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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. LEVEL 1 HOTLINE FLUID WARMER; WARMER, THERMAL, INFUSION FLUID, PRODUCT CODE: LGZ
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SMITHS MEDICAL ASD, INC. LEVEL 1 HOTLINE FLUID WARMER; WARMER, THERMAL, INFUSION FLUID, PRODUCT CODE: LGZ Back to Search Results
Catalog Number CON-HL-390
Device Problem Leak/Splash (1354)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Event Description
Information was received that a smiths medical level 1 hotline fluid warmer was "leaking".No adverse effects were reported.
 
Manufacturer Narrative
One fluid warmer was received for evaluation.Visual inspection of the device found it to be in poor condition, as it leaks water from a crack by the drain elbow.The device tank was filled with water and it immediately began leaking from a crack in the enclosure by the drain elbow.This confirms the reported customer complaint, with a problem source that was determined to be normal wear and tear of the device.No parts will be replaced as the device will be scrapped.While no definitive problem source to the reported issue could be determined, this investigation revealed no intrinsic evidence to suggest a cause of issue related to manufacturing.
 
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Brand Name
LEVEL 1 HOTLINE FLUID WARMER
Type of Device
WARMER, THERMAL, INFUSION FLUID, PRODUCT CODE: LGZ
Manufacturer (Section D)
SMITHS MEDICAL ASD, INC.
6000 nathan lane north
minneapolis MN 55442
MDR Report Key9196677
MDR Text Key162539419
Report Number3012307300-2019-01722
Device Sequence Number1
Product Code LGZ
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Type of Report Initial,Followup
Report Date 10/15/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Catalogue NumberCON-HL-390
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/15/2019
Initial Date Manufacturer Received 09/16/2019
Initial Date FDA Received10/16/2019
Supplement Dates Manufacturer Received09/16/2019
Supplement Dates FDA Received10/16/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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