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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: FRESENIUS USA MANUFACTURING, INC. OPTIFLUX DIALYZER DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

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FRESENIUS USA MANUFACTURING, INC. OPTIFLUX DIALYZER DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM Back to Search Results
Lot Number 20SU01020
Device Problem Leak/Splash (1354)
Patient Problem Insufficient Information (4580)
Event Date 04/09/2021
Event Type  malfunction  
Event Description
Patient was transferred to the dialysis unit for treatment. Several minutes into treatment. A blood leak was detected. There was visible blood in the dialysate. Treatment was immediately terminated. Blood was not returned; 10 ml of blood withdrawn from each needle site prior to flushing each needle. No effects noted to patient. Fda safety report id# (b)(4).
 
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Brand NameOPTIFLUX DIALYZER
Type of DeviceDIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
Manufacturer (Section D)
FRESENIUS USA MANUFACTURING, INC.
MDR Report Key11677818
MDR Text Key246001309
Report NumberMW5100805
Device Sequence Number1
Product Code KDI
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 04/14/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/15/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Lot Number20SU01020
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

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