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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. CASSETTE MEDI RESERVOIR; SET, I.V. FLUID TRANSFER
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SMITHS MEDICAL ASD, INC. CASSETTE MEDI RESERVOIR; SET, I.V. FLUID TRANSFER Back to Search Results
Device Problem Protective Measures Problem (3015)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Event Description
Pt reports that they had "no disposable" alarm and switched cassettes and alarm was still running.Pt changed pumps and was able to continue infusion.Pt reports that they used this pump today, al day, with no issues.Pt thinks this might be a cassettes issue, but confirmed that their other pump is working with no issue.Cassette lot number unknown.Pump serial number: (b)(4).No additional info, details, or dates available.Pump return tracking information is not available.Photographs were not provided.This is a continuous infusion.Set flow rate and volume delivered are unknown.Position of the pump when alarm occurred is unknown.The reported product fault did occur while in use with a pt.The product issue did not cause or contribute to pt or clinical injury.The actual device is available to be returned for investigation.The device is being replaced.The pt did have a backup device they were able to switch to.The pt was able to successfully continue their infusion.The infusion is life-sustaining.The event is resolved.Reported to (b)(6) by pt/caregiver.Reference report mw5115318.
 
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Brand Name
CASSETTE MEDI RESERVOIR
Type of Device
SET, I.V. FLUID TRANSFER
Manufacturer (Section D)
SMITHS MEDICAL ASD, INC.
minneapolis MN
MDR Report Key16460142
MDR Text Key310546061
Report NumberMW5115319
Device Sequence Number1
Product Code LHI
Combination Product (y/n)Y
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 02/25/2023
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
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received02/28/2023
Patient Sequence Number1
Patient SexFemale
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