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

Model Number 82406

Device Problems Contamination of Device Ingredient or Reagent (2901); Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 02/13/2022

Event Type  malfunction  

Event Description

Customer reported bacterial contamination of a double platelet unit.The bacteria was identified in anaerobic bottles 1 and 2 as diphtheroids.Donor id #: (b)(6) no patient (donor) was connected at the time of the event, therefore, no patient information is available.The platelet collection is not available for return because it was discarded by the customer.

Manufacturer Narrative

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

Manufacturer Narrative

Investigation: 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.A literature review was conducted for the organisms identified by the customer.Per literature review, diphtheroids are defined as aerobic, non-sporulating, pleomorphic gram-positive bacilli which are usually commensals of the skin and mucous membranes.Since they are usually found as commensals on the skin, they are often considered as mere contaminants when isolated from clinical samples (chandran et al, diphtheroids-important nosocomial pathogens.Journal of clinical and diagnostic research.2016 dec, vol-10(12): dc28-dc31).Per ssi-0228 technical report, 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.A disposable complaint history search was performed for all the lots and found no other reports for similar issues on these lots.A review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.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 customer¿s statement, their qc lab had contaminated the bottles resulting in false positive.

Event Description

Customer reported bacterial contamination of a double platelet unit.The bacteria was identified in anaerobic bottles 1 and 2 as diptheroids.Donor id #: (b)(6).No patient (donor) was connected at the time of the event, therefore, no patient information is available.The platelet collection is not available for return because it was discarded by the customer.

• Brand Name: TRIMA ACCEL
• Type of Device: TRIMA ACCEL PLATELET, 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: 14116613
• MDR Text Key: 298787550
• Report Number: 1722028-2022-00117
• Device Sequence Number: 1
• Product Code: GKT
• UDI-Device Identifier: 05020583824065
• UDI-Public: 05020583824065
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/15/2022

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 Expiration Date: 12/01/2023
• Device Model Number: 82406
• Device Catalogue Number: 82406
• Device Lot Number: 2112171130
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/23/2022
• Initial Date FDA Received: 04/14/2022
• Supplement Dates Manufacturer Received: 02/27/2023
• Supplement Dates FDA Received: 02/28/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/20/2021
• 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