PRISMAFLEX TPE 115314

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2019-05-09 for PRISMAFLEX TPE 115314 manufactured by Baxter Healthcare - Meyzieu.

Event Text Entries

[145654351] Facility name: (b)(6). Should additional relevant information become available, a supplemental report will be submitted.
Patient Sequence No: 1, Text Type: N, H10


[145654352] It was reported that during treatment with a prismaflex tpe1000 set, an internal blood leakage was observed. It was reported "reddish effluent fluid/bag was found by naked eyes". There was no patient injury or medical intervention associated with this event. No additional information is available.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number8010182-2019-00118
MDR Report Key8596742
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2019-05-09
Date of Report2019-06-10
Date of Event2019-04-08
Date Mfgr Received2019-06-04
Device Manufacturer Date2018-01-01
Date Added to Maude2019-05-09
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
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 - MEYZIEU
Manufacturer Street7, AV LIONEL TERRAY, B.P. 126
Manufacturer CityMEYZIEU 69883
Manufacturer CountryFR
Manufacturer Postal Code69883
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NamePRISMAFLEX TPE
Generic NameSEPARATOR FOR THERAPEUTIC PURPOSES, MEMBRANE AUTOMATED BLOOD CELL/PLASMA
Product CodeMDP
Date Received2019-05-09
Model NumberNA
Catalog Number115314
Lot Number18A1102A
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerBAXTER HEALTHCARE - MEYZIEU
Manufacturer AddressMEYZIEU


Patients

Patient NumberTreatmentOutcomeDate
10 2019-05-09

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