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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
Device Problems Device Alarm System (1012); Obstruction of Flow (2423); Pressure Problem (3012)
Patient Problem Respiratory Distress (2045)
Event Date 11/07/2020
Event Type  Injury  
Manufacturer Narrative
Concomitant devices: 2 cadd pumps.
 
Event Description
Information was received indicating that the patient called to report a high pressure alarm on a cadd pump being used with a smiths medical cadd extension set. The patient troubleshooted, but could not find any obstructions in the line. The patient used a backup pump which ended up failing for the same issue. The patient went to the hospital where it was discovered that the pressure issue was due to the cadd extension tubing and not the patient's hickman line. The patient was not changing the extension set 3 times a week. The patient did experience difficulty breathing. The patient had a backup device and was able to continue the life sustaining infusion of veletri 1. 5mg vial.
 
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Brand NameCADD EXTENSION SET
Type of DeviceSET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
SMITHS MEDICAL ASD, INC.
6000 nathan lane north
minneapolis MN 55442
Manufacturer (Section G)
SMITHS MEDICAL ASD, INC.
6000 nathan lane north
minneapolis MN 55442
Manufacturer Contact
david halverson
6000 nathan lane north
minneapolis, MN 55442
MDR Report Key11120356
MDR Text Key225253424
Report Number3012307300-2021-00086
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Reporter Occupation
Type of Report Initial
Report Date 01/05/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/05/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received12/07/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 01/05/2021 Patient Sequence Number: 1
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