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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC., HOTLINE BLOOD AND FLUID WARMER; LGZ - WARMER, THERMAL, INFUSION FLUID

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SMITHS MEDICAL ASD, INC., HOTLINE BLOOD AND FLUID WARMER; LGZ - WARMER, THERMAL, INFUSION FLUID Back to Search Results
Catalog Number HL-90
Device Problem Fluid/Blood Leak (1250)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Event Description
(b)(4).
 
Manufacturer Narrative
Customer has not yet returned the device to the manufacturer for device evaluation.When and if the device becomes available and is returned and evaluated the manufacturer will file a follow-up report detailing the results of the evaluation.
 
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Brand Name
HOTLINE BLOOD AND FLUID WARMER
Type of Device
LGZ - WARMER, THERMAL, INFUSION FLUID
Manufacturer (Section D)
SMITHS MEDICAL ASD, INC.,
rockland MA
Manufacturer (Section G)
SMITHS MEDICAL ASD,INC.,
160 weymouth st.
rockland MA 02370
Manufacturer Contact
michele seliga
1265 grey fox rd.
st. paul, MN 55112
6516287604
MDR Report Key4736771
MDR Text Key5823756
Report Number2183502-2015-00276
Device Sequence Number1
Product Code LGZ
Combination Product (y/n)N
PMA/PMN Number
K911383
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,User Facility
Type of Report Initial
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 Health Professional
Device Catalogue NumberHL-90
Was Device Available for Evaluation? No
Device Age4 YR
Initial Date Manufacturer Received 04/03/2015
Initial Date FDA Received04/23/2015
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/21/2010
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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