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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: FRESENIUS MEDICAL CARE NORTH AMERICA DIALYZER DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

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FRESENIUS MEDICAL CARE NORTH AMERICA DIALYZER DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM Back to Search Results
Model Number F180NR OPTIFLUX
Device Problem Fluid Leak (1250)
Patient Problem Hemorrhage/Bleeding (1888)
Event Date 06/23/2022
Event Type  Injury  
Event Description
Major blood leak from fresenius f180nr dialyzer with no visible defect. Fda safety report id # (b)(4).
 
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Brand NameDIALYZER
Type of DeviceDIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
Manufacturer (Section D)
FRESENIUS MEDICAL CARE NORTH AMERICA
MDR Report Key14958226
MDR Text Key295671580
Report NumberMW5110760
Device Sequence Number1
Product Code KDI
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Administrator/Supervisor
Type of Report Initial
Report Date 07/06/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/07/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberF180NR OPTIFLUX
Device Lot Number22DU02006
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 07/07/2022 Patient Sequence Number: 1
Treatment
OTHER MEDICAL PRODUCTS: GAMBRO CARTRIDGE BLOOD SET.
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