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

Model Number BLOODTRACK COURIER 4.9.0

Device Problem Application Program Problem (2880)

Patient Problem Death (1802)

Event Date 04/28/2019

Event Type  Death  

Manufacturer Narrative

On (b)(6) 2019, haemonetics was notified of a possible issue with the customer's bloodtrack courier software which resulted in the touch screen requiring frequent or daily re-calibration.This issue of frequent calibration activities prompted the customer to attempt to use an external mouse and keyboard with the bloodtrack courier via the usb port on the computer, however the user guide for the bloodtrack software states that the device is equipped with a touch-screen and barcode scanner, so that a keyboard and mouse are unnecessary.The use of the external mouse and keyboard with the bloodtrack software caused some user confusion, which may have contributed to a delay in retrieving emergency blood during an emergent situation, ultimately resulting in a patient fatality on (b)(6) 2019.The customer never contacted customer support directly and customer support does not have direct access to the hospital site.On (b)(4) 2019 haemonetics was able to retrieve the data logs for further analysis, where by the following chain of events was determined to have occurred: at 02:06 on sunday morning (b)(6) 2019 the following happened.At 02:06:26.329 - someone touched the manual login button.At 02:06:40.489 - the person entered (b)(6) as their id and touched the login button.At 02:06:40.716 - (b)(6) was authorized and presented with the select action screen at 02:06:46.289 - courier was stopped.The user did not touch a button on the select action screen.The choices would have been taking out and putting in.Whether intentionally or unintentionally, the user pressed the esc key on the keyboard attached to the kiosk while on the select action screen.The user would have then had to press the esc key a second time to stop the bloodtrack courier software.The first press shows a blank screen and the second press stops the software.If esc is not pressed a second time when the user sees the blank screen, then the software will timeout after 30 seconds and return to its idle screen.The log file shows that the software stopped instead of timing out.Bloodtrack was then left off for 22 minutes and was restarted at 02:28:46.When the software stops it unlocks the door, but all of the trays remain locked and none of the trays are illuminated.It is unclear what the user was trying to accomplish.It is speculated that maybe the user thought that once the door was unlocked that the user could simply take whatever the user wanted.Given that the esc key was pressed twice, and that courier remained stopped for 22 minutes, it seems unlikely that this was unintentional.After courier was restarted, someone touched the manual login button at 02:29:03 but never completed entry of an id and did not actually login.The kiosk then sat idle until 08:14 when someone pressed the enter key on the keyboard.The kiosk displayed an invalid user id message.The manual login button was pressed at 08:44:27, 08:45:31, 08:48:34 and 08:48:47 when id (b)(6) was finally entered.Haemonetics could not see an indication of any hardware problems with the haemobank, nor was there any indication of other problems.Haemonetics surmised that the customer was using an external keyboard and the mouse because courier was being stopped in an unexpected way.The customer use of an external keyboard and mouse was confirmed by haemonetics staff due to the issue with the touchscreen losing its calibration and an ongoing problem with the worn barcodes on the staff ids.Haemonetics stated that using bloodtrack courier with an external keyboard is not a currently supported use case as some keys/key combination are not specifically handled by bloodtrack courier.The user would not have been able to touch the esc key if the user was using a touch screen.An enhancement request was created to support the use of an external keyboard in future revisions of the bloodtrack application.Additionally, haemonetics will distribute a user technical bulletin that reinforces the user's options to obtain emergency blood using the system bypass instructions.

Event Description

(b)(6) hospital is a new customer for haemonetics since (b)(6) 2019 when haemonetics obtained the maintenance contract from (b)(4).Attempts by account executive software sales to visit with the customer were denied by the blood bank manager at the time.In (b)(6) 2019, (b)(6) became the new blood bank manager.(b)(6) reached out to haemonetics (b)(4), account executive software sales and (b)(4), senior clinical application specialist, for assistance with printing user labels and was receptive to a follow-up visit from haemonetics.Haemonetics staff scheduled a customer satisfaction visit with (b)(6)hospital for (b)(6) 2019 with the new blood bank manager (b)(6).During the customer satisfaction visit, haemonetics was informed about an issue with the touch screen of the kiosk.(b)(6) mentioned that he placed a support call and was directed on how to calibrate the screen.He also mentioned that re-calibration had to be done often, almost daily.Due to this issue, (b)(6) had opted to install a keyboard and mouse on the kiosk using a usb hub, so that the users could interact with the kiosk not using the touch screen or barcode scanner.Haemonetics staff noticed when they went to the trauma room (ed) and met staff that there was a misunderstanding on how the system works, the employee bloodtrack user ids were faded and barely usable and newer staff did not have a bloodtrack user id.Training continued on (b)(6) 2019 where haemonetics staff clarified how the system works e.G.That there is no need for an order, that the patient doesn't have to be admitted and how the system in any case will provide o negative uncrossmatched blood.During discussions with (b)(6) hospital staff, haemonetics was informed about an issue where on sunday (b)(6) 2019 a patient with abdominal stabbing came in around 2 am, the user was not able to get blood from the haemobank 20 using the bloodtrack courier software and by the time the blood came from the blood bank, the patient had passed away.

• Brand Name: BLOODTRACK COURIER
• Type of Device: BLOOD ESTABLISHMENT COMPUTER SOFTWARE AND ACCESSORIES
• Manufacturer (Section D): HAEMONETICS CORPORATION; 400 wood road; braintree MA 02184
• Manufacturer (Section G): HAEMONETICS CORPORATION; 400 wood road; braintree MA 02184
• Manufacturer Contact: david ramsay ; 400 wood road; braintree, MA 02184
• MDR Report Key: 8651771
• MDR Text Key: 146463963
• Report Number: 2951268-2019-00001
• 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,user faci
• Reporter Occupation: Administrator/Supervisor
• Remedial Action: Notification
• Type of Report: Initial
• Report Date: 05/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/29/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: BLOODTRACK COURIER 4.9.0
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/03/2019
• Date Manufacturer Received: 05/02/2019
• 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