MAUDE Adverse Event Report: TERUMO BCT TRIMA ACCEL; TRIMA ACCEL PLT,PLT FILTER,AUTOPAS,PLASMA,RBC TLR FILT

Catalog Number 000000000000080483

Device Problem Device Contamination With Biological Material (2908)

Patient Problems Death (1802); Fungus (1872)

Event Date 01/10/2014

Event Type  Death  

Event Description

The customer reported that a patient expired after being contaminated by a fungus, geotrichum clavatum.Prior to the patient contamination, the patient received a transfusion of blood product issued from a trima set.Patient information is not available at this time.The disposable set is unavailable for return because the customer discarded it.This report is being filed due to patient death, though at this time, the device is not suspected as a contributory factor.

Manufacturer Narrative

Investigation evaluation and corrective actions are in-process.A follow-up report will be provided.

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.Quality labs and sterilization requirements passed.A review of prior records for geotrichum contamination showed similar incidents out of (b)(6) in 2012.At the time, terumo bct performed a literature search for illnesses related to patients undergoing some form of hematological therapy.The literature identified that the number of patients in europe affected by fungal infections had been increasing since the late 1980's, particularly in (b)(6).Infections identified in (b)(6) were from geotrichum clavatum.The literature review also showed that geotrichum is predominantly a european pathogen mainly in mediterranean areas.Geotrichium clavatum has only been reported out of (b)(6).The literature revealed that the fungi identified in the papers are common in the environment and are found on and within human bodies.However, whenever the immune system is compromised then infections are possible.The mortality rates were very high (>(b)(4)) for patients infected with the three fungi identified in the papers, geotrichum clavatum being one type identified.Root cause: this disposable set was unavailable for specific root cause analysis.It can be concluded, and supported by several papers reviewed, that the incidents of invasive fungal infections in patients with hematological malignancies has risen over the last two decades.This increase is most likely a result of the increased use of cytotoxic therapy, allogeneic blood stem cell transplantation, and immuno suppressive therapy.The most common infections are from trichosporon species and geotrichum clavatum.There have been no other reports of infections by geotrichum clavatum outside of france since the trima platform was introduced 15 years ago.The sterilization method has remained unchanged and ethylene oxide remains the sterilant used.It is concluded that the trima accel sets, which are sterilized by ethylene oxide with a 12 log reduction of resistant bacteria endospores, are not the source of fungal contamination.

Event Description

Due to eu personal data protection laws, the patient information is not available from the customer.

Manufacturer Narrative

This record was identified during a retrospective review of mdrs to identify records in which an event occurred, but the type of reportable event was not indicated appropriately in the mdr form.This supplement is being filed to modify information to align with the reported event.

• Brand Name: TRIMA ACCEL
• Type of Device: TRIMA ACCEL PLT,PLT FILTER,AUTOPAS,PLASMA,RBC TLR FILT
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• Manufacturer Contact: jessica kim ; 10811 w. collins ave; lakewood, CO 80215 ; 3032314812
• MDR Report Key: 3612696
• MDR Text Key: 18297777
• Report Number: 1722028-2014-00039
• Device Sequence Number: 1
• Product Code: GKT
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: BK120017
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,foreign,health professi
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 01/10/2014

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/01/2015
• Device Catalogue Number: 000000000000080483
• Device Lot Number: 09V2104
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/07/2014
• Initial Date FDA Received: 02/07/2014
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 03/07/2014; 08/03/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/05/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1