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

Catalog Number 5804001

Device Problems Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017)

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

Event Date 03/21/2017

Event Type  malfunction  

Manufacturer Narrative

Investigation: the platelet collection set with the product bags were returned for investigation.Upon visual inspection, it was noted that fluid had circulated throughout the entire set.Severe clotting and clumping were noted throughout the set including the platelet collect bags, collect connector, lrs chamber, 4-lumen, and return reservoir filter.No clotting or clumping was observed in the return line.Visual inspection for kinks, occlusions (other than the clotting noted), missing parts, misassembly or leaks which may have contributed to the reported incident did not reveal any abnormalities.Investigation is in process.A follow-up report will be provided.

Event Description

The customer reported using saline solution instead of anticoagulant citrate dextrose solution (acda) during a platelet collection procedure.Approximately 45 minutes into the procedure,the technician noticed that the saline solution bag had been spiked instead of the acda bag.The collection was stopped and the medical director was contacted.The medical director evaluated the patient (donor) post collection procedure.No treatment was required and the patient (donor) was sent home.(b)(6).

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.Root cause: per the customer saline was used instead of anticoagulant during the procedure.

• Brand Name: TRIMA ACCEL
• Type of Device: TRIMA ACCEL PLATELET, PLASMA, RBC SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• Manufacturer Contact: steve kern ; 10810 w. collins ave; lakewood, CO 80215 ; 3032392246
• MDR Report Key: 6494319
• MDR Text Key: 73024867
• Report Number: 1722028-2017-00144
• 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
• Report Date: 04/14/2017

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: 09/01/2018
• Device Catalogue Number: 5804001
• Device Lot Number: 1609155151
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/27/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/21/2017
• Initial Date FDA Received: 04/14/2017
• Supplement Dates Manufacturer Received: 07/13/2017
• Supplement Dates FDA Received: 07/28/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/14/2016
• 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
• Treatment: NORMAL SALINE (NS) LOT NUMBER: 15D27E8N
• Patient Outcome(s): Other
• Patient Age: 23 YR
• Patient Weight: 95