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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, 390; WARMER, THERMAL, INFUSION FLUID

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SMITHS MEDICAL ASD, INC. LEVEL 1 HOTLINE FLUID WARMER, 390; WARMER, THERMAL, INFUSION FLUID Back to Search Results
Model Number HL-390
Device Problems Defective Alarm (1014); Display or Visual Feedback Problem (1184)
Patient Problem Insufficient Information (4580)
Event Date 12/01/2023
Event Type  malfunction  
Manufacturer Narrative
B3: date of event is unknown.H3 other: device has not been returned 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 the device continues to alarm and does not stop.Also, led light is missing.Patient involvement is unknown.
 
Manufacturer Narrative
D9: date returned to mfg.: 12/4/2023.H3.Device evaluated by manufacturer and h6.Evaluation codes: updated.Device evaluation: one device was received.Per visual inspection, cracked enclosure and tank cover.Damaged printed circuit board (pcb) and front cover.Corroded drain fitting and faded line cord.Per functional testing, as soon as the device is powered on it starts alarming confirming the complaint.The root cause was a damaged micro switch.It was unknown what caused the damage.The product's history records were reviewed and there were no non-conformances nor service-related issues that would have resulted in the reported complaint.No action taken due to the condition of the device.It was deemed beyond economical repair and was scrapped.A2, a3, a4, a5, a6, b6, b7, and d10: corrected.
 
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Brand Name
LEVEL 1 HOTLINE FLUID WARMER, 390
Type of Device
WARMER, THERMAL, INFUSION FLUID
Manufacturer (Section D)
SMITHS MEDICAL ASD, INC.
3350 granada ave n, suite 100
oakdale MN 55128
Manufacturer Contact
reed covert
6000 nathan lane north
minneapolis, MN 55442
2247062300
MDR Report Key18307370
MDR Text Key330228711
Report Number2183161-2023-00006
Device Sequence Number1
Product Code LGZ
UDI-Device Identifier10695085002796
UDI-Public10695085002796
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 03/04/2024
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-390
Device Catalogue NumberCON-HL-390
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 11/17/2023
Initial Date FDA Received12/11/2023
Supplement Dates Manufacturer Received02/05/2024
Supplement Dates FDA Received03/04/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/17/2016
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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