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

[2071209] This complaint originated as a result of the baxter renal clinical helpline medical information specialist calling corporate product surveillance (b)(4) 2009 to relay a report from a customer, received by voice mail the same day for one (1) ct-190g cellulose triacetate , product code 5m1546, lot number unknown, of which customer caller stated she had questions about a ct-190 dialyzer concerning a patient incident today ((b)(6) 2009). No further information is available at this time. On (b)(6) 2009, product surveillance spoke to the nurse about this incident. She stated that this was not a complaint against the dialyzer, there were no problems with the dialyzer. She had a question regarding the incorrect setup of the dialyzer and bloodline when she spoke to the baxter renal clinical helpline medical information specialist (mis). She stated that the incorrect setup of the bloodline to the dialyzer was a human error by the technician. The technician had attached the arterial bloodline to the venous port on the dialyzer with the patient hooked up. The therapy was run for an hour in this setup with the patient. The charge nurse then noticed that the setup was incorrect, stopped the therapy, reversed the bloodline, connected it properly and resumed therapy with the patient. The patient continued therapy with no problems. There was no patient injury or medical intervention reported with this incident. The patient is okay. There is no problem with the dialyzer.
Patient Sequence No: 1, Text Type: D, B5


[9155168] (b)(4). This incident was determined to be caused by use/user error and there was no allegation of a product malfunction. Therefore a batch review and sample evaluation will not be conducted. 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 Number1423500-2011-08178
MDR Report Key2137217
Report Source05
Date Received2011-06-22
Date of Report2009-06-10
Date of Event2009-06-10
Date Mfgr Received2009-06-10
Date Added to Maude2012-02-13
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 ContactVIRGINIA MCKINNEY
Manufacturer Street25212 W. ILLINOIS ROUTE 120
Manufacturer CityROUND LAKE IL 60073
Manufacturer CountryUS
Manufacturer Postal60073
Manufacturer Phone8472702835
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
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

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