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

Catalog Number 80400

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

Patient Problems Stroke/CVA (1770); Weakness (2145); Numbness (2415)

Event Date 05/06/2016

Event Type  malfunction  

Manufacturer Narrative

Investigation: the customer stated that during the donation, there were several 'drawpressure too low' alerts, but that is normal for this donor.The run data file was analyzed for this event.No unusual process variable was identified and thesignals in the run data file indicate that the trima accel system operated as intended.Specifically,there is no indication of an anticoagulant overinfusion, hypovolemia or a depletion of platelets orred blood cells that could have contributed to complications post donation.Investigation is in progress.A follow-up report will be provided.

Event Description

The customer reported that a little over 24 hours post donation of a triple platelet product, a donor was admitted to the hospital for a possible stroke.The donor had called the donation center to complain of a weakness/numbness in her left arm.According to the customer, the symptoms became worse and the medical director advised the donor to be seen in the emergency room.The donor was hospitalized, treated for a possible stroke and released.Two days later the center called back for follow-up with the donor, and they were informed that the donor had been readmitted to the hospital.The center has been unable to contact the donor for any further follow-up.Donor's full (b)(6).The disposable set is not available for return, because it was discarded by the customer.

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 checkout of the machine was performed by a terumo bct technician.An autotest and saline run were performed to verify function.No issues were found.Root cause: a definitive root cause could not be determined.Per the run data file, there was no indication of an ac overinfusion, hypovolemia or a depletion of platelets or red blood cells that could have contributed to complications post donation.Based on the customer's description of events, the procedural report, and machine inspection, no malfunction of the device occurred.

Manufacturer Narrative

Investigation: the customer stated that no further information is available as the blood center has been unable to contact the physician.According to aabb technical manual, reactions that need medical care after the donor has left the donation site are seen in 1 in 3,400 donors.However, per terumo bct's medical review,there is no evidence that the device caused or contributed to the outcome of the reported event.Updated root cause: a definitive root cause could not be determined.Based on the information available, the customer did not allege a deficiency with the machine, the machine performed as expected, and the procedure was completed with no abnormalities.Upon review by terumo bct clinical safety group, the device did not cause of contribute to the outcome of the reported event.A possible cause includes, but not limited to, donor physiology.

• Brand Name: TRIMA ACCEL
• Type of Device: TRIMA ACCEL PLATELET, PLASMA, RBC SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• Manufacturer Contact: matthew bickford ; 10810 w collins ave; lakewood, CO 80215 ; 3032052494
• MDR Report Key: 5732472
• MDR Text Key: 47625887
• Report Number: 1722028-2016-00373
• Device Sequence Number: 1
• Product Code: GKT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: BK150269
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 06/17/2016

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: 03/01/2018
• Device Catalogue Number: 80400
• Device Lot Number: 03Z1115
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/23/2016
• Initial Date FDA Received: 06/17/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 07/12/2016; 09/13/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/17/2016
• 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
• Patient Age: 00066 YR
• Patient Weight: 68