MAUDE Adverse Event Report: ALARIS/ CAREFUSION 303, INC ALARIS PC PUMP AND MODULE; SET, ADMINISTRATION, INTRAVASCULAR

Model Number 8015, 8100

Device Problem Excess Flow or Over-Infusion (1311)

Patient Problems Low Blood Pressure/ Hypotension (1914); Overdose (1988)

Event Date 10/01/2018

Event Type  malfunction  

Event Description

Rn set up a treprostinil infusion from the critical care adult profile.The parameters were entered correctly.After starting the infusion, the rn left the room for about 10-15 min.When she returned, she noticed a fast rate of drips in the drop chamber.When she looked at the bag it was nearly empty.Based on a rate of 0.8 ml/hr.The bag should have lasted 5 days.She turned off the pump.The rn did not notice the bag leaking.There was no fluid around the pump or floor.Three rn's that the bag said it was full (100ml) prior to hanging it.Two nurses verified the pump settings before the infusion was started.The patient's blood pressure did drop greatly immediately after this was discovered and the patient required high doses of vasopressors (which indicates he received the drug since this is a side effect of too much treprostinil).Serial numbers for devices: alaris pc pump model 8015 serial number: (b)(4) alaris module 8100 serial number: (b)(4).

• Brand Name: ALARIS PC PUMP AND MODULE
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): ALARIS/ CAREFUSION 303, INC; chicago IL 60612
• MDR Report Key: 7978894
• MDR Text Key: 124790884
• Report Number: MW5080640
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 10/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/17/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8015, 8100
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/11/2018
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other