PRISMASATE 500 CC DIALYSIS SOLUTION

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2009-12-28 for PRISMASATE 500 CC DIALYSIS SOLUTION manufactured by Gambro.

Event Text Entries

[17527854] Two (2) prismasate dialysis solution bags for continuous renal replacement therapy by gambro -both were 5000cc each- split for pt. We had to remake the bags. Dose or amount: 5000cc. Frequency: continuous. Route: iv. Dates of: 2009. Diagnosis or reason for use: renal failure. P3 container cracked.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5014168
MDR Report Key1570788
Date Received2009-12-28
Date of Report2009-12-28
Date of Event2009-12-12
Date Added to Maude2010-01-08
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Reporter OccupationPHARMACIST
Health Professional3
Initial Report to FDA3
Report to FDA0
Event Location0
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NamePRISMASATE 500 CC DIALYSIS SOLUTION
Generic NameNONE
Product CodeFII
Date Received2009-12-28
Lot NumberP9H368
ID Number0733241403703
Device Expiration Date2010-08-30
Device AvailabilityN
Device Sequence No1
Device Event Key0
ManufacturerGAMBRO


Patients

Patient NumberTreatmentOutcomeDate
10 2009-12-28

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