MAUDE Adverse Event Report: TERUMO BCT TRIMA ACCEL; TRIMA ACCEL ENHANCED PLT, PLS, RBC, AUTORBC SET

Catalog Number 80360

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

Patient Problems Thrombosis (2100); Reaction (2414)

Event Date 12/01/2016

Event Type  malfunction  

Manufacturer Narrative

Per the customer, they received multiple ¿draw pressure too low¿ alarms during the double platelet collection procedure.The customer stated that a qc testing was performed on the collected platelet units with ¿fine¿ results and the units were distributed.Per the customer, the donor contacted the customer¿s site and stated that she is unable to donate platelets and she was prescribed with blood thinners.The run data file (rdf) was analyzed for this event.Signals in the rdf did not show any unusual process variable and the trima accel system operated as intended.Investigation is in process.A follow-up report will be provided.

Event Description

The customer reported that a donor was hospitalized post platelet collection procedure.On (b)(6) 2016, the donor completed a double platelet collection procedure during the afternoon and left the customer¿s site in healthy condition.Three days post collection procedure, the donor was admitted to the hospital for blood clots in her lungs and was transferred to the intensive care unit (icu).Per the medical director at the customer¿s site, the blood clots experienced by the donor were not the results of her platelet collection procedure.The platelet collection set is not available for return because it was discarded by the customer.

Manufacturer Narrative

Investigation: a review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.Service calls were performed on the device after the incident date to address the cassette plate position alarms at power up on (b)(6) 2016, and (b)(6) 2017.Terumo bct's service technician inspected and verified that the cassette plate calibration met manufacturing specification.An auto test was successfully performed.Furthermore, terumo bct's engineering manager also reviewed the service calls and determined that the service calls were unrelated to the donor's incident.Root cause: a definitive root cause for the clots in the lungs could not be determined.The medical director had spoken to the donor and it was reported that the blood clots were not the result of the platelet donation.The donor did not tell the blood bank what caused the clots.Run data file analysis showed that the machine operated as intended during the donation.

Manufacturer Narrative

Additional information: per terumo bct's medical review, the device did not cause or contribute to this incident.

• Brand Name: TRIMA ACCEL
• Type of Device: TRIMA ACCEL ENHANCED PLT, PLS, RBC, AUTORBC SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• Manufacturer Contact: steve kern ; 10811 w. collins ave; lakewood, CO 80215 ; 3032392246
• MDR Report Key: 6196633
• MDR Text Key: 63067676
• Report Number: 1722028-2016-00661
• Device Sequence Number: 1
• Product Code: GKT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: BK150321
• 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: 12/21/2016

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: 09/01/2018
• Device Catalogue Number: 80360
• Device Lot Number: 09Z3113
• Other Device ID Number: 05020583803602
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/05/2016
• Initial Date FDA Received: 12/21/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 02/03/2017; 03/20/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/13/2016
• 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
• Patient Age: 66 YR
• Patient Weight: 91