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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
Catalog Number HL-90
Device Problems Break (1069); Fluid/Blood Leak (1250); Power Problem (3010)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/23/2023
Event Type  malfunction  
Manufacturer Narrative
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 there was a leak from the container and in the fluid tubing connector.Broken power cord.There was no patient involvement and no patient harm/adverse event reported.
 
Manufacturer Narrative
One device was received for investigation.The reported issue was confirmed during visual inspection, which identified that the case assembly was cracked and the power cable was damaged.The investigation did not identify a root cause for the observed condition.The case assembly, power cable, float switch, and o-rings were replaced and the device passed inspection.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.
 
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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.
3350 granada ave n, suite 100
oakdale MN 55128
Manufacturer Contact
reed covert
6000 nathan lane north
minneapolis, MN 55442
2247062300
MDR Report Key18384496
MDR Text Key331228103
Report Number2183161-2023-00044
Device Sequence Number1
Product Code LGZ
UDI-Device Identifier50695085820909
UDI-Public50695085820909
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
K911383
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 02/02/2024
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 Catalogue NumberHL-90
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/11/2023
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 11/27/2023
Initial Date FDA Received12/22/2023
Supplement Dates Manufacturer Received01/04/2024
Supplement Dates FDA Received02/02/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/18/2008
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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