FDA.reportPublic FDA data

MAUDE MDR 2671683

MDR report key
2671683
Report number
1722028-2012-00526
Event key
0
Event type
3
Date of event
2012-06-29
Date received
2012-07-26
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
3
Initial report to FDA
3
Event location
0

Manufacturer Contact#

Contact
MS. KRISTEN COHEN
Address
10811 W. COLLINS AVE LAKEWOOD CO 80215 US
Phone
303-303-3032
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1VISTAVISTA INFORMATION SYSTEMTERUMO BCTNYO923000320*

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12012-07-2601. O

Event Narratives#

D

Patient 1

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.

N

Patient 1

(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.