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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. CADD SET EXTENSION; SET, ADMINISTRATION, INTRAVASCULAR
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SMITHS MEDICAL ASD, INC. CADD SET EXTENSION; SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Lot Number 4271186
Device Problem Device Displays Incorrect Message (2591)
Patient Problem Insufficient Information (4580)
Event Date 08/10/2022
Event Type  malfunction  
Event Description
Unsolicited communication: pt reports she is creating a cassette in advance to change to later today but is getting a high-pressure alarm.Advised patient to use another tubing and prime again.Patient was successfully able to prime and saw (medication) drops at the end.Photographs were not provided.Set flow rate and volume delivered are unknown.Position of the pump when alarm occurred is unknown.This is a continuous infusion.Pump return tracking information is not available.No additional information is available at this time.Lot number: 4271186.Did the reported product fault occur while in use with the pt? no; did the product issue cause or contribute to pt or clinical injury? no; did the product issue cause or contribute to pt or clinical injury? no; is the actual device available for investigation? no; did we [mfr] replace the device? yes; 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; reported to (b)(6) by pt/caregiver.
 
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Brand Name
CADD SET EXTENSION
Type of Device
SET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
SMITHS MEDICAL ASD, INC.
minneapolis MN
MDR Report Key15233083
MDR Text Key298063169
Report NumberMW5111469
Device Sequence Number1
Product Code FPA
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 08/10/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/15/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Lot Number4271186
Is the Reporter a Health Professional? Yes
Patient Sequence Number1
Treatment
PUMP
Patient Age57 YR
Patient SexFemale
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