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

Catalog Number 80440

Device Problems Air Leak (1008); Improper or Incorrect Procedure or Method (2017)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 09/16/2016

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The customer reported that after the donor was venipunctured for the collection procedure,they noticed that while the sample bag was filling with blood, it had inflated with air as well.This occurred prior to starting the procedure.Per the customer, they did not notice anything abnormal and the blue clamp was closed.Patient (donor) information and patient (donor) outcome are not available at this time.The collection set is not available for return because the customer discarded it.

Manufacturer Narrative

Investigation: a review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.Investigation is in process.A follow-up report will be provided.

Manufacturer Narrative

Root cause remains undetermined at this time.Possible causes are but not limited to: if the operator does not close the clamps on the trima accel system when instructed by the system, or if the clamps do not properly occlude the tubing during the tubing set test, air may be introduced into the sample bag.Another possible cause if there is no pressure test error, it is possible that the air reported to be observed in the sample bag is due to the residual air in the sample bag and tubing lines prior to donor connection.Corrective action: an internal capa has been initiated to evaluate reports of air in sample bag.

Event Description

The customer declined to provide patient (donor) information.The customer stated that no air was infused to the donor and no medical intervention was required for this event.

• Brand Name: TRIMA ACCEL
• Type of Device: TRIMA ACCEL PLATELET + SAMPLER, PLASMA RBC SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• Manufacturer Contact: steve kern ; 10811 w. collins ave; lakewood, CO 80215 ; 3032392246
• MDR Report Key: 6029158
• MDR Text Key: 57706437
• Report Number: 1722028-2016-00561
• Device Sequence Number: 1
• Product Code: GKT
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: BK150321
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 10/13/2016

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: 05/01/2018
• Device Catalogue Number: 80440
• Device Lot Number: 05Z4116
• Other Device ID Number: 05020583804401
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/19/2016
• Initial Date FDA Received: 10/14/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 11/07/2016; 12/02/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/19/2016
• 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