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

Catalog Number 000000000000080300

Device Problem Insufficient Information (3190)

Patient Problems Low Blood Pressure/ Hypotension (1914); Urticaria (2278); Reaction (2414)

Event Date 03/28/2015

Event Type  No Answer Provided  

Event Description

The customer reported an allergic reaction in a recipient of a platelet product collected on atrima system.The recipient had symptoms of hives and hypotension.Per the customer, the reaction was unproblematic and the patient is well.Due to eu personal data protection laws, the patient information is not available from the customer.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

Further investigation has determined that the allergic reaction of the recipient occurred with a product that was collected on a device not manufactured by terumo bct.No further evaluation will be performed for this 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 ; 10810 w. collins ave; lakewood, CO 80215 ; 3032314051
• MDR Report Key: 4947568
• MDR Text Key: 21059408
• Report Number: 1722028-2015-00464
• Device Sequence Number: 1
• Product Code: GKT
• Combination Product (y/n): N
• PMA/PMN Number: BK140180
• 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
• Report Date: 07/03/2015

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/01/2017
• Device Catalogue Number: 000000000000080300
• Device Lot Number: 03Y2120
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/03/2015
• Initial Date FDA Received: 07/28/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/21/2015
• 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 Age: 66 YR