REVACLEAR 400 114746L

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-19 for REVACLEAR 400 114746L manufactured by Gambro Renal Products, Inc..

Event Text Entries

[184119270] Blood leaking from dialyzer header 12 mins into treatment. Crack noted and treatment stopped. No blood return. Patient stable and no any sign of distress. New set up established and treatment restarted. Notified doctor. Ordered to write down the dialyzer lot number. No others.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number9853294
MDR Report Key9853294
Date Received2020-03-19
Date of Report2020-02-12
Date of Event2019-10-12
Report Date2020-02-12
Date Reported to FDA2020-02-12
Date Reported to Mfgr2020-03-19
Date Added to Maude2020-03-19
Event Key0
Report Source CodeUser Facility report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag0
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameREVACLEAR
Generic NameDIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
Product CodeKDI
Date Received2020-03-19
Model Number400
Catalog Number114746L
Lot NumberC619407704
Device Availability*
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerGAMBRO RENAL PRODUCTS, INC.
Manufacturer Address1101 JETER AVENUE OPELIKA AL 36801 US 36801


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-19

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