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

Model Number 82446

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/11/2021

Event Type  malfunction  

Manufacturer Narrative

Lot number and expiry information are not available at this time.Investigation is in process.A follow-up report will be provided.

Event Description

The customer reported an increase in (b)(6) bac-t sample results.Donor unit #: (b)(6) the platelet collection is not available for return because it was discarded by the customer.There was not a transfusion recipient or patient involved at the time of the unit processing, therefore no patient information is reasonably known at the time of the event.

Event Description

The customer reported an increase in positive bac-t sample results.Donor unit #: w091021357755 the platelet collection is not available for return because it was discarded by the customer.There was not a transfusion recipient or patient involved at the time of the unit processing, therefore no patient information is reasonably known at the time of the event.

Manufacturer Narrative

This report is being filed to provide additional information in h.6 and h.10.Investigation: bpa culture bottles are used with the bact/alert® microbial detection systems for quality control testing of platelets.Bact/alert bpa culture bottles support the growth of aerobic microorganisms (bacteria and fungi).Bpn culture bottles are used with the bact/alert® microbial detection systems for quality control testing of platelets.Bact/alert bpn culture bottles support the growth of anaerobic and facultative anaerobic microorganisms (bacteria).The 20 ml large volume bact samplers increase the volume of inoculum hence better detection of contaminated units with a low bacterial titer.An increase in positive tests is a possibility with enhanced sensitivity.Multiple attempts were made to obtain additional information including the disposable lot number, machine serial numbers, bacterial strains and status of the recipient who had been transfused with products allegedly contaminated with bacterial.The customer did not respond to any of the requests.Triple unit din w091021357755 had 4/6 initial positive samples.All of the platelet products associated with this din expired.The phenomenon of bacterial contamination in blood products, especially platelets, is known to occur.With current technologies, given the nature of microorganisms on human skin and the mechanical act of piercing the skin coupled with the fact that platelets must be incubated at room temperature it is not possible to eliminate this phenomenon from occurring.The devices terumo bct manufactures in lakewood / littleton, co, vietnam, costa rica and harmac to collect, separate and store blood products are terminally sterilized to an sal of < 1.0 x 10-6.Additionally, a sterility assurance system has been designed and employed to ensure this sal will be achieved for every product manufactured.Therefore, it may be concluded bacterial contamination observed in collected blood products from terumo bct devices is most likely due to the inherit hazard of collecting blood as it relates to bacterial contamination.The customer did not provide the disposable lot number.All lots must meet acceptance criteria for release.Root cause: a root cause assessment was performed for the microbial contamination with true positive and indeterminate results.Based on the available information a definitive root cause could not be determined but it is likely due to one or a combination of the possible causes listed below: * improper venipuncture technique introduces bacteria at access site resulting in bacterial growth in product bag.* inadequate or no blood diversion performed due to operator error resulting in bacterial contamination of product.* species was endogenous and originated from the donor.* inadequate post-processing laboratory practices such as qc sampling or handling techniques.A root cause assessment was performed for the microbial contamination with false positive results.Based on the available information, their qc lab had contaminated the bottles resulting in false positive.

• Brand Name: TRIMA ACCEL
• Type of Device: TRIMA PLATELET+SAMPLER, PLASMA, RBC SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• Manufacturer (Section G): TERUMO BCT; 10810 w. collins ave; lakewood CO 80215
• Manufacturer Contact: scot hilden ; 10810 w. collins ave; lakewood, CO 80215
• MDR Report Key: 12682389
• MDR Text Key: 280510768
• Report Number: 1722028-2021-00334
• Device Sequence Number: 1
• Product Code: GKT
• UDI-Device Identifier: 05020583824461
• UDI-Public: 05020583824461
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: BK190332
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date: 10/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/22/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 82446
• Device Catalogue Number: 82446
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/09/2023
• Was Device Evaluated by Manufacturer?: No
• 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