FDA Adverse Event Malfunction Summary report: N

SAFE TRACE TX

MDR report key: 15979865 · Received December 13, 2022

Report

Report Number
MW5113776
Event Type
Malfunction
Date Received
December 13, 2022
Date of Event
December 8, 2022
Report Date
December 9, 2022
Manufacturer
HAEMONETICS CORPORATION
Product Code
OYT
Product Problem
Yes
Report Source
Voluntary report
Reporter Occupation
OTHER HEALTH CARE PROFESSIONAL
Health Professional
Yes

Narratives

Description of Event or Problem · 0

HAEMONETICS SAFETRACE (B)(6), THE BLOOD BANK INFORMATION SYSTEM USED AT MY HOSPITAL IS CERTIFIED TO PERFORM ELECTRONIC CROSSMATCHES. THIS MEANS THAT THE SYSTEM SHOULD CATCH BLOOD INCOMPATIBILITIES BETWEEN PATIENT AND DONOR UNITS. THIS PATIENT IS A , (RH) NEGATIVE, AND WAS ASSIGNED A POSITIVE UNITS ON TWO SEPARATE OCCASIONS BY TWO DIFFERENT BLOOD BANK TECHNOLOGISTS AND THE BLOOD BANK INFORMATION SYSTEM FAILED TO CATCH THE INCOMPATIBILITY. THE ERROR WAS CAUGHT DURING ISSUING, SO THE BLOOD PRODUCT NEVER LEFT THE BLOOD BANK. THE COMPUTER SYSTEM WOULD HAVE ALLOWED THE UNIT TO BE ISSUED, IT WAS ONLY CAUGHT BY THE TECH. THE BLOOD BANK SUPERVISOR HAS REACHED OUT TO HAEMONETICS ON SEVERAL OCCASIONS, BUT THE ISSUE HAS NOT BEEN RESOLVED DESPITE THE FACT THAT THIS IS A POTENTIAL LIFE THREATENING FLAW WHICH COULD NEGATIVELY IMPACT PATIENT SAFETY. THE LOGIC TABLES FOR THE SYSTEM WERE NEVER PROPERLY CONFIGURED DURING THE VALIDATION PHASE, BUT HAEMONETICS HAS FAILED TO RESOLVE THE ISSUE NEARLY 4 MONTHS LATER. IF THE LOGIC TABLES ARE INCORRECT, THEN WE CANNOT POSSIBLY SAY THAT ELECTRONIC CROSSMATCHES HAVE BEEN VALIDATED. WE SHOULD NOT BE PERFORMING ELECTRONIC CROSSMATCHES ON ANY PATIENTS UNTIL THE BLOOD BANK INFORMATION SYSTEM LOGIC TABLES HAVE BEEN FIXED AND VALIDATED. I DO NOT BELIEVE HAEMONETICS SHOULD BE ALLOWED TO SELL PRODUCTS WHICH CAN NEGATIVELY AFFECT PATIENT'S LIVES WITHOUT TAKING RESPONSIBILITY TO ENSURE THAT THE END USER HAS THEIR PRODUCT PROPERLY WORKING.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
2864680 SAFE TRACE TX BLOOD ESTABLISHMENT COMPUTER SOFTWARE AND ACCESSORIES OYT HAEMONETICS CORPORATION

Patients

Seq Age Sex Outcome Treatment
1 68 YR Male Other