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

Model Number 2420-0500

Device Problems Detachment Of Device Component (1104); Fluid/Blood Leak (1250)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/17/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The customer reported that the tubing broke at the male luer spin collar and leaked while infusing a chemotherapeutic medication on more than one occasion.There was no patient harm.Received a copy of the customer's sus voluntary event report from fda, which states ¿veteran reported to nursing desk that he had broken his line.Upon inspection it was determined that patients iv tubing had broken apart at the hub.A chemotherapeutic agent (5fu) was spilled on the floor and bedding.Chemo spill protocol was initiated.Housekeeping used detergent and water rinses to floor and bed.Veteran iv site was assessed for damage, and md and pharmacy notified.Exposure forms were filled out and given to supervisor.I was told from unit staff this has happened many times this is the first event that i have seen with regards to this type.".

• 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: ade ajibade ; 10020 pacific mesa blvd; san diego, CA 92121-4386 ; 8586172000
• MDR Report Key: 7654740
• MDR Text Key: 112872269
• Report Number: 9616066-2018-00946
• Device Sequence Number: 1
• Product Code: FPA
• 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: health professional,user faci
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 06/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/02/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/29/2021
• Device Model Number: 2420-0500
• Device Catalogue Number: 2420-0500
• Device Lot Number: 18015721
• Other Device ID Number: 7613203012430
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/12/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/29/2018
• 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