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

Catalog Number 82400

Device Problems Improper or Incorrect Procedure or Method (2017); Device Displays Incorrect Message (2591); Inadequate User Interface (2958)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/05/2017

Event Type  malfunction  

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.Investigation is in process.A follow-up report will be provided.

Event Description

The customer reported that during a platelet donation procedure, they received multiple alarms including, 'centrifuge high pressure' alarms.The operator stopped the procedure.While the operator was disconnecting the donor, the operator noticed that the sample bag was placed under the donors arm and the white pinch clamp was inadvertently left open.Per the customer,the platelet product was discarded and no air was returned to the donor.Patient identifier is not available at this time.The platelet collection set is not available for return because it was discarded by the customer.

Manufacturer Narrative

Per the customer, the donor has donated platelets since this event without any problems.The run data file (rdf) was analyzed for this event.The rdf analysis confirmed that the centrifuge pressure high alarm was received during a draw cycle.If pressure was placed on the sample bag during a draw cycle, the air from the sample pouch would be pulled into the centrifuge.This could result in an air block in the connector creating a centrifuge pressure high alarm.Any air in the channel/centrifuge is directed into the vent bag through the reservoir with no safety issues to the donor.Root cause: air to donor: based on the clinical findings, the root cause of the potential air to donor event was related to operator error.The customer did not follow the screen prompts that instruct the sample bag clamp to be closed and line to be hermetically sealed prior to starting the first draw.The error went unnoticed until the machine alarmed due to the sample bag being placed under the donor's arm.This positioning of the bag likely attributed to air from the sample bag being pushed into the disposable set during a draw cycle.

Event Description

Due to eu personal data protection laws, the patient (donor) information is not available from the customer.Patient's gender and weight were obtained from the run data file (rdf).

• Brand Name: TRIMA ACCEL
• Type of Device: TRIMA ACCEL PLATELET, PLASMA, RBC ISBT SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• Manufacturer Contact: steve kern ; 10810 w. collins ave; lakewood, CO 80215 ; 3032392246
• MDR Report Key: 6377302
• MDR Text Key: 69364720
• Report Number: 1722028-2017-00055
• Device Sequence Number: 1
• Product Code: GKT
• Combination Product (y/n): N
• Reporter Country Code: SE
• PMA/PMN Number: BK150321
• 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
• Report Date: 03/03/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/01/2018
• Device Catalogue Number: 82400
• Device Lot Number: 06Z1107
• Other Device ID Number: 05020583824003
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/09/2017
• Initial Date FDA Received: 03/03/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/24/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/07/2016
• 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): Other
• Patient Weight: 95