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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 Problems Improper Flow or Infusion (2954); Patient Device Interaction Problem (4001)
Patient Problems Dizziness (2194); Malaise (2359)
Event Date 11/01/2022
Event Type  Injury  
Event Description
Ambrisentan prescriber rems id: (b)(4), patient rems id: (b)(4).Patient states that she had covid approximately 3 weeks ago and was not well enough to increase regularly at that time.Also around that time, patient states that she didn't realize her pump was off, was off of her remodulin for about 9 hrs, and was dizzy and not feeling well upon restarting her remodulin but thinks the covid was possibly contributing to that as well.Patient states that her tubing last night was"leaking" and had to be changed, but that patient did not have any interruption in therapy because medication from tubing was still infusing and never depleted.No issues from yesterday's tubing incident.Patient states that she is doing better since having covid (not completely 100% but better) and that she is tolerating her remodulin increases with no issues and feels that it is helping with her pulmonary arterial hypertension symptoms.No other side effects.Product problem with the "cracked" tubing, pt does not have it saved.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 Key15893431
MDR Text Key304716488
Report NumberMW5113539
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 11/28/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/30/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Is the Reporter a Health Professional? Yes
Patient Sequence Number1
Patient Age48 YR
Patient SexFemale
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