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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OGDEN MANUFACTURING PLANT OPTIFLUX 160NRE DIALYZER FINISHED ASSY. DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

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OGDEN MANUFACTURING PLANT OPTIFLUX 160NRE DIALYZER FINISHED ASSY. DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM Back to Search Results
Model Number 0500316E
Device Problem Fluid Leak (1250)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/19/2022
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 materials manager reported that a dialyzer blood leak occurred during a hemodialysis (hd) treatment. In a follow up with the hemodialysis (hd) technician it was clarified that the blood leak occurred 30 minutes into the hd treatment. The blood leak was described as being an external blood leak that was visually seen as blood was dripping from an area where the hansen meets the cylinder of the dialyzer. Blood tests strips were used and tested positive for the presence of blood. The machine was a fresenius 2008k2 machine. The machine did not alarm. There was no damage noted on the dialyzer. The patient¿s estimated blood loss (ebl) was 250 ml. There was no patient injury, adverse events, or medical intervention required as a result of this event. The patient was able to complete treatment on a different machine with new supplies. The device is available to be returned to the manufacturer for evaluation.
 
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Brand NameOPTIFLUX 160NRE 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 Key14210655
MDR Text Key290097230
Report Number0001713747-2022-00141
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 User Facility
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 06/07/2022
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 Number0500316E
Device Catalogue Number0500316E
Device Lot Number21NU06011
Was Device Available for Evaluation? No
Device AgeMO
Date Manufacturer Received05/27/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/12/2021
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: 04/26/2022 Patient Sequence Number: 1
Treatment
FRESENIUS 2008K2
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