MAUDE Adverse Event Report: TERUMO BCT TRIMA ACCEL; TRIMA ACCEL LRS PLT, AUTOPAS, PLASMA, SET

Catalog Number 82321

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Reaction (2414)

Event Date 03/04/2016

Event Type  Injury  

Manufacturer Narrative

Investigation: the customer stated the patient has several allergies (plasters, bees, honey,latex).The run data file was analyzed for this event.Review of the run data file indicated the targeted double platelet collection the trima accel system was collected successfully without incident.There was no indication of events during the product collection related to the reported donor reaction.Investigation is in process.A follow-up report will be provided.

Event Description

The customer reported that a donor had an anaphylactic episode at approximately 38 minutes during a platelet collection procedure.She was attended to by paramedics.They administered 500mcg of adrenaline x2, ventolin, and oxygen.She was then taken to the emergency room where she made a full recovery.Due to eu personal data protection laws, the patient identifier and age are not available from the customer.The patient gender and weight were obtained from the run data files.The disposable kit is not available for return, because it was discarded by the customer.This product is not available within the us, but this report is being filed due to a alleged failure that could occur on a similarly marketed device platform cleared for use by the fda.

Manufacturer Narrative

Investigation: the collection kit was unavailable for return for further investigation.The charge nurse believed the donor¿s reaction was to an elastic band as the donor has several allergies, including latex.The donor has donated four previous times without incident.The device history record (dhr) was reviewed for this lot.There were no issues noted in the dhr that would have contributed to the donor's allergic reaction.Root cause: a definitive root cause could not be determined for the donor¿s allergic reaction during the procedure.The procedural data file review confirmed the machine acted as designed.An allergic reaction is a known donor reaction in both whole blood donations and automated collection procedures.A possible cause is, but not limited to, contact with a material of which the donor is allergic (such as latex).

Manufacturer Narrative

Additional information: according to the aabb technical manual, adverse reactions seen at the time of donation or those reported later average about 3.5%.Per the trima accel operator¿s manual, it instructs the operator to be aware of possible adverse effects such as an allergic reaction.

• Brand Name: TRIMA ACCEL
• Type of Device: TRIMA ACCEL LRS PLT, AUTOPAS, PLASMA, SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• Manufacturer Contact: matthew bickford ; 10810 w collins ave; lakewood, CO 80215 ; 3032052494
• MDR Report Key: 5538289
• MDR Text Key: 41574636
• Report Number: 1722028-2016-00155
• Device Sequence Number: 1
• Product Code: GKT
• Combination Product (y/n): N
• Reporter Country Code: GB
• PMA/PMN Number: BK150269
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 03/31/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/31/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/01/2017
• Device Catalogue Number: 82321
• Device Lot Number: 11Y2119
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/03/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/20/2015
• 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 Outcome(s): Other
• Patient Weight: 87