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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: FRESENIUS MEDICAL CARE NORTH AMERICA OPTIFLUX 180 DIALYZER DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

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FRESENIUS MEDICAL CARE NORTH AMERICA OPTIFLUX 180 DIALYZER DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM Back to Search Results
Lot Number 21PU02019
Device Problem Fluid Leak (1250)
Patient Problem Hemorrhage/Bleeding (1888)
Event Date 02/08/2022
Event Type  Injury  
Event Description
Blood leak alarm detected on machine. Unable to reset. Verified blood leak. Blood not returned to pt. Lines and dialyzer discarded. New system setup. Fda safety report id# (b)(4).
 
Event Description
Blood leak alarm detected on machine. Unable to reset. Verified blood leak. Blood not returned to pt. Lines and dialyzer discarded. New system setup. Fda safety report id# (b)(4).
 
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Brand NameOPTIFLUX 180 DIALYZER
Type of DeviceDIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
Manufacturer (Section D)
FRESENIUS MEDICAL CARE NORTH AMERICA
waltham MA 02451
MDR Report Key13584140
MDR Text Key286072144
Report NumberMW5107613
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 Risk Manager
Type of Report Initial
Report Date 02/17/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/22/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Lot Number21PU02019
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes

Patient Treatment Data
Date Received: 02/22/2022 Patient Sequence Number: 1
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