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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 Pumping Stopped (1503)
Patient Problem Skin Inflammation/ Irritation (4545)
Event Type  Injury  
Event Description
Patient reports she was hospitalized on (b)(6) 2022 for line replacement she was having irritation at the central line site that md replaced some stitches at on (b)(6) 2022.She was told it did not need to be replaced unless she saw the white cuff area of the line.On (b)(6) 2022, patient states she noticed the white cuff of the line and headed to the hospital where the line was replaced.She also reports that both pumps sn (b)(4) and sn (b)(4) will randomly error with no disposable pump won't run.Patient states she is able to clear this error by adjusting the cassette tubing, so the medication infuses.She did not have any cassette lot numbers.Did the reported product fault occur while in use with the patient? yes; did the product issue cause or contribute to patient or clinical injury? no.Is the actual device available for investigation? no.Did the pt have a backup device they were able to switch to? yes; if yes, was the pt able to successfully continue their infusion? yes; is the infusion life-sustaining? yes; what is the outcome of the event? resolved.Reported to (b)(6) 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 Key13500319
MDR Text Key285420319
Report NumberMW5107332
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 02/04/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/08/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Is the Reporter a Health Professional? Yes
Patient Sequence Number1
Treatment
CADD PUMP
Patient Outcome(s) Hospitalization;
Patient SexFemale
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