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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. LEVEL 1 FAST FLOW - TRAUMA FLUID AND BLOOD WARMER; WARMER, BLOOD, NON-ELECTROMAGNETIC RADIATION
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SMITHS MEDICAL ASD, INC. LEVEL 1 FAST FLOW - TRAUMA FLUID AND BLOOD WARMER; WARMER, BLOOD, NON-ELECTROMAGNETIC RADIATION Back to Search Results
Catalog Number 8002950
Device Problems Fluid/Blood Leak (1250); Insufficient Heating (1287)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/01/2024
Event Type  malfunction  
Event Description
It was reported that the device was not heating and leaking out the bottom during testing.There was no patient involvement and no harm/adverse event reported.
 
Manufacturer Narrative
B3.Date of event: 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.
 
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Brand Name
LEVEL 1 FAST FLOW - TRAUMA FLUID AND BLOOD WARMER
Type of Device
WARMER, BLOOD, NON-ELECTROMAGNETIC RADIATION
Manufacturer (Section D)
SMITHS MEDICAL ASD, INC.
6000 nathan ln n
minneapolis MN 55442
Manufacturer Contact
reed covert
6000 nathan lane n
minneapolis, MN 55442
2247062300
MDR Report Key18973101
MDR Text Key338560327
Report Number3012307300-2024-01655
Device Sequence Number1
Product Code BSB
UDI-Device Identifier50695085829506
UDI-Public(01)50695085829506(11)101203
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
BK020043
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 03/25/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/25/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number8002950
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/06/2024
Date Manufacturer Received02/28/2024
Was Device Evaluated by Manufacturer? No
Date Device Manufactured12/03/2010
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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