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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

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SMITHS MEDICAL ASD, INC. LEVEL 1 HOTLINE FLUID WARMER; WARMER, THERMAL, INFUSION FLUID Back to Search Results
Model Number HL-90
Device Problem Device Alarm System (1012)
Patient Problem Insufficient Information (4580)
Event Date 01/01/2024
Event Type  malfunction  
Manufacturer Narrative
Date of event and operator of device are 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 "setting off the line insolation monitor." patient involvement is unknown.
 
Manufacturer Narrative
H3 and h6.Evaluation codes: updated.One device was received.Per visual inspection, cracked enclosure, stained water tank, water tank cover leak from reservoir, faded line cord.Outdated drain fitting, printed circuit board (pcb), and power switch.Functional testing could not duplicate or confirm the complaint.The product's history records were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.
 
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Brand Name
LEVEL 1 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 north
minneapolis, MN 55442
2247062300
MDR Report Key18763749
MDR Text Key336618730
Report Number3012307300-2024-00958
Device Sequence Number1
Product Code LGZ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K001764
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User Facility
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 04/02/2024
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 Other
Device Model NumberHL-90
Device Catalogue NumberCON-HL-90
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer02/06/2024
Initial Date Manufacturer Received 01/26/2024
Initial Date FDA Received02/22/2024
Supplement Dates Manufacturer Received03/04/2024
Supplement Dates FDA Received04/02/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/05/2010
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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