PRISMAFLEX

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-06-13 for PRISMAFLEX manufactured by Gambro Renal Products, Inc..

Event Text Entries

[47204035]
Patient Sequence No: 1, Text Type: N, H10


[47204036] Prisma machine screen went white; nothing visible, machine continued to run.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number5719814
MDR Report Key5719814
Date Received2016-06-13
Date of Report2016-05-20
Date of Event2016-01-27
Report Date2016-05-20
Date Reported to FDA2016-05-20
Date Reported to Mfgr2016-05-20
Date Added to Maude2016-06-13
Event Key0
Report Source CodeUser Facility report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag0
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NamePRISMAFLEX
Generic NameDIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
Product CodeMDP
Date Received2016-06-13
Model NumberPRISMAFLEX
OperatorNURSE
Device AvailabilityY
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerGAMBRO RENAL PRODUCTS, INC.
Manufacturer Address9540 MAROON CIRCLE FLOOR 4 ENGLEWOOD CO 80112 US 80112


Patients

Patient NumberTreatmentOutcomeDate
10 2016-06-13

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