MAUDE Adverse Event Report: TERUMO BCT, LTD ACDA 750ML, U.S.; ANTICOAGULANT CITRATE DEXTROSE, SOLUTION A (ACD-A)

Catalog Number 40800

Device Problems Use of Device Problem (1670); Expiration Date Error (2528); Inadequate User Interface (2958)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/11/2018

Event Type  malfunction  

Manufacturer Narrative

(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.

Event Description

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.

Event Description

Multiple attempts were made to obtain procedural details regarding the expired acda and if it was used, but no response has been received.It is unknown if the acda was used on the patient.No report of any injury or impact to the patient was reported by the customer.

Manufacturer Narrative

Investigation: the customer was unable to provide the lot number.All lots must meet quality acceptance criteria for release.Root cause: root cause was determined to be due to a user error, where the customer inadvertently used an expired product.Correction: this error was identified by the customer.The customer understood that the acda was no longer indicated for use and was discarded.No further follow-up is required.

• Brand Name: ACDA 750ML, U.S.
• Type of Device: ANTICOAGULANT CITRATE DEXTROSE, SOLUTION A (ACD-A)
• Manufacturer (Section D): TERUMO BCT, LTD; larne ; UK
• MDR Report Key: 7666039
• MDR Text Key: 113871843
• Report Number: 3001980567-2018-00001
• Device Sequence Number: 1
• Product Code: KSB
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 07/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/06/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 40800
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 06/11/2018
• Event Location: Other
• Date Manufacturer Received: 10/10/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: AMICUS MACHINE FOR MNC COLLECTION ON (B)(6) 2018.
• Patient Outcome(s): Other