Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
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, PRODUCT CODE: LGZ
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

SMITHS MEDICAL ASD, INC. LEVEL 1 HOTLINE BLOOD AND FLUID WARMER; WARMER, THERMAL, INFUSION FLUID, PRODUCT CODE: LGZ Back to Search Results
Catalog Number CON-HL-90
Device Problem Leak/Splash (1354)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Event Description
Information was received that a smiths medical level 1 hotline blood and fluid warmer had a "leaking from front cover".No adverse effects were reported.
 
Manufacturer Narrative
One fluid warmer was returned for evaluation.Visual inspection of the device found it to be in fair condition.Device underwent functional testing by filling tank with water and performed power up of the device.As a result, it was noted to be leaking through the enclosure, confirming the reported customer complaint.The problem source was determined to be disconnection of the hose causing the water to leak.This investigation revealed no intrinsic evidence to suggest a cause of issue related to manufacturing.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
LEVEL 1 HOTLINE BLOOD AND FLUID WARMER
Type of Device
WARMER, THERMAL, INFUSION FLUID, PRODUCT CODE: LGZ
Manufacturer (Section D)
SMITHS MEDICAL ASD, INC.
6000 nathan lane north
minneapolis MN 55442
MDR Report Key9099954
MDR Text Key159621300
Report Number3012307300-2019-02138
Device Sequence Number1
Product Code LGZ
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 09/19/2019
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 No Information
Device Catalogue NumberCON-HL-90
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/09/2019
Initial Date Manufacturer Received 08/22/2019
Initial Date FDA Received09/20/2019
Supplement Dates Manufacturer Received08/22/2019
Supplement Dates FDA Received09/20/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
-
-