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U.S. Department of Health and Human Services

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

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SMITHS MEDICAL ASD, INC. CADD INTRAVASCULAR ADMINISTRATION SET Back to Search Results
Model Number 21-7346-24
Device Problem Failure to Infuse (2340)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/18/2021
Event Type  malfunction  
Event Description
Information was received regarding a cadd administration set. It was reported that the writer presented to the client's house to change a cadd pump tubing. The tubing cassette was loaded into the cadd pump and the med bag spiked. Priming was initiated and the pump was sounding like it was drawing fluid, but nothing was coming into the tubing. The cassette was removed and reloaded, and user ensured the spike was fully into the med bag. The batteries were changed to ensure enough power to pull the medication through, however, there was still no fluid being pulled through the tubing. The write notified the gnh hpt program, but no solutions were provided. The writer provided the patient with new tubing from a new lot and then primed the new bag without any incidents. There was no adverse effects reported.
 
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Brand NameCADD
Type of DeviceINTRAVASCULAR ADMINISTRATION SET
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
olushola olukoga
6000 nathan lane north
minneapolis, MN 55442
MDR Report Key11743206
MDR Text Key247901956
Report Number3012307300-2021-03567
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
K031361
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Reporter Occupation
Type of Report Initial
Report Date 04/29/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/29/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number21-7346-24
Device Catalogue Number21-7346-24
Device Lot Number4084036
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 Received03/31/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/14/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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