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

Model Number 82446

Device Problems Microbial Contamination of Device (2303); Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 06/28/2021

Event Type  malfunction  

Manufacturer Narrative

Investigation: per the customer, they went live with a new sampling and 7 day platelets on (b)(6) 2021.Investigation is in process.A follow-up report will be provided.

Event Description

The customer reported a positive bacterial infection on a bact bottle.The pooled platelet unit tested positive for staph epidermidis.There was not a transfusion recipient or patient involved at the time of the bacterial testing, therefore no patient information is reasonably known at the time of the event.The disposables set is not available for return because it was discarded by the customer.

Manufacturer Narrative

This report is being filed to provide additional information in h.6 and h.10.Investigation: per the customer, they went live with a new sampling and 7 day platelets on 05-05-21.The customer stated that previous smaller bact 10 ml samplers was secured with clear plastic overwrap, and the needle inside had a plastic cap over it that the tech removed right before inoculation.With this updated 20 ml sampler, there is no clear plastic overwrap on the outside and no plastic cap on the needle.The new 20 ml sampler only has a flip top on the end, and the flip top has a small hole in it where the needle is open to the environment.The packaging and the sampler seem to be in a less sterile environment than before and they wanted to know the reasons for the design change.Terumo bct fpt associate informed the customer that 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.The new 20 ml sampler has a plastic overwrap but does not have the needle cap for the puncture needle.The overwrap is a visible indicator that the sampling needle/needle sheath has not been tampered with.The needle sheath and the air filter on the top of the reservoir ensure the sterility of the sampler until the time of inoculation.The bacterial strain identified are common species that live on human skin.A disposable complaint history search was performed for this lot and found no reports for microbial contamination on this lot.A review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.The trima accel operator¿s manual instructs the operator to use aseptic technique throughout all procedures to ensure donor safety and product quality.The system prompts the operator to close the blood diversion clamp on the donor access line prior to venipuncture to perform a diversion of the initial bolus of blood to the sample bag.Root cause: the specific root cause of the contamination was undetermined.The most plausible source of the contamination was determined to be the donor's skin either via skin plug at the time of phlebotomy, poor phlebotomy venipuncture technique, inadequate disinfection at collection, and/or asymptomatic donor bacteremia.Another possible cause of bacterial contamination is inadequate post-processing laboratory practices such as qc sampling or handling techniques.

Event Description

The customer reported a positive bacterial infection on a bact bottle.The pooled platelet unit tested positive for staph epidermidis.There was not a transfusion recipient or patient involved at the time of the bacterial testing, therefore no patient information is reasonably known at the time of the event.The disposables set is not available for return because it was discarded by the customer.

• 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: 12252350
• MDR Text Key: 266363924
• Report Number: 1722028-2021-00249
• 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: 07/28/2021

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: 03/01/2023
• Device Model Number: 82446
• Device Catalogue Number: 3824462
• Device Lot Number: 2103111132
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/05/2021
• Initial Date FDA Received: 07/30/2021
• Supplement Dates Manufacturer Received: 12/15/2022
• Supplement Dates FDA Received: 12/15/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/24/2021
• 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