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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 DISPOSABLE; TUBING, FLUID DELIVERY
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SMITHS MEDICAL ASD, INC. SMITHS MEDICAL LEVEL 1 HOTLINE DISPOSABLE; TUBING, FLUID DELIVERY Back to Search Results
Lot Number 3772162
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 tubing set not being accepted by fluid warmer.Incident was reported to have occurred while in use with a patient, and that no injury occurred.
 
Manufacturer Narrative
Other, other text: device evaluation: picture of level 1 hotline low flow system was returned for analysis.Investigation performed and no discrepancies could be observed in the pictures.The customer reported problem could not be confirmed.No root cause has to be confirmed since the complaint was not confirmed.No corrective actions are required since the complaint was not confirmed.
 
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Brand Name
SMITHS MEDICAL LEVEL 1 HOTLINE DISPOSABLE
Type of Device
TUBING, FLUID DELIVERY
Manufacturer (Section D)
SMITHS MEDICAL ASD, INC.
6000 nathan lane n
minneapolis MN 55442
MDR Report Key9639555
MDR Text Key177370648
Report Number3012307300-2020-00815
Device Sequence Number1
Product Code FPK
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 11/26/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/28/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Lot Number3772162
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/15/2020
Was the Report Sent to FDA? No
Date Manufacturer Received10/26/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
SMITHS MEDICAL HOTLINE FLUID WARMER
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