MAUDE Adverse Event Report: HAEMONETICS CORPORATION SOFTWARE SOLUTIONS BLOODTRACK® V4.8.0, 4.9.0, 4.10.0, 4.10.1, 4.10.2; BLOOD ESTABLISHMENT COMPUTER SOFTWARE AND ACCESSORIES

Model Number BLOODTRACK 4.8.0 - 4.10.2

Device Problem Use of Device Problem (1670)

Patient Problem Death (1802)

Event Date 01/18/2018

Event Type  Death  

Manufacturer Narrative

On (b)(6) a customer ((b)(6) hospital) reported that there was a delay in accessing blood for a patient due to confusion about the operation of a heamobank.The customer determined that the delay was not a factor in the ultimate outcome of the clinical situation, however, the patient died.As part of the customer's internal correction, the customer instated a retraining of the users.The issue was logged within the haemonetics complaint handling system for software complaints.The software behaved as intended, the issue appears to be primarily associated to a training issue.This appears as an isolated event, where the staff did not interact with the device appropriately.

Event Description

On (b)(6) 2018, haemonetics was notified of an incident involving the haemobank device which resulted in difficulty obtaining a unit of blood for emergency use at (b)(6) hospital (the customer).A haemonetics employee was notified in-person while meeting with the customer over lunch.A summary of the incident is as follows: a user from the delivery suite went to a haemobank to remove a unit of blood for emergency use.The user opened the door, opened the tray, removed the unit and then walked away without scanning the unit or closing the tray.Another user nearby was asked to complete the process at the refrigerator, but since the unit was no longer available to be scanned, was unable to do so.The second user closed the tray and then touched the tray empty button not realizing that if they had waited a few seconds that the system would have cleaned up the situation on its own.That triggered the haemobank to open another tray (thinking that the first tray had been empty as indicated by the user).The user touched the tray empty button two more times before ultimately letting the system time out and return to its idle state.A third user was engaged who tried to access emergency blood and also touched the tray empty button.Each time that the tray empty button is touched the logical inventory is updated to indicate that the unit that should have been in the tray is "lost" rendering the units inaccessible.The end result is that although there was blood physically in the refrigerator, some of it was no longer accessible.There was a further need for blood.Rather than going back to the haemobank (because the users were confused as to its proper use and were unsure whether there was still blood accessible), the delivery suite called for a porter to bring blood.There was confusion over the request and the porter went to the delivery suite for clarification instead of going to the blood bank to retrieve more blood.The porter then went to the blood bank, retrieved more blood and transported it back to the delivery suite.One unit was used immediately in the delivery suite and the other units were restocked into the haemobank by a fourth user.After restocking the haemobank, the fourth user (10 minutes after the last interaction with the haemobank) activated the update unit function in an attempt to correct the issues created earlier by touching the tray empty button.The user opened the tray and then stood waiting to be prompted to scan the unit not realizing that the prompt would not occur until the tray was closed.The user eventually closed the tray, scanned the unit and completed the process.In the end there was a delay in accessing blood while waiting for blood to be transported from the blood bank, but the customer determined that the delay was not a factor in the ultimate outcome of the clinical situation.Tragically, the patient died.As part of the customer's internal correction, the customer instated a retraining of the users.

Manufacturer Narrative

On (b)(6), a customer ((b)(6) hospital) reported that there was a delay in accessing blood for a patient due to confusion about the operation of a heamobank.The customer determined that the delay was not a factor in the ultimate outcome of the clinical situation, however, the patient died.As part of the customer's internal correction, the customer instated a retraining of the users.The issue was logged within the haemonetics complaint handling system for software complaints.The software behaved as intended, the issue appears to be primarily associated to a training issue.This appears as an isolated event, where the staff did not interact with the device appropriately.Haemonetics has investigated this issue and has found that the software was functioning as designed therefore no defect was identified.There are two instances where the end user did not execute the correct steps in retrieving the blood unit.Listed below are the sequence of events that contributed to the error: the first user to retrieve the blood unit from the refrigerator made an error in that they removed the unit without completing the prompts on the screen of the haemobank refrigerator.The first user then asked the second user in passing to complete the prompts on the screen of the haemobank.This was not possible since the second user did not have the physical blood unit to scan the barcode and complete the prompts as per the steps outlined in the ifu and on-screen prompts.The second user then started to press the "empty tray" button repeatedly, rather than letting the haemobank time-out.If the software were permitted to time-out, the software would have resolved this issue on its own by flagging the initial blood unit that was retrieved as no longer within the inventory of the refrigerator.As a result, the customer notified haemonetics that they have modified their training practices following this incident.Staff observation and training was conducted by (b)(6), transfusion practitioner during the month of february 2018.The transfusion practitioner can be contacted at (b)(6).

