MAUDE Adverse Event Report: HAEMONETICS CORPORATION BLOODTRACK; BLOOD ESTABLISHMENT COMPUTER SOFTWARE AND ACCESSORIES

Patient Problem Shock (2072)

Event Date 07/10/2023

Event Type  malfunction  

Event Description

Emergency blood refrigerator in trauma room was not functioning appropriately.A trauma code was brought in on monday [redacted date].This patient was in critical condition and required emergent blood.When staff attempted to access emergency units of blood from the fridge, there was no emergency override button present on the staff screen.Staff had to wait until the patient was registered and a patient label present in order to enter the v number to get the fridge to open.This took almost 9 min which is too long when a patient arrives in shock.Manufacturer response for blood bank refrigerator software, bloodtrack (per site reporter).

• Brand Name: BLOODTRACK
• Type of Device: BLOOD ESTABLISHMENT COMPUTER SOFTWARE AND ACCESSORIES
• Manufacturer (Section D): HAEMONETICS CORPORATION; 125 summer st; boston MA 02110
• MDR Report Key: 17905167
• MDR Text Key: 325292625
• Report Number: 17905167
• Device Sequence Number: 1
• Product Code: MMH
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 08/28/2023,07/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/10/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/28/2023
• Event Location: Hospital
• Date Report to Manufacturer: 10/10/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 14235 DA
• Patient Sex: Female