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

Model Number 2426-0007

Device Problems Fluid/Blood Leak (1250); Device-Device Incompatibility (2919)

Patient Problem Underdose (2542)

Event Date 09/06/2019

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: baxter 73¿ 1.6 ml anesthesia set with male luer lock adapter, therapy date: (b)(6) 2019.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.Patient information was requested, customer states "not available".

Event Description

It was reported that during an endobronchial ultrasound / transbronchial needle aspiration (ebus tbna) procedure on a patient, there was a failure to deliver intravenous anesthesia remifentanil / propofol due to leak.This resulted in patient starting to wake up mid-procedure.The iv anesthesia was being infused through syringe pump tubing connected to the needle-free port at y-site of an iv pump tubing with 1 liter of lactated ringer's solution infusing.It was noted by the anesthesiologist the compatibility issues between the syringe pump tubing and iv pump tubing in use.There was no patient injury.

• 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: 9151227
• MDR Text Key: 161076899
• Report Number: 9616066-2019-02799
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10885403227998
• UDI-Public: 10885403227998
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K944320
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/03/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2426-0007
• Device Catalogue Number: 2426-0007
• 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