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

Catalog Number 000000000000080440

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Facial Nerve Paralysis (1846); Ischemia (1942); Transient Ischemic Attack (2109); Dysphasia (2195); Confusion/ Disorientation (2553); Complete Heart Block (2627)

Event Date 03/24/2015

Event Type  Injury  

Event Description

The customer reported that a donor had possibly suffered a 'transient stroke' after a platelet donation procedure.The donor developed facial droop on the right side, confusion and dysarthria.The donor was taken to his physician's office.Per physician's orders, a blood test, and electro-cardiogram (ekg), carotid study, and magnetic resonance imaging (mri) was given.Ekg showed no evidence of ischemic changes but was abnormal with heart block.The carotid study showed minimal plaque on one side and no occlusions.Mri scan had evidence of acute infarct, embolic in nature.Per the customer, the donor completed the donation procedure with no adverse symptoms and felt 'fine' during the procedure.The physician stated that this event is not related to the donation procedure but related to underlying medical conditions.The disposable set is not available for return because it was discarded by the customer.

Manufacturer Narrative

Additional manufacturer evaluation codes: (b)(4) manufacturing review, (b)(4) sterilization process review investigation: per the customer, during the donor's screening, an irregular pulse was detected but was within acceptable limits.The disposable kit was not available for further analysis.The rdf was reviewed and there was no unusual process variable identified.The signals in the run data file indicate that the trima accel system operated as intended.The machine was checked out at the customer site by a terumo bct service technician.It was confirmed that the machine was functioning within manufacturer specifications with no issues detected.A review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.Root cause: based on the conclusion of the physician, the root cause for the suspected transient stroke is likely the donor's physiology.The analysis of the rdf and inspection of the machine confirm that the device operated as intended.

Manufacturer Narrative

This report is being filed to provide additional information.Investigation: according to a published document which researched adverse reactions in blood and apheresis donors, severe adverse reactions are very rare and if they did occur, they were mostly mild and resolved rapidly.The physician does not feel the donation and the stroke are related.Citation: crocco, i., franchini, m., garozzo, g., gandini, a.R., gandini, g., bonomo, p., & aprili,g.(2009).Adverse reactions in blood and apheresis donors: experience from two italian transfusion centres.Blood transfusion, 7(1), 35¿38.Doi:10.2450/2008.0018-08.

Manufacturer Narrative

This record was identified during a retrospective review of mdr's, 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 in the mdr form.This supplement is being filed to modify information per fda request.

• Brand Name: TRIMA ACCEL
• Type of Device: TRIMA ACCEL ENHANCED PLATELET, PLASMA, RBC 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: 4728936
• MDR Text Key: 5580646
• Report Number: 1722028-2015-00157
• Device Sequence Number: 1
• Product Code: GKT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: BK140180
• 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
• Report Date: 04/01/2015

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: 01/01/2017
• Device Catalogue Number: 000000000000080440
• Device Lot Number: 01Y1120
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/17/2015
• Initial Date FDA Received: 04/24/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 04/30/2015; 02/10/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/21/2015
• 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 Outcome(s): Other
• Patient Age: 00079 YR
• Patient Weight: 91