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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL ASD; INC. LEVEL 1 TRAUMA FAST FLOW DISPOSABLE; WARMER, THERMAL, INFUSION FLUID
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SMITHS MEDICAL ASD; INC. LEVEL 1 TRAUMA FAST FLOW DISPOSABLE; WARMER, THERMAL, INFUSION FLUID Back to Search Results
Catalog Number DI-50
Device Problems Failure to Infuse (2340); No Flow (2991)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/12/2019
Event Type  malfunction  
Event Description
Information was received indicating that during an emergent case for ruptured femoral artery, a smiths medical level 1 trauma fast flow disposable would not deliver warm fluid and blood.The unit was changed out and the patient recovered.There were no reported adverse effects.
 
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Brand Name
LEVEL 1 TRAUMA FAST FLOW DISPOSABLE
Type of Device
WARMER, THERMAL, INFUSION FLUID
Manufacturer (Section D)
SMITHS MEDICAL ASD; INC.
6000 nathan lane n
minneapolis, MN 55442
Manufacturer (Section G)
SMITHS MEDICAL ASD; INC.
6000 nathan lane n
minneapolis, MN 55442
Manufacturer Contact
dave halverson
6000 nathan lane n
minneapolis,, MN 55442
7633833310
MDR Report Key9598376
MDR Text Key177424298
Report Number3012307300-2020-00594
Device Sequence Number1
Product Code LGZ
Combination Product (y/n)N
Reporter Country CodeSZ
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,user facility
Reporter Occupation Other
Type of Report Initial
Report Date 01/16/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/16/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date01/23/2022
Device Catalogue NumberDI-50
Device Lot Number3568572
Was Device Available for Evaluation? No
Date Manufacturer Received12/13/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/08/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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