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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 Defective Device (2588)
Patient Problem Insufficient Information (4580)
Event Type  malfunction  
Event Description
Patients mother reported defective cassette, no further information provided.Unknown if patient missed a dose, unknown if any adverse events occurred, unknown if cassette available for return.Photographs were not provided, this is a continuous infusion, set flow rate and volume delivered are unknown, no additional information is available at this time.Did the reported product fault occur while in use with the patient? unknown.Did the product issue cause or contribute to patient or clinical injury? unknown.If yes was any medical intervention provided? unknown.Is the actual cassette available for investigation? unknown.Did we replace the cassette? unknown.Did the patient have additional cassettes they were able to switch to? unknown.If yes, was the patient able to successfully continue their infusion? unknown.If no, what was the patient instructed to do in able to continue their infusion? is the infusion life-sustaining? yes.What is the outcome of the event? unknown.Resolved? unknown.Ongoing? unknown.Reported to (b)(6) by: patient/caregiver.
 
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Brand Name
CASSETTE MEDI RESERVOIR
Type of Device
SET, I.V. FLUID TRANSFER
Manufacturer (Section D)
SMITHS MEDICAL ASD, INC.
MDR Report Key17031691
MDR Text Key316324892
Report NumberMW5117997
Device Sequence Number1
Product Code LHI
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 05/15/2023
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 Received05/30/2023
Patient Sequence Number1
Treatment
EPOPROSTENOL.
Patient SexFemale
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