* PRISMAFLEX

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2009-12-13 for * PRISMAFLEX manufactured by Gambro Renal Products, Inc..

Event Text Entries

[1394845] Patient on continuous renal replacement therapy. Machine alarmed that there was excess fluid removal. Noticed that the previous hour there was more fluid removed than the pump was set. Following this observation the pump began to alarm that there was excess fluid removed. Patient experienced no distress or harm from this.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1562042
MDR Report Key1562042
Date Received2009-12-13
Date of Report2009-12-13
Date of Event2009-11-26
Report Date2009-12-13
Date Reported to FDA2009-12-13
Date Added to Maude2009-12-18
Event Key0
Report Source CodeUser Facility report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Reporter OccupationRISK MANAGER
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand Name*
Generic NameHEMODIALYSIS MACHINE, CONTINUOUS RENAL REPLACEMENT THERAPY
Product CodeFII
Date Received2009-12-13
Model NumberPRISMAFLEX
Catalog Number*
Lot Number*
ID Number*
OperatorNURSE
Device AvailabilityY
Device Age6 MO
Device Sequence No1
Device Event Key0
ManufacturerGAMBRO RENAL PRODUCTS, INC.
Manufacturer Address14143 DENVER WEST PARKWAY, SUI LAKEWOOD CO 80401 US 80401


Patients

Patient NumberTreatmentOutcomeDate
10 2009-12-13

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