MAUDE Adverse Event Report: HAEMONETICS CORPORATION SOFTWARE SOLUTIONS BLOODTRACK, V4.9.0, 4.9.0P1, 4.9.0P2, 4.9.0P3, 4.9.0P4, 4.10.0, 4.10.1, 4.10.2; BLOOD ESTABLISHMENT COMPUTER SOFTWARE AND ACCESSORIES

Model Number BLOODTRACK 4.9.0 - 4.10.2

Device Problem Device Difficult to Program or Calibrate (1496)

Patient Problem Death (1802)

Event Date 01/08/2018

Event Type  Death  

Manufacturer Narrative

Haemonetics has determined from the information which is currently available, there is no evidence that the delay in availability of the red blood cells stored in the locked kiosk contributed to the deaths of either the mother or child.

Event Description

On (b)(6) 2018, (b)(6) hospital, located in (b)(6) reported an incident, where emergency blood for an adult had been exhausted, due to a bleeding mother in delivery.The user required additional unit for the infant that was born during the delivery, however, the refrigerator door remained locked even though there were pediatric units available.Additionally, the kiosk screen displayed a message saying there were no emergency units available.Death did occur to the patient involved (infant) in the situation, however it is highly unlikely that the incident was the cause of death, confirmed by post mortem testing.Subsequent to this report, a defect was confirmed, which is linked to an uncommon configuration (that (b)(6) uses) that does not allow the door to be unlocked when the emergency blood for adults has been exhausted.

Manufacturer Narrative

Haemonetics has determined from the information which is currently available, there is no evidence that the delay in availability of the red blood cells stored in the locked kiosk contributed to the deaths of either the mother or child.Haemonetics has completed multiple actions to address this potential usability issue.On february 9 2018 haemonetics issued a safety alert letter to all customers utilizing the bloodtrack software version 4.9.0 or higher.Haemonetics also issued a technical bulletin bt-pb-18-01 during the month of february 2018, under which it was identified that haemonetics will investigate and address the root cause of the issue.Haemonetics is planning on releasing an updated version of bloodtrack software, version 4.11 by august 31 2018 which will address the issue of preventing the availability of pediatric-sized emergency blood units.

Event Description

On (b)(6) 2018, (b)(6) reported an incident, where emergency blood for an adult had been exhausted, due to a bleeding mother in delivery.The user required additional unit for the infant that was born during the delivery, however the refrigerator door remained locked even though there were pediatric units available.Additionally the (b)(4) screen displayed a message saying there were no emergency units available.Death did occur to the patient involved (infant) in the situation, however it is highly unlikely that the incident was the cause of death, confirmed by post mortem testing.Subsequent to this report, a defect was confirmed, which is linked to an uncommon configuration (that south hampton uses) that does not allow the door to be unlocked when the emergency blood for adults has been exhausted.

• Brand Name: BLOODTRACK, V4.9.0, 4.9.0P1, 4.9.0P2, 4.9.0P3, 4.9.0P4, 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 SOFTWARE SOLUTIONS; 4925 robert j. matthews parkwa; suite 100; el dorado hills CA 95762
• Manufacturer Contact: david ramsay ; 400 wood road; braintree, MA 02184 ; 7813487327
• MDR Report Key: 7247990
• MDR Text Key: 99226585
• Report Number: 2951268-2018-00001
• 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: foreign,health professional,u
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 05/10/2018

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?: Yes
• Device Operator: Nurse
• Device Model Number: BLOODTRACK 4.9.0 - 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: 01/15/2018
• 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