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

Model Number 24010-0007T

Device Problems Fluid/Blood Leak (1250); Insufficient Information (3190)

Patient Problem No Information (3190)

Event Date 10/28/2019

Event Type  malfunction  

Manufacturer Narrative

Unable to determine the cause of the customer's reported complaint because the set has been discarded by the customer and will not be returned.The root cause of this failure could not be identified.

Event Description

It was reported that the pump was beeping air-in-line during a cisplatin (chemotherapy) infusion.The channel was discovered to be wet and the tubing had leaked.The infusion was replaced.This event occurred in an inpatient unit.

• 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: stephen bilello ; 10020 pacific mesa blvd; san diego, CA 92121-4386 ; 8586172000
• MDR Report Key: 9536336
• MDR Text Key: 179421374
• Report Number: 9616066-2019-03788
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10885403271021
• UDI-Public: 10885403271021
• 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: 12/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 24010-0007T
• Device Catalogue Number: 24010-0007T
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/31/2019
• 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