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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. CASSETTE MEDICATION RESERVOIR; SET, I.V. FLUID TRANSFER
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SMITHS MEDICAL ASD, INC. CASSETTE MEDICATION RESERVOIR; SET, I.V. FLUID TRANSFER Back to Search Results
Lot Number 4329614
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Respiratory Insufficiency (4462)
Event Type  Injury  
Event Description
Patient's mom reports patient has impacted cassette lot: 4329614, expiration date unknown.Mom reported patient is having shortness of breath and experiencing red cheeks and no cassette errors.Patient is currently on a mountain on high altitude and they are several hours away from home.Unknown if side effects are due to high attitude or caused by cassette issue.Unknown lot number of the cassette that patient is using at the time side effects were reported.Dose or amount: treprostinil 121 ng/kg/min.Pump return tracking information is not applicable to event photographs were not provided.This is a continuous infusion.Set flow rate and volume delivered are unknown.Position of pump when alarm occurred is not applicable.No additional information is available at this time.Did the product issue cause or contribute to pt or clinical injury? potentially; if yes, was any medical intervention provided? no; is the actual product available for investigation? no.Reported to cvs/caremark by pt/caregiver.
 
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Brand Name
CASSETTE MEDICATION RESERVOIR
Type of Device
SET, I.V. FLUID TRANSFER
Manufacturer (Section D)
SMITHS MEDICAL ASD, INC.
MDR Report Key16043477
MDR Text Key306271364
Report NumberMW5113983
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 12/15/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/22/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Lot Number4329614
Is the Reporter a Health Professional? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
PUMP; TREPROSTINIL ; TUBING
Patient SexMale
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