MAUDE Adverse Event Report: CAREFUSION ALARIS® PUMP MODULE ADMINISTRATION SET; SET,ADMINISTRATION,INTRAVASCULAR

Model Number 2420-0500

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Erythema (1840); Swelling (2091)

Event Type  Injury  

Manufacturer Narrative

Although requested, device has not been received.A follow up report will be submitted with failure investigation results should the device be received for evaluation.

Event Description

The customer reported that within the past month, there was an infusion-related reaction within 3 minutes of infusing abatacept.The patient had flushing of their face, neck, and chest, as well as a swelling sensation in those areas.The customer reported they have performed a thorough review of the investigational product and materials, and of their pharmacy¿s processes related to making the investigational product, to rule out those factors, and they have not been able to draw any conclusions.

• Brand Name: ALARIS® PUMP MODULE ADMINISTRATION SET
• Type of Device: SET,ADMINISTRATION,INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• Manufacturer (Section G): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• Manufacturer Contact: mustafa omar ; 10020 pacific mesa blvd; san diego, CA 92121-4386 ; 8586172000
• MDR Report Key: 8003355
• MDR Text Key: 124948288
• Report Number: 9616066-2018-02053
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 07613203012430
• UDI-Public: 7613203012430
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K944320
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 10/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/24/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2420-0500
• Device Catalogue Number: 2420-0500
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other