VISTA
Received Jul 26, 2012 · Event occurred Jun 29, 2012
Report 1722028-2012-00526 · MDR key 2671683
Device
Product problems
- Incorrect Or Inadequate Test Results
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
THE CUSTOMER CALLED TO REPORT THAT THE OPERATOR HAD ASSIGNED A DONOR TO A TRIMA PROCEDURE BUT THE PERSON RUN ON THE PROCEDURE WAS NOT THAT DONOR. THE TOTAL BLOOD VOLUME (TBV) THAT WAS CALCULATED WAS THEREFORE INCORRECT (IN THE UNSAFE DIRECTION, SO THE DONOR WAS RUN ON A HIGHER TBV THAN ACTUAL) FOR THIS DONOR AND THERE IS POTENTIAL FOR OVERINFUSION OF ANTI-COAGULANT. THIS WAS A SINGLE PLATELET PROCEDURE, AND THE DONOR DID NOT HAVE A REACTION DURING THE PROCEDURE, NOR DID THEY PRESENT ANY ISSUES AFTERWARD. THE CUSTOMER DECLINED TO PROVIDE THE PATIENT'S AGE OR WEIGHT. THIS REPORT IS BEING FILED DUE TO OPERATOR ERROR THAT HAS THE POTENTIAL TO CAUSE OR CONTRIBUTE TO A DEATH OR INJURY IF THIS SAME FAILURE WERE TO RECUR.
Additional Manufacturer Narrative
(B)(4). INVESTIGATION: A REVIEW OF THE PRODUCT DISPOSITION FORM (PDF) SYSTEM FOR THIS CATALOG NUMBER WAS PERFORMED AND NO PRODUCTION DEFECT RECORDS WERE FOUND. THE CUSTOMER WANTED TO KNOW THE ORDER OF OPERATIONS OF PEOPLE WHO INTERACTED WITH THE VISTA (SOFTWARE FOR ASSIGNING DONORS) SYSTEM. THIS WAS PROVIDED TO THEM VIA AUDIT TRAIL UTILITY IN VISTA. ROOT CAUSE: OPERATOR ERROR. CORRECTIVE ACTION: THE CUSTOMER IS HANDLING THE DOCUMENTATION ISSUES WITH THE RUN RECORDS ON THEIR END.