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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL SMITHS MEDICAL ASD, INC. CADD EXTENSION SET; SET, ADMINISTRATION, INTRAVASCULAR
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SMITHS MEDICAL SMITHS MEDICAL ASD, INC. CADD EXTENSION SET; SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Device Problem Fluid/Blood Leak (1250)
Patient Problems Dizziness (2194); Underdose (2542)
Event Type  Injury  
Event Description
Patient reported remodulin tubing leaks at filter site; okay to prime but leaks after 1 to 2 days.This has happened a couple of times.Once during the night, noticed clothes wet, and had symptoms of lightheadedness from remodulin not running at full dose.Patient does not have lot number of defective tubing on hand, but will call pharmacy back later with this.Patient has tubing available for return.No further information available.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? yes.Did we [mfr] replace device? no, patient had more on hand.Did the patient have a backup device they were able to switch to? yes, able to continue infusion.If yes, was the patient 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: patient/caregiver.
 
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Brand Name
CADD EXTENSION SET
Type of Device
SET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
SMITHS MEDICAL SMITHS MEDICAL ASD, INC.
st. paul MN
MDR Report Key11313386
MDR Text Key231584625
Report NumberMW5099336
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 02/08/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/10/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator No Information
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Patient Sequence Number1
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