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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. SMITHS MEDICAL LEVEL 1 HOTLINE LOW FLOW SYSTEMS; WARMER, BLOOD, NON-ELECTROMAGNETIC RADIATION
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SMITHS MEDICAL ASD, INC. SMITHS MEDICAL LEVEL 1 HOTLINE LOW FLOW SYSTEMS; WARMER, BLOOD, NON-ELECTROMAGNETIC RADIATION Back to Search Results
Catalog Number HL-90-UK-230
Device Problem Accessory Incompatible (1004)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/19/2019
Event Type  malfunction  
Event Description
Information was received that a smiths medical level 1 hotline low flow system is not accepting certain sets and is constantly alarming.Incident was reported to hace occurred while in use with a patient, and that no injury occurred.
 
Manufacturer Narrative
One fluid warmer was returned for evaluation.Visual inspection of the device found it to be in good physical condition.A dhr review was performed subsequent to the manufacturing of the device and prior to its release; no problems or issues were identified during this dhr review.Device tank was filled with water, and powered on.The device ran and heated as intended using several different temp checks as well as the customers disposables.The reported customer complaint was not confirmed.
 
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Brand Name
SMITHS MEDICAL LEVEL 1 HOTLINE LOW FLOW SYSTEMS
Type of Device
WARMER, BLOOD, NON-ELECTROMAGNETIC RADIATION
Manufacturer (Section D)
SMITHS MEDICAL ASD, INC.
6000 nathan lane n
minneapolis MN 55442
MDR Report Key9633808
MDR Text Key177373822
Report Number3012307300-2020-00608
Device Sequence Number1
Product Code BSB
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Type of Report Initial,Followup
Report Date 08/06/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/27/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Catalogue NumberHL-90-UK-230
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/10/2020
Date Manufacturer Received07/09/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
DISPOSABLE ADMINISTRATION SET
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