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

Catalog Number 000000000000080483

Device Problems Disconnection (1171); Unintended Ejection (1234); Fluid/Blood Leak (1250)

Patient Problem Exposure to Body Fluids (1745)

Event Date 09/11/2014

Event Type  malfunction  

Event Description

The customer reported that the perfusion set got disconnected from the bag.The doctor, the nurse, and the patient experienced blood spray.It is not known at this time if medical intervention was necessary for this event.Due to eu personal data protection laws, the patient information is not available from the customer.This report is being filed due to the potential for injury if the same failure were to reoccur.

Manufacturer Narrative

Investigation: the rbc bag from a trima accel set was received.Dried blood was noted on the bag, particularly at the bottom of the bag.The bag including the ports were leak tested and no leaks could be identified.No defects or damage to the bag ports were observed.Investigation is in process.A follow-up report will be provided.

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.Per the customer, the collection was completed and the bag was spiked by the patient¿s bed.The nurse didn¿t find any resistance while inserting the spike into the product bag.During transfer of the product, the spike became disconnected and leaked.Some blood dripped onto the nurse,doctor, and patient.The customer confirmed that the blood did not contact any areas of non-intact skin or mucous membrane.Root cause: although a definitive root cause could not be determined, there were no defects found with the bag.Based on the customer¿s description, it is likely that either the spike was not completely inserted or there was a defect with the spike, which was not a terumo bct product.

Event Description

No medical intervention was necessary for this event.

Manufacturer Narrative

This record was identified during a retrospective review of mdrs to identify records in which an event occurred, but the type of reportable event was not indicated.

• Brand Name: TRIMA ACCEL
• Type of Device: TRIMA ACCEL PLT,PLT FILTER,AUTOPAS,PLS,RBC,TLR FILTER
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• Manufacturer Contact: jessica kim ; 10811 w. collins ave; lakewood, CO 80215 ; 3032314812
• MDR Report Key: 4251442
• MDR Text Key: 5111149
• Report Number: 1722028-2014-00454
• Device Sequence Number: 1
• Product Code: GKT
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: BK130080
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,foreign,health professi
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 10/21/2014

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: 06/01/2016
• Device Catalogue Number: 000000000000080483
• Device Lot Number: 06W2105
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/24/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/09/2014
• Initial Date FDA Received: 11/14/2014
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 12/09/2014; 07/28/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/04/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other