MAUDE Adverse Event Report: CAREFUSION ALARIS® PCA MODULE; PUMP, INFUSION

Model Number 8120

Device Problems Insufficient Flow or Under Infusion (2182); Programming Issue (3014)

Patient Problem Pain (1994)

Event Date 01/13/2016

Event Type  Injury  

Manufacturer Narrative

The device has been received and an evaluation is pending.A follow up report will be submitted once the evaluation is completed.

Event Description

The customer reported that when the pca syringe was changed from dilaudid to morphine, the pump was programmed for 1mg/dose with a 10min lockout.Approximately 2.5 hours later the patient experienced an increase in pain; when programming the device to deliver a bolus dose for the increased pain, the pump was found to be programmed for 0.2mg/dose instead of the ordered 1mg/dose.There was no patient injury reported.

Manufacturer Narrative

The customer¿s report of a programming change was confirmed.The pcu event log was not received.Since the pca module logs contain only limited information, drug and concentration selections could not be determined.Review of the pca event log showed that on (b)(6) 2016 at 8:47 pm, an ims 30ml syringe was selected.(per the directions for use, the only approved 30ml ims pump jet syringe contains morphine sulfate 1mg/ml.) between 8:54pm and 11:47pm, 13 pca doses of 0.2ml each were delivered.At 11:47 pm unspecified programming occurred.Between 11:59 pm (b)(6) and 3:42 am (b)(6), 17 pca doses of 1ml each were delivered.At 3:51am the device was powered off.The cause of the reported event was user programming.

• Brand Name: ALARIS® PCA MODULE
• Type of Device: PUMP, INFUSION
• 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: 5564357
• MDR Text Key: 42311850
• Report Number: 2016493-2016-00312
• Device Sequence Number: 1
• Product Code: MEA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K032233
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 03/15/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/08/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 8120
• Device Catalogue Number: 8120
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/31/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/19/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/17/2010
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other