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

Catalog Number 80483

Device Problems Hole In Material (1293); Material Rupture (1546)

Patient Problem Exposure to Body Fluids (1745)

Event Date 03/25/2016

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The customer reported that at the end of a donation, the nurse had sealed the tubing of the collection set, and was removing the cassette from the machine when the clamps opened and blood sprayed onto her face.She immediately washed her face with water and her eyes with saline, then went to the emergency room.The customer stated the hole which caused the spray was located just above where the seal had been made on the tubing and was probably caused by the pressure on the tubing during cassette removal, which resulted in partial rupture of the seal.The patient (operator) age and weight are not available at this time.The disposable set is not available for return, because it was discarded by the customer.

Manufacturer Narrative

Investigation: a review of the device history record (dhr) for this unit showed noirregularities during manufacturing that were relevant to this issue.Per the customer, the opening of the weld that caused the event was located at the point of the seal safe weld, on the plasma tube, at the time the cassette was raised.Per the customer's description, the blood spray was due to an incomplete tubing weld from the safe seal system following the collection.A trima equipment preventive maintenance (pm) was performed and no issues were found.The seal safe system was checked during the pmand no issues were found.A final report of the nurse that was sprayed with blood confirmed that she was in 'fine' condition.Blood test results indicated negative test results for contamination by blood borne pathogens.Root cause: a definitive root cause of the incomplete tubing weld of the plasma line seal safe weld cannot be conclusively determined.Possible causes of an incomplete weld include but are not limited to: operator using inadequate process to make and confirm the weld anomaly in the plasma line tubing that weakened the spot where the weld was made causing the weld to fail under pressure.

Event Description

Due to eu personal data protection laws, the patient's age and weight is not available from the customer.

• Brand Name: TRIMA ACCEL
• Type of Device: TRIMA ACCEL PLT, PLT FLT, AUTOPAS,PLS,RBC, TLR FLT SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• Manufacturer Contact: matthew bickford ; 10810 w collins ave; lakewood, CO 80215 ; 3032052494
• MDR Report Key: 5718096
• MDR Text Key: 48253174
• Report Number: 1722028-2016-00368
• Device Sequence Number: 1
• Product Code: GKT
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: BK140180
• 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: 06/10/2016

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: 07/01/2017
• Device Catalogue Number: 80483
• Device Lot Number: 07Y2109
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/18/2016
• Initial Date FDA Received: 06/10/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 08/16/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/10/2015
• 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