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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL, ASD, INC. LEVEL 1® HOTLINE® BLOOD AND FLUID WARMER; WARMER, THERMAL, INFUSION FLUID

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SMITHS MEDICAL, ASD, INC. LEVEL 1® HOTLINE® BLOOD AND FLUID WARMER; WARMER, THERMAL, INFUSION FLUID Back to Search Results
Model Number HL-10
Device Problem Defective Alarm (1014)
Patient Problem No Patient Involvement (2645)
Event Date 10/25/2017
Event Type  malfunction  
Event Description
It was reported that none of the alarms worked on a level 1® hotline® blood and fluid warmer.The customer states that this was an out of the box failure.After setting up the device and letting it run for a half hour, none of the alarms worked after performing all alarm tests.There was no patient involvement.
 
Manufacturer Narrative
A level 1® hotline® blood and fluid warmer was returned in new condition.Pressed alarm test button and no visual or audible alarm was initiated.Removed front cover for further inspection.Found ribbon cable for alarm test membrane switch disconnected from circuit board input.Based on the evidence, the complaint was confirmed.The root cause for this issue is related to a manufacturing process.
 
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Brand Name
LEVEL 1® HOTLINE® BLOOD AND FLUID WARMER
Type of Device
WARMER, THERMAL, INFUSION FLUID
Manufacturer (Section D)
SMITHS MEDICAL, ASD, INC.
6000 nathan lane north
minneapolis MN 55442
Manufacturer (Section G)
SMITHS MEDICAL ASD, INC.
1265 gray fox road
st. paul MN 55112
Manufacturer Contact
dave halverson
6000 nathane lane north
plymouth, MN 55442
7633833310
MDR Report Key7005801
MDR Text Key91539558
Report Number3012307300-2017-02385
Device Sequence Number1
Product Code LGZ
UDI-Device Identifier50695085820909
UDI-Public50695085820909
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 Biomedical Engineer
Type of Report Initial,Followup
Report Date 12/08/2017
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 Health Professional
Device Model NumberHL-10
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/02/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 10/25/2017
Initial Date FDA Received11/07/2017
Supplement Dates Manufacturer Received11/15/2017
Supplement Dates FDA Received12/08/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/10/2017
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
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