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U.S. Department of Health and Human Services

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

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SMITHS MEDICAL ASD, INC. CADD CASSETTE RESERVOIR SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Model Number 21-7302-24
Device Problem Unsealed Device Packaging (1444)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Manufacturer Narrative
Quality compliance associate.
 
Event Description
Information was received indicating that a patient was going to use a smiths medical cadd cassette reservoir to deliver reconstituted veletri (epoprostenol) for the treatment of pulmonary arterial hypertension. After filling the cassette, prior to use, the customer believed the cassette was faulty. On inspection, the top of the cassette was not sealed properly and when attempts were made at connecting to a cadd pump, the pump sensed something was wrong and alarmed. The patient only had an issue with one cassette and there were no missed doses of veletri. There was no reported adverse event.
 
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Brand NameCADD CASSETTE RESERVOIR
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 Key10130925
MDR Text Key194401158
Report Number3012307300-2020-05645
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeAS
PMA/PMN Number
K040636
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,foreign
Reporter Occupation
Type of Report Initial
Report Date 06/08/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/08/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number21-7302-24
Device Catalogue Number21-7302-24
Device Lot NumberUNKNOWN
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 Received05/13/2020
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 Initial

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