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

Catalog Number 10310

Device Problems Microbial Contamination of Device (2303); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Bacterial Infection (1735); No Known Impact Or Consequence To Patient (2692)

Event Date 10/31/2017

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The customer reported that they received positive blood cultures on a product collected from an allogenic donor.Anerobic and aerobic blood cultures of the product grew gram positive rods propionibacterium acnes.Per the customer, the patient was transfused with the collected product prior to the blood culture testing.The patient was monitored for fever.The customer stated that the patient was 'okay' and reported in stable condition.Donor unit #: (b)(6).Patient information is not available at this time.The spectra optia collect set is not available for return because it was discarded by the customer.The allogenic donor's weight was included as a part of system limitation.

Manufacturer Narrative

This report is being filed to provide additional information and corrected information.Investigation: the device history record (dhr) was reviewed for this lot.There were no issues noted in the dhr that would have contributed to the microbial contamination as experienced by the customer.The customer reported that the culture was positive for propionibacterium acnes.Per literature review, this species is a gram-positive human skin commensal that prefers anaerobic growth conditions and is involved in the pathogenesis of acne (bhatia 2004).Per internal lab 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

Per the customer, the patient was monitored for fever following the event, with no reported reaction that the customer is aware of.The patient was cultured the next day and results were negative after 14 days.The customer was unable to determine if there was any further medical intervention.The customer declined to provide the patient identifier.

• 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: 7195106
• MDR Text Key: 98008702
• Report Number: 1722028-2018-00015
• Device Sequence Number: 1
• Product Code: LKN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K153601
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 01/16/2018

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: 02/01/2019
• Device Catalogue Number: 10310
• Device Lot Number: 02A3215
• Other Device ID Number: 05020583103108
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 12/22/2017
• Initial Date FDA Received: 01/16/2018
• Supplement Dates Manufacturer Received: 10/17/2018
• Supplement Dates FDA Received: 10/22/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/15/2017
• 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 Age: 36 YR
• Patient Weight: 73