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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. LEVEL 1 FAST FLOW FLUID WARMER; WARMER, BLOOD, NON-ELECTROMAGNETIC RADIATION
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SMITHS MEDICAL ASD, INC. LEVEL 1 FAST FLOW FLUID WARMER; WARMER, BLOOD, NON-ELECTROMAGNETIC RADIATION Back to Search Results
Catalog Number 8002950
Device Problems Fluid/Blood Leak (1250); No Flow (2991); Temperature Problem (3022)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/15/2023
Event Type  malfunction  
Manufacturer Narrative
D5.Other operator of device: operator of device is unknown.H3.Reason device not evaluated by mfg: other; device was not returned to manufacturer.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 rapid infuser gave a temperature alarm error, wasn't circulating water, and leaked.There was no patient involvement and no patient harm/adverse event reported.
 
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Brand Name
LEVEL 1 FAST FLOW FLUID 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 Key18837262
MDR Text Key336896912
Report Number3012307300-2024-01145
Device Sequence Number1
Product Code BSB
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 03/05/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/05/2024
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? Yes
Date Manufacturer Received02/06/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/07/2020
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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