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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC LEVEL 1 HOTLINE LOW FLOW SYSTEM; WARMER, THERMAL, INFUSION FLUID

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SMITHS MEDICAL ASD, INC LEVEL 1 HOTLINE LOW FLOW SYSTEM; WARMER, THERMAL, INFUSION FLUID Back to Search Results
Model Number HL-390
Device Problem Electrical /Electronic Property Problem (1198)
Patient Problem No Information (3190)
Event Type  malfunction  
Manufacturer Narrative
Evaluation results: one level 1 hotline low flow system was returned for investigation in used condition.Visual inspection revealed a crack in the display.The customer reported product problem (display issue) was confirmed during testing.The product problem was attributed to the pcb component.User interface was identified as the root cause of the product problem.The faulty pcb was replaced as a result.Preventative maintenance was subsequently performed.The device then passed all the functional tests.
 
Event Description
It was reported that the fluid warmer had issues related to display.No patient injury or complications were reported in relation to this event.
 
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Brand Name
LEVEL 1 HOTLINE LOW FLOW SYSTEM
Type of Device
WARMER, THERMAL, INFUSION FLUID
Manufacturer (Section D)
SMITHS MEDICAL ASD, INC
6000 nathan lane north
minneapolis, mn
Manufacturer (Section G)
SMITHS MEDICAL ASD, INC
3350 granada avenue north
suite 100
oakdale, mn
Manufacturer Contact
dave halverson
6000 nathan lane north
minneapolis, mn 
MDR Report Key10026294
MDR Text Key189916236
Report Number3012307300-2020-03694
Device Sequence Number1
Product Code LGZ
Combination Product (y/n)N
Reporter Country CodeUS
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 05/05/2020
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 Model NumberHL-390
Device Catalogue NumberCON-HL-390
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/14/2020
Initial Date Manufacturer Received 04/07/2020
Initial Date FDA Received05/05/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/12/2019
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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