MAUDE Adverse Event Report: TERUMO BCT TRIMA ACCEL; TRIMA ACCEL ENHANCED PLATELET, PLASMA, RBC SET

Catalog Number 80440

Device Problems Contamination (1120); Improper or Incorrect Procedure or Method (2017)

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

Event Date 06/19/2015

Event Type  malfunction  

Manufacturer Narrative

Investigation: per the abstract article, the primary testing for microbial contamination was performed using a minimum of 3.8% of the mother bag volume that was inoculated 24 to 36 hours post collection on 1 to 3 aerobic bottles.Components with negative results were released 12 hours post inoculation and bottles were monitored for 5 days.Platelets that expired on day 5 were maintained at manufacturing conditions and returned to the blood center.Over a period of 12 months, 60% of the expired platelets were sampled (10ml in 1 aerobic bottle) on day 7 and were incubated for a surveillance test for 24 hours.When a positive signal occurred, the bottle and platelet unit were sent to a reference microbiology lab to be evaluated and identified.Per townsend et.Al, all true positive results alarmed within 8 hours of incubation.Investigation is in process.A follow-up report will be provided.Citation: townsend, j., bravo, m., vanderpool, m., tomasulo, p., custer, b., & kamel, h.(2015).Surveillance cultures on day-7 apheresis platelets which outdated on day 5.Vox sanguinis, 103,1-3799.

Event Description

During a terumo bct review of the abstract article that was published by vox sanguinis,¿surveillance cultures on day-7 apheresis platelets which outdated on day 5¿, 7382 apheresis platelets were collected on trima and on day 7, the apheresis platelet units were cultured.Results of the cultures indicated 2 true positive microbial contamination.Per the abstract article, bacterial species isolation included coagulase-negative staphylococcus and leclercia adecarboxylata.The customer declined to provide additional information for the investigation such as procedural details, patient information, and lot information.The trima disposable sets are not available for return because it was discarded by the customer.

Manufacturer Narrative

Additional investigation: per internal documentation, the devices terumo bct manufactures to collect, separate, and store blood products are terminally sterilized to a sterility assurance level (sal) of

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: sources of bacterial contamination include but are not limited to:- improper venipuncture technique introducing bacteria at access site resulting in bacterial growth in product bag.- operator does not completely fill bact reservoir resulting in false negative platelet sample which could lead to transfusion of undetected contaminated platelet product.- inappropriate materials selected for bact sampler causing bacteria in sampler to be captured or killed resulting in false negative platelet product samples.

• Brand Name: TRIMA ACCEL
• Type of Device: TRIMA ACCEL ENHANCED PLATELET, PLASMA, RBC SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• Manufacturer Contact: steve kern ; 10810 w. collins ave; lakewood, CO 80215 ; 3032392246
• MDR Report Key: 6949519
• MDR Text Key: 90533135
• Report Number: 1722028-2017-00400
• Device Sequence Number: 1
• Product Code: GKT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: BK170059
• 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,Followup
• Report Date: 10/13/2017

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 Catalogue Number: 80440
• Other Device ID Number: 05020583804401
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/21/2017
• Initial Date FDA Received: 10/13/2017
• Supplement Dates Manufacturer Received: 01/30/2018; 02/06/2018
• Supplement Dates FDA Received: 02/02/2018; 02/26/2018
• 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