MAUDE Adverse Event Report: HAEMONETICS CORPORATION HAEMONETICS SAFETRACETX BLOOD BANK SOFTWARE /SAFETRACETX VERSION 4.50; BLOOD ESTABLISHMENT COMPUTER SOFTWARE AND ACCESSORIES

Device Problem Data Problem (3196)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/27/2022

Event Type  malfunction  

Event Description

Red blood cell unit (b)(4) was allowed to be electronically crossmatched by the blood bank computer software (safetracetx version 4.50) when there was no valid type & screen specimen tested.The unit was then issued to the patient (b)(6) 2022 at around 10:45 pm.The order was processed using an aborh recheck specimen which did not contain an antibody screen collected (b)(6) 2022 at 10:15 am.The previous type and screen specimen had expired the day before on 9/26/2022.A new type & screen specimen had been collected on (b)(6) 2022 at 8:16 pm and was in the process of being tested when this error occurred.The product was selected and a product transfusion tag was generated stating the unit was comp (compatible).The unit was issued at around 10:45 pm.Shortly after the unit was issued, the nurse could not scan the unit using the blood product administration module in epic.The nurse was instructed to return the unit to the blood bank.The unit was returned to the blood bank spiked but none of it transfused.The unit was then discarded.This error was reported to the software manufacturer haemonetics, ticket # (b)(4).This incident is under investigation with the software manufacturer.This event caused a delay in transfusion but no other adverse out come for the patient.The new type and screen specimen was completed and reported in the computer.A different unit of blood was able to be crossmatched and issued on (b)(6) 2022 at 11:57 pm.The cls claims he issued the unit with no error messages.There were no factor overrides for this event.However, two factor messages did post, but these messages only posted under the unit activity menu which was not visible at the time of product selection to the performing cls.It appears the unit was only updated to "work in progress" and not "ready to issue".It is not clear, how the cls was able to issue a unit in "work in progress" status and not "ready to issue" status in the computer.The unit never updated to an "issued" status in the computer.It may be that the cls only thought they had issued the product in the computer but the issue did not go through.A valid type & screen specimen is required for electronic crossmatch to be performed.

• Brand Name: HAEMONETICS SAFETRACETX BLOOD BANK SOFTWARE /SAFETRACETX VERSION 4.50
• Type of Device: BLOOD ESTABLISHMENT COMPUTER SOFTWARE AND ACCESSORIES
• Manufacturer (Section D): HAEMONETICS CORPORATION
• MDR Report Key: 15625183
• MDR Text Key: 302080700
• Report Number: MW5112667
• Device Sequence Number: 1
• Product Code: MMH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/17/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1
• Treatment: EPIC EHR
• Patient Age: 83 YR
• Patient Sex: Female