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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
Model Number 21-7106-24
Device Problems Leak/Splash (1354); Tear, Rip or Hole in Device Packaging (2385)
Patient Problems Low Blood Pressure/ Hypotension (1914); Skin Discoloration (2074)
Event Type  Injury  
Event Description
Patient reporting cadd extension line was found to be leaking overnight while he slept.He did not witness any kinks, the leak was coming from a hole that is typically for air per pt.Pt found he had low blood pressure, heart rate in the 60's, and was pale.At that time he did his new mill and changed his set completely, including the pump.The issue subsequently resolved.Advised that if the issue happens when changing back to that pump, call us right away for replacement.Unknown if md aware.No other information known.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 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; 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 EXT SET
Type of Device
SET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
SMITHS MEDICAL ASD, INC.
MDR Report Key15028840
MDR Text Key296091712
Report NumberMW5110898
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 07/13/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/14/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Model Number21-7106-24
Is the Reporter a Health Professional? Yes
Patient Sequence Number1
Patient SexMale
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