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

Model Number 82446

Device Problems Gas/Air Leak (2946); Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 01/15/2022

Event Type  malfunction  

Event Description

The customer reported that during a trima donation, an "air bubble about 1" was found in the return line.Per the customer, the machine was paused by the operator before the air reached donor.No medical intervention was required.Full patient id: (b)(6) donor age is unknown at this time.Per the customer the donor was reported as "healthy" 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: a disposable complaint history search was performed for this lot and found no reports for similar issues on this lot worldwide.A review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.Per follow up from the customer the luer connections were tight, there was no clotting in the channel or in the return reservoir or air in the sample pouch.Root cause: a root cause assessment was performed for this complaint.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: * foam from plasma drain is perceived as fluid by low level sensor resulting in microbubbles in return reservoir returned to donor during plasma flush causing air embolism to donor.* a defective lower level sensor.* obstructed low level sensor due to blood clots resulting in false detection of fluid rather than air leading to air to donor.

Event Description

The customer reported that during a trima donation, an "air bubble about 1" was found in the return line.Per the customer, the machine was paused by the operator before the air reached donor.No medical intervention was required.Full patient id: w141621850711 donor age is unknown by the customer.Per the customer the donor was reported as "healthy" the platelet collection 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: 13507384
• MDR Text Key: 288174973
• Report Number: 1722028-2022-00042
• 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: 02/10/2022

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: 82446
• Device Catalogue Number: 3824462
• Device Lot Number: 2112031132
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/17/2022
• Initial Date FDA Received: 02/10/2022
• Supplement Dates Manufacturer Received: 06/07/2022
• Supplement Dates FDA Received: 06/13/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/08/2021
• 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
• Patient Sex: Male