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

Catalog Number 10310

Device Problem Human-Device Interface Problem (2949)

Patient Problem No Patient Involvement (2645)

Event Date 08/16/2018

Event Type  malfunction  

Manufacturer Narrative

Investigation: a review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.The phenomenon of bacterial contamination in blood products, especially platelets, is unfortunately known to occur.With current technologies, given the nature of micro-organisms on human skin and the mechanical act of piercing the skin coupled with the fact that platelets must be incubated at room temperature it is not possible to completely eliminate this phenomenon from occurring.Per internal documentation, the devices terumo bct manufactures in lakewood, co to collect, separate and store blood products are terminally sterilized to an sal of < 10-6.Additionally, a sterility assurance system has been designed and employed to ensure this sal will be achieved for every lot of product manufactured.Therefore it may be concluded that in lieu of a catastrophic failure occurring in the manufacturing process, bacterial contamination observed in collected blood products from terumo bct devices is due to the inherit hazard of collecting blood as it relates to bacterial contamination.Root cause: a definitive root cause could not be determined.Possible causes include but are not limited to:- poor phlebotomy venipuncture- post processing lab qc sampling/handling techniques.

Event Description

The customer reported that they had a positive culture from a mononuclear cell (mnc) collection product.There was not a transfusion recipient or patient involved at the time of the unit processing,therefore no patient information is reasonably known at the time of the event.The optia collection set is not available for return because it was discarded by the customer.

• Brand Name: SPECTRA OPTIA
• Type of Device: SPECTRA OPTIA IDL SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• Manufacturer Contact: steve kern ; 10810 w collins ave; lakewood, CO 80215 ; 3032392246
• MDR Report Key: 7857445
• MDR Text Key: 119659862
• Report Number: 1722028-2018-00246
• Device Sequence Number: 1
• Product Code: GKT
• UDI-Device Identifier: 05020583103108
• UDI-Public: 05020583103108
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K172590
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/07/2018

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: 04/01/2020
• Device Catalogue Number: 10310
• Device Lot Number: 1804103430
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 08/16/2018
• Initial Date FDA Received: 09/07/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/10/2018
• 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