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

Catalog Number 000000000000080300

Device Problems Air Leak (1008); Device Alarm System (1012)

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

Event Date 01/07/2015

Event Type  Injury  

Event Description

The customer reported that air was observed in the return pump header during the first cycle of a procedure.There were no alarm indications by the machine.The operator ended the procedure.No medical intervention was necessary for this event.The disposable kit is not available for return because it was discarded by the customer.

Manufacturer Narrative

Investigation: the disposable set was unavailable for return and investigation.A photograph was provided by the customer.Upon photographic inspection, air was noted on the right side of the return pump header near the reservoir on the cassette and no blood in the line leading into the top of the reservoir.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 customer stated that this occurred during first return cycle.The absence of blood in the line feeding the reservoir means the inlet pump was not pumping fluid into the reservoir at the time the picture was taken.This indicates that air shown in the return pump did not actually occur during return cycle.A more likely scenario, based on the submitted picture, indicates that the air in the return line actually occurred sometime during blood prime when the return pump reverses and draws anticoagulated blood up the return line until the low level sensor is covered.In doing so, the system removes air from the draw and return lines by pumping it into the reservoir.Visibility of air in this tubing during blood prime without alarming is the normal function of the trima accel system.However, since the run data file is not available for analysis, it cannot be conclusively confirmed the air was present in the line at the end of blood prime just prior to first cycle.

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: glenda o'neill ; 10811 w. collins ave; lakewood, CO 80215 ; 3032314051
• MDR Report Key: 4491247
• MDR Text Key: 5568146
• Report Number: 1722028-2015-00047
• Device Sequence Number: 1
• Product Code: GKT
• Combination Product (y/n): N
• Reporter Country Code: CN
• 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
• Report Date: 01/14/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/06/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/01/2016
• Device Catalogue Number: 000000000000080300
• Device Lot Number: 07W2126
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/29/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/26/2014
• 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
• Patient Age: 00044 YR
• Patient Weight: 68