MAUDE Adverse Event Report: TERUMO BCT TRIMA ACCEL; TRIMA ACCEL PLATELET,PLT FILTER,AUTO PAS, PLASMA SET

Catalog Number 82383

Device Problem Contamination (1120)

Patient Problem Fungal Infection (2419)

Event Date 11/02/2015

Event Type  Injury  

Manufacturer Narrative

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

Event Description

The customer reported that a patient had received a transfusion that had been collected with a trima disposable set.Following the transfusion, the patient was found to be contaminated with geotrichum clavatum.Due to eu personal data protection laws, the patient information is not available from the customer.The disposable kit 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 a alleged failure that could occur on a similarly marketed device platform cleared for use by the fda.

Manufacturer Narrative

Investigation: the customer did not provide the lot number pertaining to this event, therefore a device history record (dhr) search could not be conducted for this specific incident.All lots must meet acceptance criteria before release.Root cause: the disposable sets were unavailable for return and rdfs of the collection procedures were not available for analysis.It can be supported by several papers reviewed that the incidence of invasive fungal infections in patients with hematological malignancies has risen over the last two decades, most likely as a result of the increased use of intensive cytotoxic therapy, allogeneic blood stem cell transplantation, and immunosuppressive therapy.The most common infections are from trichosporon species and geotrichum capitatum (also known as blastoschizomyces capitatus).Infections due to geotrichum clavatum have only been reported in (b)(6) despite trima accel being commonly manufactured, sterilized, and distributed world-wide from terumo bct.The sterilization method has remained unchanged and ethylene oxide remains the sterilant used.Trima accel sets are sterilized by ethylene oxide with a 12 log reduction of resistant bacteria endospores.Fungal and yeasts organism such as geotrichum species are not capable of forming endospores.It is concluded that the sterilization cycle used to sterilize trima at terumo bct in (b)(4) has the ability to kill geotrichum if present during the sterilization cycle.Based on literature review, terumo bct sterilization method and effectiveness, and no similar complaints in other world regions where trima accel is distributed, it is concluded that the trima accel sets are not the source of the fungal contamination.Possible causes for the fungal contamination include but are not limited to patient connection to the disposable set (venipuncture), post-processing laboratory practices and handling, and/or storage procedures.

Event Description

The customer did not respond to attempts to obtain information for the investigation such as procedural details, patient status, if the patient required medical intervention, lot information,machine serial number, etc.

• Brand Name: TRIMA ACCEL
• Type of Device: TRIMA ACCEL PLATELET,PLT FILTER,AUTO PAS, PLASMA SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• Manufacturer Contact: matthew bickford ; 10810 w. collins ave; lakewood, CO 80215 ; 3032052494
• MDR Report Key: 5323472
• MDR Text Key: 34273926
• Report Number: 1722028-2015-00661
• Device Sequence Number: 1
• Product Code: GKT
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: 12/18/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 82383
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/24/2015
• Initial Date FDA Received: 12/23/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/04/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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