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

Catalog Number 80440

Device Problem Device Displays Incorrect Message (2591)

Patient Problems Hematoma (1884); Pain (1994); Injury (2348)

Event Date 01/31/2012

Event Type  Injury  

Manufacturer Narrative

Investigation: the run data file was analyzed for this event.The 'return pressure too high' alarms reported during the procedure were confirmed in the rdf.Investigation is in process.A follow-up report will be provided.

Event Description

The customer reported that a donor has filed a lawsuit claiming injury during a donation.The donor's reported injury is a frozen shoulder.During the platelet apheresis on (b)(6) 2012, approximately 12 minutes into the procedure, the customer received multiple alarms including 'return pressure too high' alarm.The operator ended the procedure without rinse back.While the operator was disconnecting the donor, a small hematoma was noted on the donor's left arm.An ice pack was applied for post care.The customer followed-up with the donor on (b)(6) 2012.The donor reported that she experienced a pain point that traveled up her arm as a result of the platelet collection.She had no bruising or rashes, and the donor's pain subsided and no additional problems were noted later that day.The disposable kit is not available for return because it was discarded by the customer.

Manufacturer Narrative

Investigation: the customer did not provide the lot number pertaining to this event,therefore a device history record (dhr) search could not be conducted for this specific incident.All lots must meet acceptance criteria before release.Root cause: this disposable was unavailable for specific root cause analysis.Per information provided by the customer, no medical intervention was administered.A definitive root cause was not determined.Possible causes include, but not limited to, poor phlebotomy technique, donor physiology or rapid return flows.

Manufacturer Narrative

Investigation: lot number was provided by the customer.A review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.Based on information provided to terumo bct, associated with the 2012 donation procedure, a small area of the donor's arm experienced hematoma, for which the donor received an ice pack as post care.Per the customer, during a follow up conversation between the customer and the donor at the time of the event, the donor did not have any bruising or rashes and any associated pain had subsided.No additional problems were noted during the follow up time frame.Per aabb technical manual, hematoma and other side effects including nerve irritation, local allergy, arterial puncture, vasovagal reactions, (among other possible reactions) are also frequent whole blood donation and are recognized risks of collecting blood products for transfusion.While hematoma is one of several known side effects associated with apheresis procedures, based on the information available from the customer and the run data file (rdf) analysis, we have no evidence that associates the alleged shoulder injury with the 2012 donation procedure.Root cause (updated): based on information provided by the customer, combined with the rdf analysis, there is no evidence that the trima product contributed to the shoulder injury alleged by the donor in 2015.

• Brand Name: TRIMA ACCEL
• Type of Device: TRIMA ACCEL ENHANCED 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: 5239546
• MDR Text Key: 31736307
• Report Number: 1722028-2015-00616
• Device Sequence Number: 1
• Product Code: GKT
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: BK110009
• 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: 11/20/2015

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: 10/01/2013
• Device Catalogue Number: 80440
• Device Lot Number: 10T1127
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/29/2015
• Initial Date FDA Received: 11/20/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 12/15/2015; 02/18/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/28/2011
• 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; Disability
• Patient Age: 51 YR
• Patient Weight: 72