FRESENIUS HEMODIALYZER F8 NA

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2004-03-15 for FRESENIUS HEMODIALYZER F8 NA manufactured by Fresenius Medical Care.

Event Text Entries

[364760] Pt experienced chills and fever during hemodialysis therapy. Therapy was provided with a 7th-use hemodialysis.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number518709
MDR Report Key518709
Date Received2004-03-15
Date of Report2003-12-31
Date of Event2003-12-16
Date Facility Aware2003-12-16
Report Date2003-12-31
Date Reported to Mfgr2003-12-31
Date Added to Maude2004-04-05
Event Key0
Report Source CodeUser Facility report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Sequence Number: 1

Brand NameFRESENIUS HEMODIALYZER
Generic NameHEMODIALYZER
Product CodeFKP
Date Received2004-03-15
Model NumberF8
Catalog NumberNA
Lot NumberUNK
ID NumberNA
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeUNKNOWN
Implant FlagN
Date RemovedA
Device Sequence No1
Device Event Key507739
ManufacturerFRESENIUS MEDICAL CARE
Manufacturer Address95 HAYDEN AVE LEXINGTON MA 02420 US

Device Sequence Number: 2

Brand NameRENATRON
Generic NameREPROCESSING DEVICE
Product CodeLIF
Date Received2004-03-15
Model NumberRS8330
Catalog NumberNA
Lot NumberUNK
ID NumberNA
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeUNKNOWN
Implant FlagN
Date RemovedA
Device Sequence No2
Device Event Key521352
ManufacturerMINNTECH CORP.
Manufacturer Address14605 28TH AVE NORTH MINNEAPOLIS MN 55447 US


Patients

Patient NumberTreatmentOutcomeDate
101. Hospitalization; 2. Other 2004-03-15

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