MAUDE Adverse Event Report: TERUMO BCT TRIMA ACCEL; TRIMA ACCEL PLT, SAMPLER, PLS, RBC, AUTOPAS SET

Catalog Number 000000000000080420

Device Problems Improper or Incorrect Procedure or Method (2017); Device Displays Incorrect Message (2591); Connection Problem (2900)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/11/2014

Event Type  malfunction  

Event Description

The customer reported that they received an 'ac prime failure' alarm during prime for a donation.The set was returned for evaluation and contained blood in the set, indicating that the operator had connected the donor during prime.Due to eu personal data protection laws, the patient information is not available from the customer.Donor gender and weight were obtained from the run files.This report is being filed due to device malfunction in the form of operator error that has the potential for injury.

Manufacturer Narrative

Investigation: the disposable set was returned for investigation.Upon visual inspection, it was noted that blood mixed with anticoagulant (ac) was in the set.1/3 of reservoir full with blood,blood in the return line, ac bag and spike chamber were connected properly.Blood in sample pouch and samples were taken by the customer.No missassembles was noted.The run data file (rdf) was analyzed for this event.The signals in the rdf verified that the reported alarm occurred.The rdf analysis showed that the operator may have connected the donor and unclamped the line to begin collection while on the procedure selection screen, and while the ac priming sequence was still running.Investigation is in process.A follow-up report will be provided.

Manufacturer Narrative

This report is being filed to provide additional information.Investigation: a review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.Root cause: since there was blood in the kit and the machine never went past prime, this alarm occured due to the operator attaching the donor and releasing the clamps too soon.

• Brand Name: TRIMA ACCEL
• Type of Device: TRIMA ACCEL PLT, SAMPLER, PLS, RBC, AUTOPAS SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• Manufacturer Contact: jessica kim ; 10811 w. collins ave; lakewood, CO 80215 ; 3032314812
• MDR Report Key: 4045305
• MDR Text Key: 4725550
• Report Number: 1722028-2014-00345
• Device Sequence Number: 1
• Product Code: GKT
• Combination Product (y/n): N
• Reporter Country Code: LT
• PMA/PMN Number: BK120049
• 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
• Report Date: 08/01/2014

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: 04/01/2016
• Device Catalogue Number: 000000000000080420
• Device Lot Number: 04W1111
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/01/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/24/2014
• Initial Date FDA Received: 08/28/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 09/24/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/12/2014
• 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 Weight: 89