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U.S. Department of Health and Human Services

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

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TERUMO BCT TRIMA ACCEL; TRIMA ACCEL PLATELET, PLASMA SET Back to Search Results
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.
 
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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 Key4947568
MDR Text Key21059408
Report Number1722028-2015-00464
Device Sequence Number1
Product Code GKT
Combination Product (y/n)N
PMA/PMN Number
BK140180
Number of Events Reported1
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 Date03/01/2017
Device Catalogue Number000000000000080300
Device Lot Number03Y2120
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 07/03/2015
Initial Date FDA Received07/28/2015
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/21/2015
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Age66 YR
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