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

Catalog Number 10300

Device Problems Contamination (1120); Improper or Incorrect Procedure or Method (2017); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Information (3190)

Event Date 08/16/2016

Event Type  Injury  

Manufacturer Narrative

Investigation: the run data file (rdf) was analyzed for this event.No system-related root cause for the alleged bacterial contamination was identified.Review of the interface management images showed no abnormal behavior or foreign matter in the connector and signals in the rdf indicate the set was loaded and primed within the one-working shift recommendation provided in the spectra optia essentials guide.Investigation is in process.A follow-up report will be provided.

Event Description

The customer reported microbial contamination of a product collected on an optia set.At initial microbial testing, the product was negative, but after 5 days of incubation, the product had a (b)(6) test for coagulase reg.(b)(6).The unit was transfused to the patient.Prophylactic antifungal and antibiotic were given to the transfusion recipient.Patient information and outcome are not available at this time.Gender and weight in section a are for the donor.The spectra optia collect set is not available for return because it was discarded by the customer.

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.Per terumo bct's internal documentation, the devices terumo bct manufactures to collect, separate, and store blood products are terminally sterilized to a sterility assurance level (sal) of

Event Description

Due to eu personal data protection laws, the patient'sinformation and outcome are notavailable from the customer.

Manufacturer Narrative

This report is being filed to provide additional information.Additional investigation: per terumo bct's medical review, the device did not cause or contribute to this incident.

• Brand Name: SPECTRA OPTIA
• Type of Device: SPECTRA OPTIA IDL SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• Manufacturer Contact: steve kern ; 10811 w. collins ave; lakewood, CO 80215 ; 3032392246
• MDR Report Key: 5997418
• MDR Text Key: 56401673
• Report Number: 1722028-2016-00538
• Device Sequence Number: 1
• Product Code: LKN
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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
• Report Date: 10/04/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/04/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/01/2018
• Device Catalogue Number: 10300
• Device Lot Number: 05Z3325
• Other Device ID Number: 0502058310300
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/13/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/25/2016
• 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; Required Intervention
• Patient Weight: 88