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

Catalog Number 000000000000080400

Device Problems Clumping in Device or Device Ingredient (1095); Contamination (1120)

Patient Problem No Code Available (3191)

Event Date 05/27/2014

Event Type  Injury  

Event Description

The customer (blood donation center) reported that they had positive blood cultures on a triple platelet product.The products were collected on (b)(6) 2014 and were sent to the hospital on (b)(6) 2014 with all testing results acceptable for release.One product of the triple platelet collection was returned to the customer due to clumping on (b)(6) 2014.Testing determined that the clumping was due to bacterial contamination.The blood center notified the transfusion hospital of the contamination in regard to the other two sister products on (b)(6) 2014.A patient transfused with the second platelet product did have complications believed related to the transfusion and was in icu undergoing treatment.Donor unit #: (b)(6), patient information is not available at this time.The disposable set is not available for return for evaluation.This report is being filed due to bacterial contamination in the transfusable product.

Manufacturer Narrative

Investigation: the customer followed up with the donor.A few days post-donation, the donor had a visit to the doctor for a suspected ear infection.The donor was diagnosed with both a sinus and ear infection.Antibiotics were given and treatment started on (b)(6) 2014.Per the customer, donor had reported on the day of donation she had 'allergies'.The disposable set was unavailable for return and investigation.The run data file for the donation was analyzed and no conclusive cause for the bacterial contamination was found.There were no unusual process variables and the trima accel system operated as intended.Follow-up by the customer with the transfusion hospital on (b)(6) 2014 revealed that there had been no change in the patient condition in icu.Investigation is in process.A follow up report will be provided.

Manufacturer Narrative

Investigation: the species of bacteria was found to be cocci.Investigation is in-process.A follow-up report will be provided.

Event Description

The customer declined to provide the patient identifier, age, or weight.

Manufacturer Narrative

This report is being filed to provide additional information.Investigation: a review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.A review of the lot for similar reports was carried out, none have been reported.Root cause: the run data file shows that the system operated as intended.The disposable was not available for analysis.Based on customer statements and the follow up investigation, the root cause for the bacterial contamination is related to the donor having a sinus and ear infection, which contaminated the donated platelet product.

Event Description

The patient was reported to be treated for complications related to transfusion of bacteria contaminated product.It is unknown if icu admission was related to the transfusion.The patient's condition was last reported in (b)(6) as unchanged.No additional patient information has been provided by the customer.

Manufacturer Narrative

This record was identified during a retrospective review of mdrs, per fda request, to identify records in which a serious injury or medical intervention occurred, but the type of reportable event was not indicated as a serious injury.This supplement is being filed to modify information per fda request.

• Brand Name: TRIMA ACCEL
• Type of Device: TRIMA ACCEL PLATELET, PLASMA, RBC SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• Manufacturer Contact: jessica kim ; 10811 w. collins ave; lakewood, CO 80215 ; 3032314812
• MDR Report Key: 3908819
• MDR Text Key: 4581566
• Report Number: 1722028-2014-00255
• Device Sequence Number: 1
• Product Code: GKT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: BK120049
• 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,Followup
• Report Date: 06/05/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/01/2016
• Device Catalogue Number: 000000000000080400
• Device Lot Number: 03W1107
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/15/2014
• Initial Date FDA Received: 07/02/2014
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 07/29/2014; 10/17/2014; 02/03/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/09/2014
• 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): Hospitalization; Required Intervention