PRESSURE BAG

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-03-12 for PRESSURE BAG manufactured by Carefusion 303, Inc..

Event Text Entries

[138663484] Patient went to mri with aline infusing with pressure bag. Aline did not have transducer attached due to it being mri incompatible per mri tech. Rn noticed that the entire bag of fluid had infused into patient during procedure.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number8416141
MDR Report Key8416141
Date Received2019-03-12
Date of Report2019-02-27
Date of Event2019-02-26
Report Date2019-02-12
Date Reported to FDA2019-02-12
Date Reported to Mfgr2019-03-13
Date Added to Maude2019-03-13
Event Key0
Report Source CodeUser Facility report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag0
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationRISK MANAGER
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NamePRESSURE BAG
Generic NameINFUSOR, PRESSURE, FOR I.V. BAGS
Product CodeKZD
Date Received2019-03-12
Device Availability*
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerCAREFUSION 303, INC.
Manufacturer Address10020 PACIFIC MESA BLVD. SAN DIEGO CA 92121 US 92121


Patients

Patient NumberTreatmentOutcomeDate
10 2019-03-12

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