MAUDE Adverse Event Report: HAEMONETICS CORPORATION BLOODTRACK V 4.11.1

Model Number BLOOD TRACK V 4.11.1

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Death (1802)

Event Date 03/07/2020

Event Type  Death  

Manufacturer Narrative

Emergency blood was available at the haemobank but there was a delay in obtaining it.Investigation of system logs indicate that the system was functioning properly at the time.Based on the system logs the majority of the delay appears from manually typing of username and uncertainty of what username to use to access the system.A second user was able to access the system but initially used the incorrect workflow and incorrectly entered the patients' mrn but was ultimately able to obtain emergency blood using the unknown patient workflow.Additionally investigation determined that the system was not set up in the manner that haemonetics recommends.The delay was 5 min.18 sec.To retrieve blood.

Event Description

On march 8, 2020, haemonetics was informed by the customer of a device malfunction.

• Brand Name: BLOODTRACK V 4.11.1
• Type of Device: BLOODTRACK V 4.11.1
• Manufacturer (Section D): HAEMONETICS CORPORATION; 125 summer street; boston, ma
• Manufacturer (Section G): HAEMONETICS CORPORATION; 125 summer street; boston, ma
• Manufacturer Contact: shaun flanagan ; 125 summer street; boston, ma
• MDR Report Key: 9916045
• MDR Text Key: 186140766
• Report Number: 1219343-2020-00029
• Device Sequence Number: 1
• Product Code: MMH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: BK140133
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: BLOOD TRACK V 4.11.1
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/08/2020
• Initial Date FDA Received: 04/02/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/13/2018
• 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): Death