MAUDE Adverse Event Report: TERUMO BCT SPECTRA OPTIA; SPECTRA OPTIA COLLECT SET

Catalog Number 10300

Device Problems Device Expiration Issue (1216); Inadequate User Interface (2958)

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

Event Date 02/08/2018

Event Type  malfunction  

Manufacturer Narrative

Lot number, manufacture date and expiry are not available at this time.Investigation is in process.A follow-up report will be provided.

Event Description

The customer reported that during a white blood cell depletion (wbcd) procedure, an expired spectra optia disposable set was used on a patient.The spectra optia set was labeled with an expiration date of 01/01/2018.The procedure was performed on (b)(6) 2018.It is unknown at this time if medical intervention was required for this event.Patient¿s information is not available at this time.Patient outcome is not available at this time.Terumo bct is awaiting return of the spectra optia disposable set for evaluation.

Manufacturer Narrative

This report is being filed to provide additional information and corrected information.Investigation: a review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.Investigation is in process.A follow-up report will be provided.

Event Description

Due to eu personal data protection laws, the patient information and outcome are not available from the customer.

Manufacturer Narrative

This report is being filed to provide additional information and corrected information.Root cause: the customer confirmed that they discovered the error after the completion of the procedure, and that the root cause was due to an operator error.There was no alleged machine malfunction.

Event Description

The spectra optia set is not available for return because it was discarded by the customer.

Manufacturer Narrative

This report is being filed to provide additional information.Additional investigation: terumo bct has followed up with this customer to provide feedback on the reported condition.The customer communicated with their staff the importance of checking the expiration date on the set prior to the procedure.

• Brand Name: SPECTRA OPTIA
• Type of Device: SPECTRA OPTIA COLLECT SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• Manufacturer Contact: steve kern ; 10810 w. collins ave; lakewood, CO 80215 ; 3032392246
• MDR Report Key: 7317253
• MDR Text Key: 101971595
• Report Number: 1722028-2018-00062
• Device Sequence Number: 1
• Product Code: GKT
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K153601
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 03/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/01/2018
• Device Catalogue Number: 10300
• Device Lot Number: 01Z3127
• Other Device ID Number: 05020583103009
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 05/15/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/27/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other