MAUDE Adverse Event Report: CAREFUSION 303, INC. ALARIS PCA MODULE; PUMP, INFUSION

Model Number UKN

Device Problems Device Alarm System (1012); Occlusion Within Device (1423)

Patient Problem Pain (1994)

Event Date 07/20/2016

Event Type  malfunction  

Event Description

Pca pump continous infusion with fentanyl 50mcg/ml 55ml monoject syringe by (b)(6), alarming occlusion.Pump changed, tubing changed,and fentanyl syringe pump changed.Pca pump restarted and continued alarming occlusion.Syringe removed and drew back air then primed fentanyl to tip of syringe and reloaded, restarted, and pca fentanyl would infuse for 3-4 hours and alarm occlusion.Hospital facility's biomedical engineering investigation initiated.The entire infusion pump, syringe and patient tubing set was tested for occlusion alarms and after 3.5 hrs, pca pump started to alarm "occlusion".Several attempts were made to restart the pca pump, the pump would alarm in a short period of time.The pca pump was stopped, the syringe removed and the tubing removed from the syringe.The tubing was tested for any flow obstructions and there were none.When the syringe was tested without the patient tubing attached, it was difficult to push the plunger to the point that it would require excessive force to drive the plunger down the barrel of the syringe and the level of force was never achieved.The syringe by (b)(6) is a monoject 60cc.Hospital testing confirmed there is an issue with this particular brand of syringe.Hospital facility waiting follow up from (b)(6) to determine further investigation with syringes due to concern that patients requiring pain medication are not receiving the appropriate amount of medications and risk if the syringe plunger were to break loose, risk of bolus given to patient.Fentanyl 50mcg/ml monoject syringe item #2k8673, ndc (b)(4).

• Brand Name: ALARIS PCA MODULE
• Type of Device: PUMP, INFUSION
• Manufacturer (Section D): CAREFUSION 303, INC.; 3750 torrey view court; san diego CA 92130
• MDR Report Key: 5999637
• MDR Text Key: 56510435
• Report Number: 5999637
• Device Sequence Number: 1
• Product Code: MEA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 08/17/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2016
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: UKN
• Device Catalogue Number: UKN
• Device Lot Number: UKN
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/17/2016
• Event Location: Other
• Date Report to Manufacturer: 08/17/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1