ICED THERMOSET INJECTATE DELIVERY SYSTEM 41423-03

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-05-07 for ICED THERMOSET INJECTATE DELIVERY SYSTEM 41423-03 manufactured by Icu Medical.

Event Text Entries

[107822423] A (b)(6) year old male patient underwent five vessel coronary artery bypass graft surgery. During procedure, the cardiac output device gave wrong reading. Upon inspection, it was noted that the tubing from the iced thermoset delivery system would not connect properly and leak out. The leak occurred from the male end of the tubing.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5077042
MDR Report Key7493956
Date Received2018-05-07
Date of Report2018-05-03
Date of Event2018-04-18
Date Added to Maude2018-05-08
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
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
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameICED THERMOSET INJECTATE DELIVERY SYSTEM
Generic NameFLOWDIRECTED INFUSION
Product CodeKRB
Date Received2018-05-07
Model Number41423-03
Lot Number3598129
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Eval'ed by MfgrI
Device Sequence No1
Device Event Key0
ManufacturerICU MEDICAL
Manufacturer AddressSAN CLEMENTE CA 92673 US 92673


Patients

Patient NumberTreatmentOutcomeDate
10 2018-05-07

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