MAUDE Adverse Event Report: TERUMO BCT COBE SPECTRA; COBE SPECTRA DN LRS SET, ISBT

Catalog Number 70300

Device Problems Improper or Incorrect Procedure or Method (2017); Device Operates Differently Than Expected (2913)

Patient Problem No Patient Involvement (2645)

Event Date 04/27/2017

Event Type  malfunction  

Manufacturer Narrative

Investigation is in-process.A follow-up report will be provided.

Event Description

The customer would like the run data file investigated to determine a possible cause for the elevated white blood cell (wbc) content in the platelet product.There was not a transfusion recipient or patient involved at the time of the residual white bloodcell (rwbc) testing, therefore no patient information is reasonably known at the time of theevent.The cobe spectra set is not available for return because it was discarded by the customer.

Manufacturer Narrative

Investigation: the customer declined to provide complainant's first name.The device history records (dhr) were reviewed for this lot.There were no events noted in the dhr that would have contributed to the elevated wbc count experienced by the customer.The cobe spectra apheresis system is not designed to proactively alert the operator to the wbc count.No message will be received at the end of a procedure to verify wbc count in the product.Root cause: a definitive root cause could not be determined.Possible causes include but are not limited to:¿ wbc count methodology¿ rbc spillover¿ centrifuge stopped¿ rbc detector calibration error¿ possible air block¿ the orientation of the tubing as loaded in the centrifuge hex holder and the compromised structural integrity of the plasma tubing.Effectively, there is a certain orientation in the hex holder that allows for the rbc line to lie on top of the plasma line and, under certain flow conditions, may cause the plasma line to pinch off.This in turn causes higher flow through the lrs chamber, which may lead to elevated levels of wbcs in the platelet product.

Manufacturer Narrative

This report is being filed to provide additional information.Additional investigation: the customer stated that a cell dyne ruby cell counter to determine the level of residual wbcs in the product.The cell counter¿s product information was reviewed by terumo bct.Depending on the manner in which the counter is being used, it is possible that the use of this instrument exceeds the manufacturer's specifications for detecting measureable wbc counts.

• Brand Name: COBE SPECTRA
• Type of Device: COBE SPECTRA DN LRS SET, ISBT
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• Manufacturer Contact: steve kern ; 10810 w. collins ave.; lakewood, CO 80215 ; 3032392246
• MDR Report Key: 6663508
• MDR Text Key: 78514246
• Report Number: 1722028-2017-00253
• Device Sequence Number: 1
• Product Code: GKT
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: BK020041
• 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
• Report Date: 06/23/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/01/2017
• Device Catalogue Number: 70300
• Device Lot Number: 12Y15228
• Other Device ID Number: 05020583703001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/01/2017
• Initial Date FDA Received: 06/23/2017
• Supplement Dates Manufacturer Received: 05/31/2017; 08/04/2017
• Supplement Dates FDA Received: 07/18/2017; 08/08/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/03/2015
• 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