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

Catalog Number 10317

Device Problems False Positive Result (1227); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/02/2019

Event Type  Injury  

Manufacturer Narrative

Investigation: per "aspergillus species", aspergillus species is a common lab contaminate.Further testing was conducted, ct, crt and beta-d-glucan which was found to be negative.Per hoenigl, m.Et all in "performance of galactomannan, beta-d-glucan, aspergillus lateral-flow device, conventional culture, and pcr tests with bronchoalveolar lavage fluid for diagnosis of invasive pulmonary aspergillosis." , beta d glucan detection in bronchoaleveolar lavage (bal) fluid samples (gm test) is currently the gold standard test for diagnosing invasive pulmonary aspergillosis(ipa).This test was negative.Per internal sterilization 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

The customer reported that a (b)(6) girl was undergoing a continuous mononuclear cell collection (cmnc) procedure on (b)(6) 2019.Blood testing on (b)(6) showed aspergillus positive (lab result showed 1.6 for antigen test).Per the customer, the patient was negative for this prior to the optia collection.There were no clinical symptoms noted and a ct scan was performed that showed no infected nest.Further d glucan and c reactive protein(crp) blood testing was performed and there were no further related indications of contamination.Per the customer no medical intervention was required for this event.The customer transfused the collected product to the patient on (b)(6) 2019, which indicates further that this was a false positive result.The customer declined to provide patient id.The cmnc collection set is not available for return because it was discarded by the customer.This product is not available within the us, but this report is being filed due to an alleged failure that could occur on a similarly marketed device platform cleared for use by the fda.

Manufacturer Narrative

This report is being filed to provide in risk evaluation: per terumo bct's internal risk evaluation documentation, it appears unlikelythat apheresis using the spectra optia system caused the apparent false positive gm antigen testin the cmnc patient.Literature review shows there are many potential causes for the falsepositivityincluding gluconate-containing additive solutions, the specific anticoagulant used, and othersincluding contaminatiuon of the sample with the ubiquitous aspergillus spores.The most severeoutcome of a false positive gm antigen test is induction of antifungal treatment when it is notneeded.This could increase patient morbidity due to the side effects o some antifungaltreatments.Because of the recognized high level of false positivity in the gm antigen assay, apositive test is often confirmed with another test or tests as was done in the case described.Terumo bct concludes that it is very unlikely that the false positive aspergillus gm antigen testresult was related to the spectra optia cmnc procedure.Investigation: a review of the device history record (dhr) for this unit showed no irregularitiesduring manufacturing that were relevant to this issue.Investigation is in process.A follow-up report will be provided.

Manufacturer Narrative

This report is being filed to provide in investigation: per terumo bct internal medical review, there is no current evidence to suggest that the device caused or contributed to the microbial contamination.Correction: the customer identified the source of the contamination to be outside of the terumo bct device, so no relevant training to the spectra optia could be performed.Errors made by testing on a third party device are not correctable by retraining.It is of importance that the customer follow recommended industry standards pertaining to the importance of lab technique to prevent false positive.Root cause: based on the information available, aspergillus is a common lab contaminate.Based on the fact that the results from ct scan, crt and beta glucan came back negative, all tests confirm that the patient does not have aspergillosis and thus the initial aspergillus antigen is a false positive.

• Brand Name: SPECTRA OPTIA
• Type of Device: SPECTRA OPTIA IDL SET JAPAN
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• MDR Report Key: 9156760
• MDR Text Key: 164640507
• Report Number: 1722028-2019-00291
• Device Sequence Number: 1
• Product Code: GKT
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 10/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/04/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/01/2021
• Device Catalogue Number: 10317
• Device Lot Number: 1904183430
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 11/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 00015 YR
• Patient Weight: 46