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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. LEVEL 1 LOW FLOW - HOTLINE FLUID WARMER; WARMER, THERMAL, INFUSION FLUID
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SMITHS MEDICAL ASD, INC. LEVEL 1 LOW FLOW - HOTLINE FLUID WARMER; WARMER, THERMAL, INFUSION FLUID Back to Search Results
Catalog Number HL-390
Device Problem Contamination (1120)
Patient Problem Insufficient Information (4580)
Event Date 02/01/2024
Event Type  malfunction  
Manufacturer Narrative
Date of event: unknown.No information has been provided to date.Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.
 
Event Description
It was reported that internal contamination was found in the device.There was unknown patient involvement and unknown patient harm/adverse event reported.
 
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Brand Name
LEVEL 1 LOW FLOW - HOTLINE FLUID WARMER
Type of Device
WARMER, THERMAL, INFUSION FLUID
Manufacturer (Section D)
SMITHS MEDICAL ASD, INC.
6000 nathan ln n
minneapolis MN 55442
Manufacturer Contact
reed covert
6000 nathan lane n
minneapolis, MN 55442
2247062300
MDR Report Key18861404
MDR Text Key337322739
Report Number3012307300-2024-01209
Device Sequence Number1
Product Code LGZ
UDI-Device Identifier10695085002796
UDI-Public(01)10695085002796(11)180109
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K911383
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User Facility
Reporter Occupation Other
Type of Report Initial
Report Date 03/07/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/07/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue NumberHL-390
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/22/2024
Date Manufacturer Received02/11/2024
Was Device Evaluated by Manufacturer? No
Date Device Manufactured01/09/2018
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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