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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
Lot Number 4329617
Device Problem Nonstandard Device (1420)
Patient Problems Dyspnea (1816); Low Oxygen Saturation (2477)
Event Type  Injury  
Event Description
Patient reports she has 4 cassettes from lot 4329617, expiration date unknown, which are affected by the medical device correction.Patient reports she has been getting "no disposable attached" alarms and for the past two days increased shortness of breath and lower oxygen levels (ongoing).Patient was advised to mix a new cassette using unaffected cassettes.Requested practice liaison notify md office to see if further action is required.No other information available.Iv remodulin patient.Pump return tracking information is not applicable.Photographs were not provided.This is a continuous infusion.Set flow rate and volume delivered are unknown.Position of pump when alarm occurred is unknown.No additional information is available at this time.Did the reported product fault occur while in use with the pt? yes; did the product issue cause or contribute to pt or clinical injury? yes; if yes, was any medical intervention provided? no; is the actual product available for investigation? yes.Reported to cvs/caremark by pt/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 Key16043432
MDR Text Key306217349
Report NumberMW5113976
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 12/16/2022
4 Devices were Involved in the Event: 1   2   3   4  
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 Operator Lay User/Patient
Device Lot Number4329617
Is the Reporter a Health Professional? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
REMODULIN
Patient SexFemale
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