VISTA INFORMATION SYSTEM
Received Jun 24, 2012 · Event occurred May 29, 2012
Report 1722028-2012-00381 · MDR key 2626923
Device
Product problems
- Device Operates Differently Than Expected
Patient
Not reported
- No Information
Narrative
Description of Event or Problem
THE CUSTOMER DECLINED TO PROVIDE THE PATIENT INFORMATION.
Additional Manufacturer Narrative
(B)(4). THIS REPORT IS BEING FILED TO PROVIDE ADDITIONAL INFORMATION. INVESTIGATION: THE PROCEDURE WAS ABORTED RIGHT AFTER PRIME DUE TO AN INFILTRATION AND NO BLOOD WAS DRAWN FROM THE DONOR. THE DONOR DID NOT HAVE A REACTION DURING THE PROCEDURE, NOR DID THEY PRESENT ANY ISSUES AFTERWARD AND NO MEDICAL INTERVENTION WAS PERFORMED. THIS IS A SOFTWARE PRODUCT WHICH DOES NOT HAVE AN ASSOCIATED TECHNICAL FILE, SIMPLY A BATCH WORK ORDER WHICH WOULD DOCUMENT ANY PRODUCTION DEFECTS. A REVIEW OF THE PRODUCT DISPOSITION FILE SYSTEM FOR THIS CATALOG NUMBER WAS PERFORMED AND NO RECORDS WERE FOUND. ROOT CAUSE: OPERATOR ERROR. THE CUSTOMER'S SALES PERSON, WAS NOTIFIED SO THAT HE COULD FOLLOW UP WITH THE CUSTOMER AND POSSIBLY CONSIDER SOME RE-TRAINING FOR THE OPERATORS.
Additional Manufacturer Narrative
(B)(4). INVESTIGATION EVALUATION AND CORRECTIVE ACTIONS ARE IN-PROCESS. A FOLLOW-UP REPORT WILL BE PROVIDED.
Description of Event or Problem
A CUSTOMER REPORTED THAT A DONOR WAS ASSIGNED TO A MACHINE, BUT THEN A DIFFERENT DONOR WAS RUN ON THAT MACHINE USING THE ORIGINAL DONOR'S INFO. THE DONOR WHO WAS ACTUALLY DRAWN ON THE MACHINE HAD A SMALLER TBV THAN THE ORIGINAL DONOR, BUT THE RUN WAS ABORTED IMMEDIATELY AFTER PRIME. THERE WAS NO DONOR REACTION AND NO BLOOD WAS DRAWN SUCCESSFULLY FROM THE DONOR. PATIENT INFORMATION IS UNAVAILABLE AT THIS TIME. THIS REPORT IS BEING FILED DUE TO AN OPERATOR ERROR THAT WOULD LIKELY CAUSE OR CONTRIBUTE TO A DEATH OR INJURY IF THIS SAME FAILURE WERE TO RECUR.