CT 5M1546

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2011-06-22 for CT 5M1546 manufactured by Nipro Corporation *usd*.

Event Text Entries

[2071679] A customer called baxter to report a blood leak. The leak was at the beginning of treatment. The patient continued therapy with a different dialyzer, the patient went back on with a backup ct190g dialyzer and was okay. There was no patient injury and no medical intervention reported, the patient is doing fine.
Patient Sequence No: 1, Text Type: D, B5


[9170390] (b)(4). The sample was discarded. This mdr is being submitted as part of baxter renal's retrospective review & remediation project. This report is being filed late to fulfill baxter's commitment to perform a two year retrospective review of renal complaints in response to fda-warning letter chi-07-10.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number1423500-2011-08184
MDR Report Key2137240
Report Source05
Date Received2011-06-22
Date of Report2009-03-20
Date of Event2009-02-16
Date Mfgr Received2009-03-20
Date Added to Maude2012-02-10
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 FDA0
Event Location0
Manufacturer ContactKAREN KIRBY
Manufacturer Street25212 W. ILLINOIS ROUTE 120
Manufacturer CityROUND LAKE IL 60073
Manufacturer CountryUS
Manufacturer Postal60073
Manufacturer Phone8472704541
Manufacturer G1NIPRO CORPORATION *USD*
Manufacturer Street8-7 HANUKI-YACHI, NIIDA-AZA
Manufacturer CityOHDATE-SHI
Manufacturer CountryJA
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameCT
Generic NameHEMODIALYZER, RE-USE, HIGH FLUX
Product CodeMSF
Date Received2011-06-22
Catalog Number5M1546
Lot Number08C10EX
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerNIPRO CORPORATION *USD*
Manufacturer Address8-7 HANUKI-YACHI, NIIDA-AZA OHDATE-SHI JA


Patients

Patient NumberTreatmentOutcomeDate
10 2011-06-22

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