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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. CADD EXT SET; SET, ADMINISTRATION, INTRAVASCULAR
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SMITHS MEDICAL ASD, INC. CADD EXT SET; SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Device Problem Protective Measures Problem (3015)
Patient Problem Anxiety (2328)
Event Type  malfunction  
Event Description
Spontaneous communication: pt reports pump giving high pressure alarm while pt is trying to prime tubing.Pt was feeling anxious about possibly having to mix new cassette.While on the line, pt double checked and there were no kinks in her tubing, nothing was clamped.Switching pump resulted in same error.Advised patient to change tubing which she did while on the line.Changing tubing resolved alarm.Pt was connecting and beginning infusion at end of call.No further questions at this time.Pump serial numbers not provided.Issue resolved, no replacement needed.No further information known.All known information is contained on this form.If any additional information is received it will be provided on a separate report.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.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? no; is the actual device available for investigation? yes; did we [mfr] replace the device? no; did the pt have a backup device they were able to switch to? 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 EXT SET
Type of Device
SET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
SMITHS MEDICAL ASD, INC.
MDR Report Key14623049
MDR Text Key293694017
Report NumberMW5110144
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 06/01/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/06/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Is the Reporter a Health Professional? Yes
Patient Sequence Number1
Patient SexFemale
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