FDA.reportPublic FDA data

MAUDE MDR 7666039

MDR report key
7666039
Report number
3001980567-2018-00001
Event key
0
Event type
3
Date of event
2018-06-11
Date received
2018-07-06
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
STEVE KERN
Address
10810 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
1ACDA 750ML, U.S.ANTICOAGULANT CITRATE DEXTROSE, SOLUTION A (ACD-A)TERUMO BCT, LTDKSB40800R N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12018-07-0601. O

Event Narratives#

N

Patient 1

(B)(4). INVESTIGATION: PER THE CUSTOMER, THE OPERATOR NOTICED THAT ACDA WAS EXPIRED BEFORE CONNECTING THE PATIENT. THE CUSTOMER STATED THAT THEY REPLACED THE BAG OF EXPIRED ACDA WITH AACDA BAG THAT WAS WITHIN THE EXPIRATION DATES AND REPRIMED THE MACHINE BEFORE CONNECTING. THE INVESTIGATION IS IN-PROCESS. A FOLLOW-UP REPORT WILL BE PROVIDED.

D

Patient 1

THE CUSTOMER REPORTED THAT DURING A MONONUCLEAR CELL (MNC) COLLECTION PROCEDURE ON ANAMICUS MACHINE, AN EXPIRED BAG OF TERUMO BCT, LTD ANTICOAGULANT CITRATE DEXTROSE SOLUTION, SOLUTION A (ACDA) WAS USED ON A PATIENT. THE ANTICOAGULANT CITRATE DEXTROSE SOLUTION A (ACDA) BAG WAS LABELED WITH AN EXPIRATION DATE OF 05/01/2018. THE PROCEDURE WAS PERFORMED AND THE ACDA WAS ADMINISTERED TO THE PATIENT ON (B)(6) 2018. IT IS UNKNOWN AT THIS TIME IF MEDICAL INTERVENTION WAS REQUIRED FOR THIS EVENT. THE CUSTOMER DID NOT RESPOND TO MULTIPLE ATTEMPTS TO OBTAIN INFORMATION FOR THE INVESTIGATION SUCH AS PROCEDURAL DETAILS, PATIENT INFORMATION, AND LOT INFORMATION. PATIENT OUTCOME IS NOT AVAILABLE AT THIS TIME. THE ACDA BAG IS NOT AVAILABLE FOR RETURN BECAUSE IT WAS DISCARDED BY THE CUSTOMER.