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

Catalog Number 80300

Device Problems Air Leak (1008); Fluid/Blood Leak (1250)

Patient Problem Blood Loss (2597)

Event Date 09/15/2015

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The customer reported that at the beginning of a donation procedure, they observed blood leaking from the inlet tubing line and they ended the procedure.The customer provided photos of the set that was used.Upon inspection of the photos, terumo bct noted that air bubbles were present in the inlet line.There is no information at this time if any effects were experienced by the donor.Patient (donor) information is not available at this time.The disposable kit is not available for return because it was discarded by the customer.

Manufacturer Narrative

This report is being filed to provide additional information.Investigation: the customer stated that no adverse reaction was experienced and subsequent testing confirmed there was no bacterial contamination of the product.The customer was not able to provide any further details of the event.A review of the device history record for this unit showed no irregularities during manufacturing that were relevant to this issue.The customer provided a photograph of the blood leak at the donor line.Evidence points to the leak being sourced from at least one of the tubing bonds at the 2-1 connector.Air bubbles were noted in the photographs.The location of the leak, the estimated return cycle duration, and the mass of the donor allowed for a calculated intermittent air infusion rate of 0.025ml/ kg/min.Per the customer, no adverse effect was experienced by the donor.Root cause: the cause of the leak could not be definitively determined.It is possible that, but not limited to, a leak developed due to insufficient solvent, too much solvent, or handling of the tubing during transportation or at the customer site.This leak allowed air to enter this area of tubing.

Event Description

The customer declined to provide the patient's identifier and age.

Manufacturer Narrative

This record was identified during a retrospective review of mdr's to identify records in which an event occurred, but the type of reportable event was not indicated appropriately in the mdr form.This supplement is being filed to modify information in and to align with the reported event.

• Brand Name: TRIMA ACCEL
• Type of Device: TRIMA ACCEL PLATELET, PLASMA SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• Manufacturer Contact: jessica kim ; 10810 w. collins ave; lakewood, CO 80215 ; 3032314812
• MDR Report Key: 5173289
• MDR Text Key: 29259450
• Report Number: 1722028-2015-00594
• Device Sequence Number: 1
• Product Code: GKT
• Combination Product (y/n): N
• Reporter Country Code: CN
• PMA/PMN Number: BK140180
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 09/28/2015

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: 05/01/2017
• Device Catalogue Number: 80300
• Device Lot Number: 05Y2108
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/28/2015
• Initial Date FDA Received: 10/24/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 03/18/2016; 07/29/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/11/2015
• 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
• Patient Weight: 70