LEVEL 1 TRAUMA FAST FLOW DISPOSABLES DI-100

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-02-12 for LEVEL 1 TRAUMA FAST FLOW DISPOSABLES DI-100 manufactured by Smiths Medical Asd; Inc..

Event Text Entries

[179232715] Information was received indicating that a smiths medical level 1? Disposable liquid was observed to be dripping out above the drip chamber following adding pressure to the pressure chamber. The disposable was then reported to be changed out three times, but this situation was reported to occur each time. During this time, the patient was reported to be requiring resuscitation with other medication and therapy given. Unfortunately, the patient expired. The hospital reported "the death had nothing to do with the faulty systems. " the disposables were disposed of with no further information.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3012307300-2020-00989
MDR Report Key9702153
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2020-02-12
Date of Report2020-02-21
Date of Event2020-01-13
Date Mfgr Received2020-01-14
Device Manufacturer Date2011-07-01
Date Added to Maude2020-02-12
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 N
Manufacturer CityMINNEAPOLIS, MN 55442
Manufacturer CountryUS
Manufacturer Postal55442
Manufacturer Phone7633833310
Manufacturer G1SMITHS MEDICAL ASD; INC.
Manufacturer Street6000 NATHAN LANE N
Manufacturer CityMINNEAPOLIS, MN 55442
Manufacturer CountryUS
Manufacturer Postal Code55442
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameLEVEL 1 TRAUMA FAST FLOW DISPOSABLES
Generic NameDEVICE, WARMING. BLOOD AND PLASMA
Product CodeKZL
Date Received2020-02-12
Model NumberDI-100
Catalog NumberDI-100
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerSMITHS MEDICAL ASD; INC.
Manufacturer Address6000 NATHAN LANE N MINNEAPOLIS, MN 55442 US 55442


Patients

Patient NumberTreatmentOutcomeDate
10 2020-02-12

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