MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS INTELLISPACE CRITICAL CARE & ANESTHESIA REV G.0; CLINICAL INFORMATION MANAGEMENT SYSTEM

Model Number 866148

Device Problems Insufficient Flow or Under Infusion (2182); Device Markings/Labelling Problem (2911)

Patient Problem Complaint, Ill-Defined (2331)

Event Date 01/15/2018

Event Type  Injury  

Manufacturer Narrative

A follow up report will be submitted once the investigation is complete.

Event Description

The customer noticed that in the configuration editor there were two orders having the same order labels but they were two different orders with different formulations.A severely ill patient received an under-dose of an antimicrobial recently due to the clinicians' selection of the duplicate/incorrect standard order; this presented a potential for septicemia.

Manufacturer Narrative

The issue is due to a configuration error.The configuration of the standard orders is restricted to a special patient type.For a standard order of ambisome there was a duplicate that did not have patient type "exclusion" configured.The customer noticed that in the configuration editor there were two orders of ambisome, one with patient type exclusion and one without patient type exclusion, both existed in the configuration dated (b)(6)2017.The stored time of both rows are (b)(6)2010 and (b)(6)2010.That indicated these data was there since 2010.This resulted in both orders having the same order labels but having different formulations.A severely ill patient received an under dose of the antimicrobial, ambisome, due to the clinicians' selection of the duplicate/incorrect standard order thus presenting a potential for septicemia.The root cause of the redundant standard orders is unknown due to the bad data in the configuration editor that was there since feb 2010.

• Brand Name: INTELLISPACE CRITICAL CARE & ANESTHESIA REV G.0
• Type of Device: CLINICAL INFORMATION MANAGEMENT SYSTEM
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; 3000 minuteman road; andover MA 01810
• Manufacturer Contact: betty harris ; 3000 minuteman road; andover, MA 01810 ; 9786871501
• MDR Report Key: 7209029
• MDR Text Key: 97861061
• Report Number: 1218950-2018-00670
• Device Sequence Number: 1
• Product Code: DXJ
• UDI-Device Identifier: 00884838075153
• UDI-Public: (01)00884838075153(10)H.02.00
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K100272
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 01/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/22/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 866148
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/15/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/24/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other