PORTEX SODASORB CO2 ABSORBENT 008870

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-04-10 for PORTEX SODASORB CO2 ABSORBENT 008870 manufactured by Smiths Medical Asd, Inc..

Event Text Entries

[141478993] Information was received that a smiths medical portex sodasorb co2 absorbent was broken, which generated an "error" alarm on the machie. Event occured prior to use with a patient. No adverse effects were reported.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3012307300-2019-01910
MDR Report Key8499879
Date Received2019-04-10
Date of Report2019-04-10
Date Mfgr Received2019-03-13
Date Added to Maude2019-04-10
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 FDA3
Event Location3
Manufacturer ContactDAVE HALVERSON
Manufacturer Street6000 NATHAN LANE NORTH
Manufacturer CityMINNEAPOLIS MN 55442
Manufacturer CountryUS
Manufacturer Postal55442
Manufacturer G1SMITHS MEDICAL INTERNATIONAL LTD
Manufacturer StreetBOUNDARY ROAD
Manufacturer CityHYTHE, KENT
Manufacturer CountryUK
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NamePORTEX SODASORB CO2 ABSORBENT
Generic NameABSORBER, CARBON-DIOXIDE PRODUCT CODE: BSF
Product CodeBSF
Date Received2019-04-10
Returned To Mfg2019-04-08
Catalog Number008870
Device AvailabilityR
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerSMITHS MEDICAL ASD, INC.
Manufacturer Address6000 NATHAN LANE NORTH MINNEAPOLIS MN 55442 US 55442


Patients

Patient NumberTreatmentOutcomeDate
10 2019-04-10

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