MAUDE Adverse Event Report: SUMMIT MEDICAL PRODUCTS, INC. AMBIT PCA PUMP

Model Number 220262

Device Problem Excess Flow or Over-Infusion (1311)

Patient Problem Overdose (1988)

Event Date 03/25/2015

Event Type  malfunction  

Event Description

It was alleged that the pump over infused the pt and the pump on its own administered additional medication.The clinician reported the pumps settings at 5.0.Ml/hr, 10 ml bolus, 01:00 lockout time, 300 ml bag.When the clinician turned the pump on, the display showed 16 ml's.The pump bolus was pressed and the pump continued to run till the pump display showed 28 ml's.There was no pt injury/intervention.

Manufacturer Narrative

Before any testing was started, the pump settings were reviewed.It appears the settings initially reported by the clinician of 5.0 ml/hr, 10 ml bolus, 300 bag had been changed.The history of the alleged 28 ml's had been cleared.The settings were 0.0 ml/hr, 0.0, bolus, 25 ml bag.The history was set to 0.Several performance tests were conducted, including trying to re-create the alleged failure of the pump spontaneously running past the programmed rates could not be confirmed.The pump was evaluated and found to perform as specified for each performance test.At no time during the eval, powering on/off the pump did the pump spontaneously run passed its programmed rate.Due to the internal memory in the pump and the self check when the pump is powered on, it is virtually impossible for the pump to inadvertently change or run past its programmed rate in the middle of the infusion therapy.Summit medical believes that the error was due to use error.Based on the info provided, it appears the history of 16 ml's from a previous infusion was not cleared prior to starting the infusion therapy.When the pump was turned on and bolused and ran the programmed rate of 10 ml's plus part of the 5 ml basal.Had the history would have been cleared prior to use, this error would have been caught.

• Brand Name: AMBIT PCA PUMP
• Type of Device: AMBIT PCA PUMP
• Manufacturer (Section D): SUMMIT MEDICAL PRODUCTS, INC.
• Manufacturer (Section G): INTEGRA BIOTECHNICAL, LLC
• Manufacturer Contact: 504 w 8360 s; sandy, UT 84070
• MDR Report Key: 4772522
• MDR Text Key: 5786215
• Report Number: 1722214-2015-00001
• Device Sequence Number: 1
• Product Code: MEA
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 05/06/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 220262
• Device Catalogue Number: 220262
• Device Lot Number: 012003
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 03/14/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/14/2015
• Initial Date FDA Received: 05/11/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/06/2010
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1