MAUDE Adverse Event Report: CAREFUSION ALARIS INFUSION SET; SET, INFUSION, INTRAVASCULAR

Model Number 2260-0500

Device Problem Insufficient Flow or Under Infusion (2182)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

No product will be returned per customer.The customer complaint could not be confirmed because the product was not returned for failure investigation.The root cause of this failure was not identified.

Event Description

The customer reported that during an unspecified chemotherapy infusions, it was noted that there is medication remaining in line after the completion of the infusion.The nurses finish administering the remaining medication left in the line by using gravity.It was reported that when using both the non-filtered and the filtered line iv sets during the gravity process, blood from the patient returns into the line after the set has been in use for a range of 15 minutes to two hrs.The clinicians are requesting to have the "valve" on the pump lines so the patients¿ blood is not coming into the line and they are able to administer all of the medication during treatment.The event ¿occurred has on multiple occasions but started around the beginning of december¿.There was no report of patient harm.The event is occurring cancer infusion center.

• Brand Name: ALARIS INFUSION SET
• Type of Device: SET, INFUSION, 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: ade ajibade ; 10020 pacific mesa blvd; san diego, CA 92121-4386 ; 8586172000
• MDR Report Key: 8207059
• MDR Text Key: 131769445
• Report Number: 9616066-2018-02627
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 07613203012591
• UDI-Public: 7613203012591
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K931173
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/31/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/19/2021
• Device Model Number: 2260-0500
• Device Catalogue Number: 2260-0500
• Device Lot Number: 18016349
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/19/2018
• 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