CPOE/EHR DEVICE *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-04-15 for CPOE/EHR DEVICE * manufactured by Pro Touch/kindred.

Event Text Entries

[5651370] The patient has multiorgan failure though was improving, weaning from the ventilator, recovering from sepsis, and on 3 days per week renal dialysis. The patient was ordered normal saline to run at a rate of 75 cc per hour. This cpoe order for intravenous fluid was entered one week prior to the event, by a consultant who was doing a procedure on this patient. The patient complained of exacerbation of dyspnea and was found to have pulmonary edema on chest radiography. On detailed review of mar (medicine list), it was determined that the intravenous fluid for the procedure was never discontinued as its listing in the mar was midway through more than a page/screen of medications and was not listed in a category headed as "intravenous medications and fluids. " because the patient was anuric, the fluid accumulated in the lungs, resulting in deterioration of the respiratory failure, requiring more dialysis. Over the course of the week, the patient received 12 litres of extra fluid based on an order from a sporadic consultant, which was missed by several physicians, nurses, and pharmacists, each day. The user interface was flawed, obfuscating the order amidst medication orders, and there was a failure of decision support reminders.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5042158
• MDR Report Key: 4713787
• Date Received: 2015-04-15
• Date of Report: 2015-04-15
• Date of Event: 2015-04-02
• Date Added to Maude: 2015-04-22
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 0
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: CPOE/EHR DEVICE
• Generic Name: CPOE/EHR DEVICE
• Product Code: NSX
• Date Received: 2015-04-15
• Model Number: *
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: PRO TOUCH/KINDRED
• Manufacturer Address: * LOUISVILLE KY 40202 US 40202

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Hospitalization; 2. Life Threatening; 3. Required No Informationntervention	2015-04-15