FDA Adverse Event Malfunction Summary report: N

CHANGE HEALTHCARE CARDIOLOGY HEMO

MDR report key: 19844346 · Received July 26, 2024

Report

Report Number: 8022257-2024-00002
Event Type: Malfunction
Date Received: July 26, 2024
Report Date: July 26, 2024
Manufacturer: CHANGE HEALTHCARE CANADA COMPANY
Product Code: MWI
UDI-DI: 17540262100129
PMA / PMN Number: K131497
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: MA, US
Reporter Occupation: NURSE
Health Professional: Yes

Narratives

Additional Manufacturer Narrative · 0

AFTER CONDUCTING A THOROUGH INVESTIGATION INTO THE CUSTOMER'S USE ERROR, CHANGE HEALTHCARE HAS DETERMINED THAT ALL SOFTWARE FUNCTIONALITY RELATED TO CHANGING THE UOM WAS WORKING AS EXPECTED. HOWEVER, CHANGE HEALTHCARE IS ANALYZING WHETHER THE USER INTERFACE DESIGN WAS EFFECTIVE ENOUGH TO TIMELY ALERT THE USER.

Description of Event or Problem · 0

CHANGE HEALTHCARE CARDIOLOGY HEMODYNAMICS PROVIDES HEMODYNAMIC CALCULATIONS AND FORMULAS. THE SETTINGS, SUCH AS UNIT OF MEASUREMENT (UOM), FOR THESE FORMULAS AND CALCULATIONS ARE CONFIGURED IN THE CHANGE HEALTHCARE MANAGEMENT CONSOLE (CHMC) AND ARE DESIGNATED BY THE SITE ACCORDING TO FACILITY STANDARDS. IN THIS EVENT, THE UOM FOR THE HEMOGLOBIN VALUE, USED AS PART OF THE HEMODYNAMICS FORMULAS, WAS CONFIGURED IN THE CHMC AS MMOL/L (MILLIMOLES/LITER). HOWEVER, THE CLINICAL STAFF CONTINUED TO MANUALLY ENTER THE HEMOGLOBIN VALUE AS G/DL (GRAMS/DECILITER) WITHOUT BEING AWARE OF THE CHANGED CONFIGURATION FOR THE UOM. NO ADVERSE HEATH CONSEQUENCES RESULTING FROM THIS ISSUE WERE REPORTED TO CHANGE HEALTHCARE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
458853	CHANGE HEALTHCARE CARDIOLOGY HEMO	MONITOR, PHYSIOLOGICAL, PATIENT (WITHOUT ARRHYTHMIA DETECTION OR ALARMS)	MWI	CHANGE HEALTHCARE CANADA COMPANY	15.1		17540262100129

Patients

Seq	Age	Sex	Outcome	Treatment
1	NA	Unknown