaluation.
 
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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 Key14210458
MDR Text Key290546090
Report Number0001713747-2022-00140
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 Administrator/Supervisor
Type of Report Initial
Report Date 04/26/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/26/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number0500318E
Device Catalogue Number0500318E
Device Lot Number22BU02005
Was Device Available for Evaluation? Yes
Device AgeMO
Date Manufacturer Received04/21/2022
Was Device Evaluated by Manufacturer? No
Date Device Manufactured02/14/2022
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: 04/26/2022 Patient Sequence Number: 1
Treatment
FRESENIUS 2008T MACHINE; FRESENIUS BLOODLINES
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