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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: FRESENIUS USA MANUFACTURING, INC. ADVANCED FRESENIUS POLUSULFONE OPTI 180 DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

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FRESENIUS USA MANUFACTURING, INC. ADVANCED FRESENIUS POLUSULFONE OPTI 180 DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM Back to Search Results
Lot Number 20U04019
Device Problem Leak/Splash (1354)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/09/2021
Event Type  No Answer Provided  
Event Description
Patient in dialysis. Dialyzer found to be leaking at the bottom. No harm to patient, as leak was identified during priming mod. Fresenius reported to be contacted. Fda safety report id# (b)(4).
 
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Brand NameADVANCED FRESENIUS POLUSULFONE OPTI 180
Type of DeviceDIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
Manufacturer (Section D)
FRESENIUS USA MANUFACTURING, INC.
MDR Report Key11349105
MDR Text Key232888915
Report NumberMW5099503
Device Sequence Number1
Product Code KDI
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Unknown
Type of Report Initial
Report Date 02/17/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/18/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator
Device Lot Number20U04019
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? No Answer provided
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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