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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: FRESENIUS MEDICAL CARE OPTIFLUX 180NRE DIALYZER; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
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FRESENIUS MEDICAL CARE OPTIFLUX 180NRE DIALYZER; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM Back to Search Results
Device Problems Complete Blockage (1094); Fluid/Blood Leak (1250)
Patient Problem Insufficient Information (4580)
Event Type  Injury  
Event Description
It was reported that a hemodialysis (hd) patient experienced a dialyzer blood leak during treatment.The patient was approximately one hour into treatment when the fresenius 2008k2 machine alarmed with a blood leak alert.The patient was utilizing the optiflux 180nre dialyzer.The patient's treatment was discontinued, and the blood was not returned.The estimated blood loss was 250 ml.There was no adverse event as a result of the blood loss and the patient did not require any medical intervention for the blood loss.After the patient was removed from the machine it was determined that their dialysis access was clotted.The staff determined this was not an emergency; however, the patient did not complete treatment.The patient was sent back to their residence at the nursing home.Once the patient was at the nursing home (time not provided) it was determined the patient should be transported to the hospital in order to have the dialysis access declotted.The patient's access was declotted and no further intervention was required.Fresenius complaint record: (b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).
 
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Brand Name
OPTIFLUX 180NRE DIALYZER
Type of Device
DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
Manufacturer (Section D)
FRESENIUS MEDICAL CARE
MDR Report Key17533492
MDR Text Key321150071
Report NumberMW5140396
Device Sequence Number1
Product Code KDI
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Other
Type of Report Initial
Report Date 07/27/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/12/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Patient Sequence Number1
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