Event Description

On (b)(6) 2018, haemonetics was notified of an incident involving the haemobank device which resulted in difficulty obtaining a unit of blood for emergency use at (b)(6) hospital (the customer).A haemonetics employee was notified in-person while meeting with the customer over lunch.A summary of the incident is as follows: a user from the delivery suite went to a haemobank to remove a unit of blood for emergency use.The user opened the door, opened the tray, removed the unit and then walked away without scanning the unit or closing the tray.Another user nearby was asked to complete the process at the refrigerator, but since the unit was no longer available to be scanned, was unable to do so.The second user closed the tray and then touched the tray empty button not realizing that if they had waited a few seconds that the system would have cleaned up the situation on its own.That triggered the haemobank to open another tray (thinking that the first tray had been empty as indicated by the user).The user touched the tray empty button two more times before ultimately letting the system time out and return to its idle state.A third user was engaged who tried to access emergency blood and also touched the tray empty button.Each time that the tray empty button is touched the logical inventory is updated to indicate that the unit that should have been in the tray is "lost" rendering the units inaccessible.The end result is that although there was blood physically in the refrigerator, some of it was no longer accessible.There was a further need for blood.Rather than going back to the haemobank (because the users were confused as to its proper use and were unsure whether there was still blood accessible), the delivery suite called for a porter to bring blood.There was confusion over the request and the porter went to the delivery suite for clarification instead of going to the blood bank to retrieve more blood.The porter then went to the blood bank, retrieved more blood and transported it back to the delivery suite.One unit was used immediately in the delivery suite and the other units were restocked into the haemobank by a fourth user.After restocking the haemobank, the fourth user (10 minutes after the last interaction with the haemobank) activated the update unit function in an attempt to correct the issues created earlier by touching the tray empty button.The user opened the tray and then stood waiting to be prompted to scan the unit not realizing that the prompt would not occur until the tray was closed.The user eventually closed the tray, scanned the unit and completed the process.In the end there was a delay in accessing blood while waiting for blood to be transported from the blood bank, but the customer determined that the delay was not a factor in the ultimate outcome of the clinical situation.Tragically, the patient died.As part of the customer's internal correction, the customer instated a retraining of the users.

• Brand Name: BLOODTRACK® V4.8.0, 4.9.0, 4.10.0, 4.10.1, 4.10.2
• Type of Device: BLOOD ESTABLISHMENT COMPUTER SOFTWARE AND ACCESSORIES
• Manufacturer (Section D): HAEMONETICS CORPORATION SOFTWARE SOLUTIONS; 4925 robert j. matthews parkwa; suite 100; el dorado hills CA 95762
• Manufacturer (Section G): HAEMONETICS CORPORATION; 400 wood road; braintree MA 02184
• Manufacturer Contact: david ramsay ; 400 wood road; braintree, MA 02184 ; 7813487327
• MDR Report Key: 7248828
• MDR Text Key: 99266942
• Report Number: 2951268-2018-00002
• Device Sequence Number: 1
• Product Code: MMH
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: BK140133
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other
• Remedial Action: Notification
• Type of Report: Initial,Followup
• Report Date: 02/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/07/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Nurse
• Device Model Number: BLOODTRACK 4.8.0 - 4.10.2
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/18/2018
• Was Device Evaluated by Manufacturer?: Yes
• 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