PRISMAFLEX 115269

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-03-27 for PRISMAFLEX 115269 manufactured by Baxter Healthcare Corporation.

Event Text Entries

[185248647] Should additional relevant information become available, a supplemental report will be submitted.
Patient Sequence No: 1, Text Type: N, H10


[185248648] It was reported that during continuous renal replacement therapy, a patient passed away while connected to a prismaflex control unit. The cause of death was not reported. It was not reported if an autopsy was performed. No additional information is available.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number9616026-2020-00012
MDR Report Key9889236
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2020-03-27
Date of Report2020-03-27
Date of Event2020-03-04
Date Mfgr Received2020-03-04
Date Added to Maude2020-03-27
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag0
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer Street25212 W. ILLINOIS ROUTE 120
Manufacturer CityROUND LAKE IL 60073
Manufacturer CountryUS
Manufacturer Postal60073
Manufacturer Phone2242702068
Manufacturer G1BAXTER HEALTHCARE - LUND MONITORS
Manufacturer StreetMAGISTRATSVAGEN 16
Manufacturer CityLUND SKANE LAN SE-22643
Manufacturer CountrySW
Manufacturer Postal CodeSE-22643
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 CodeKDI
Date Received2020-03-27
Model NumberNA
Catalog Number115269
OperatorHEALTH PROFESSIONAL
Device Availability*
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerBAXTER HEALTHCARE CORPORATION
Manufacturer AddressDEERFIELD IL


Patients

Patient NumberTreatmentOutcomeDate
101. Death 2020-03-27

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.