VISTA
Received Nov 20, 2012 · Event occurred Oct 24, 2012
Report 1722028-2012-00879 · MDR key 2840598
Device
Product problems
- Excess Flow or Over-Infusion
Patient
61 YR
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
(B)(4). INVESTIGATION: IT WAS CONFIRMED WITH THE CLINIC THAT THE PROCEDURE WAS DISCONTINUED AT APPROXIMATELY 25MIN. WITH MINIMAL PRODUCT COLLECTED AND RINSEBACK WAS PERFORMED. THE DONOR HAD NO ADVERSE EXPERIENCES. THIS IS A SOFTWARE PRODUCT WHICH DOES NOT HAVE AN ASSOCIATED TECHNICAL FILE, SIMPLY A BATCH WORK ORDER WHICH WOULD DOCUMENT ANY PRODUCTION DEFECTS. NONE WERE FOUND. ROOT CAUSE: OPERATOR ERROR. CORRECTIVE ACTION: (B)(4). OPERATOR ERROR, NO EVALUATION NECESSARY.
Description of Event or Problem
THE CUSTOMER REPORTED A POTENTIAL ANTICOAGULANT (AC) OVERINFUSION DUE TO INCORRECTLY ENTERED DONOR INFORMATION. THE PROCEDURE WAS DISCONTINUED AT 25 MINUTES AND RINSEBACK WAS PERFORMED. THE DONOR DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THE INCIDENT. THIS REPORT IS BEING FILED DUE TO DEVICE MALFUNCTION (IN THE FORM OF OPERATOR ERROR) THAT HAS THE POTENTIAL TO CAUSE OR CONTRIBUTE TO A DEATH OR INJURY.