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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CAREFUSION 303, INC. ALARIS, SMARTSITE SET, ADMINISTRATION, INTRAVASCULAR
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CAREFUSION 303, INC. ALARIS, SMARTSITE SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Model Number 2420-0500
Device Problems Device Slipped (1584); Appropriate Term/Code Not Available (3191)
Patient Problem Insufficient Information (4580)
Event Date 11/28/2021
Event Type  malfunction  
Event Description
Patient with history of coronary heart disease (cad), hypertension (htn), elevated cholesterol and malignant neoplasm of bone required an infusion # 1 of 3 - provenge (sipuleucel-t). Provenge was hanging on the iv pole. Bd alaris¿ pump module administration set was spiked into the appropriate port of the provenge. The spike fell out and provenge ran out all over the floor. No known harm to patient or staff. Provenge was ordered weekly x 3 doses. The patient went through leukapheresis to have the three doses prepared. This infusion was number 1. There are two more to be given but patient will have to go through leukapheresis again for the preparation of the 3rd dose. Clinical staff reached out to company to notify them. Notification of bag change on the back of the provenge.
 
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Brand NameALARIS, SMARTSITE
Type of DeviceSET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
CAREFUSION 303, INC.
10020 pacific mesa blvd
san diego CA 92121
MDR Report Key12770163
MDR Text Key280458343
Report Number12770163
Device Sequence Number1
Product Code FPA
UDI-Device Identifier07613203012430
UDI-Public(01)07613203012430(17)20240910(10)21093008
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 11/02/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/08/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number2420-0500
Device Catalogue Number2420-0500
Device Lot Number21093008
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA11/02/2021
Event Location Other
Date Report to Manufacturer11/08/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 11/08/2021 Patient Sequence Number: 1
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