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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. CADD EXTENSION SET SET, ADMINISTRATION, INTRAVASCULAR

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SMITHS MEDICAL ASD, INC. CADD EXTENSION SET SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Catalog Number 21710624
Device Problem Detachment of Device or Device Component (2907)
Patient Problems Anxiety (2328); Malaise (2359)
Event Date 05/20/2021
Event Type  Injury  
Event Description
Spontaneous call from pt stating that after changing out her cassette, her cadd legacy pump started beeping due to high pressure. Patient disconnected the "line" from herself and primed the line and reattached it to herself. After a short time, the pump began to beep once more and this time the patient notice blood in the iv connection. Per patient she believes it is her iv line and not the pump since the pump did prime. She also stated she may have been without medication for 1 and a half hours. She is having anxiety issues at the moment and does not feel well. Author instructed the patient to go to the er, taking her medications and supplies with her. Patient agreed and voiced understanding. Product lot number and expiration date not provided. Unknown if product is available for return. The pumps are working since priming was no problem. This is probably related to her "chest line" since there was blood in it. Did we replace device? unknown. Did the patient have a backup device they were able to switch to? unknown. If yes, was the patient able to successfully continue their infusion? unknown. If no, what was the patient instructed to do in order to continue their infusion? unknown, pt instructed to go to er; is the infusion life-sustaining? yes. What is the outcome of the event? resolved? ongoing. 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? yes. Pt going to er. Is the actual device available for investigation? unk. Reported to (b)(6) by pt/caregiver.
 
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Brand NameCADD EXTENSION SET
Type of DeviceSET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
SMITHS MEDICAL ASD, INC.
MDR Report Key11874997
MDR Text Key252719869
Report NumberMW5101526
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 05/20/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/24/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number21710624
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Is This a Reprocessed and Reused Single-Use Device?

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