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

Catalog Number 000000000000080440

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

Patient Problem Exposure to Body Fluids (1745)

Event Date 02/14/2015

Event Type  malfunction  

Event Description

The customer reported at post collection, a lab technician was stripping the platelet product using the blue clamps and noticed a tubing disconnected from the platelet bag.The technician experienced blood spray in her eyes.Per the customer, no viral testing was performed on the technician since the product was from a long time donor who has always tested negative for viral markers.The customer stated that the technician is doing 'well' and no medical intervention was required for this event.Donor # (b)(6).Patient's 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 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.Root cause: the disposable set was unavailable for return and root cause analysis.Although a definitive root cause could not be confirmed, it is possible that excessive force was exerted onto the bag tubing while stripping the remaining product into the bag with the blue clamp.This force can cause the tubing to bag bond to fail and thus create a leak path.It is also possible that the tubing was not sufficiently bonded to the bag port.

Event Description

The customer declined to provide patient's (operator's) age and weight.

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 ENHANCED PLATELET, PLASMA, RBC SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• Manufacturer Contact: glenda o'neill ; 10811 w. collins ave; lakewood, CO 80215 ; 3032314051
• MDR Report Key: 4600752
• MDR Text Key: 16556460
• Report Number: 1722028-2015-00086
• Device Sequence Number: 1
• Product Code: GKT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: BK140180
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 02/16/2015

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: 12/01/2016
• Device Catalogue Number: 000000000000080440
• Device Lot Number: 12W1122
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/30/2015
• Initial Date FDA Received: 03/13/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 04/02/2015; 07/29/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/23/2014
• 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