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

Catalog Number 10310

Device Problems Contamination (1120); Device Disinfection Or Sterilization Issue (2909)

Patient Problem Unspecified Infection (1930)

Event Date 11/19/2015

Event Type  Injury  

Manufacturer Narrative

Investigation: the run data file was analyzed for this event.The signals in the run data file for this procedure show the system was operating as intended and there were no procedure-related events in which bacteria could have been introduced.Investigation is in process.A follow-up report will be provided.

Event Description

The customer reported a stem cell collection was not sterile and the patient required prophylactic antibotic treatment due to the contamination.Due to eu personal data protection laws, the patient information is not available from thecustomer.Donor gender and weight were obtained from the run files.The disposable kit is not available for return, because it was discarded by the customer.

Manufacturer Narrative

Investigation: a review of the device history record for this unit showed no irregularities during manufacturing that were relevant to this issue.The customer reported that the culture was positive for propionibacterium acnes.Per literature review, propionibacterium acnes is a gram positive skin bacteria that is involved in acne.During investigation of other reported events, it was found that they currently have a 20% bacterial contamination rate of their apheresis products (typically the contamination rate for autologous products is around 0-4%).This was also discussed at length, and is most likely due to improper use of the central lines.Per internal documentation, the phenomenon of bacterial contamination in blood products is known to occur.Given the nature of micro organisms on human skin and the mechanical act of piercing the skin, it is not possible to completely eliminate bacterial contamination from occurring.The devices terumo bct manufactures to collect, separate, and store blood products are terminally sterilized to a sterility assurance level (sal) of

Event Description

Per follow-up with the customer, no medical intervention was necessary.

• Brand Name: SPECTRA OPTIA
• Type of Device: SPECTRA OPTIA IDL SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• Manufacturer Contact: matthew bickford ; 10810 w collins ave; lakewood, CO 80215 ; 3032052494
• MDR Report Key: 5414783
• MDR Text Key: 37617543
• Report Number: 1722028-2016-00067
• Device Sequence Number: 1
• Product Code: LKN
• Combination Product (y/n): N
• PMA/PMN Number: BK140191
• 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
• Report Date: 02/05/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/06/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/01/2017
• Device Catalogue Number: 10310
• Device Lot Number: 08Y3119
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/01/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/19/2015
• 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
• Patient Weight: 67