MAUDE Adverse Event Report: MCKESSON ISRAEL LTD. MCKESSON CARDIOLOGY HEMO

Model Number 13.0HF3

Device Problems Application Program Problem: Parameter Calculation Error (1449); Incorrect Software Programming Calculations (1495); Programming Issue (3014)

Patient Problems Misdiagnosis (2159); Missed Dose (2561)

Event Date 01/01/2014

Event Type  malfunction  

Event Description

The reporting facility alleged that the hemoglobin value displayed in one of the (b)(4) cardiology hemo application screens was not correctly converted in calculated results which are used to support in the treatment decision for cardiac patients.The reporting facility reviewed affected patient records and determined that no changes to treatment decisions were required.No harm to patents has been reported as a result of this issue.

Manufacturer Narrative

The mckesson investigation revealed that in specific configurations where the user clicks the 'apply local configurations for this screen to all stations' or 'apply to all stations' buttons, incorrect hemoglobin value may be utilized by the device to calculate the following clinical parameters: o2 content and o2 capacity; fick co, stroke volume and stroke work; valve area and flow; qp, qs, qe flows, shunt calculations and shunt ratio; vascular resistance; regurgitation fraction.The consequences of the incorrect calculations may potentially lead to delay in appropriate treatment or incorrect treatment.Mckesson will distribute a field safety notice to all affected customers to provide instructions for an immediate correction that will prevent this issue from occurring.Mckesson will inform affected customers of the potential impact of this issue to prior procedures, and will provide a software update to all affected customers to prevent future recurrence of this issue.To date, mckesson is not aware of any harm to patients.

• Brand Name: MCKESSON CARDIOLOGY HEMO
• Type of Device: MCKESSON CARDIOLOGY HEMO
• Manufacturer (Section D): MCKESSON ISRAEL LTD.; tel aviv ; IS
• Manufacturer Contact: paul sumner ; 5995 windward pkwy.; alpharetta, GA 30005 ; 4043383556
• MDR Report Key: 4046963
• MDR Text Key: 4866745
• Report Number: 9616760-2014-00002
• Device Sequence Number: 1
• Product Code: DQK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131497
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 04/28/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/26/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 13.0HF3
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/28/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2014
• 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