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

Catalog Number 80400

Device Problems Break (1069); Improper or Incorrect Procedure or Method (2017)

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

Event Date 07/28/2016

Event Type  malfunction  

Manufacturer Narrative

Investigation is in progress.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.At 42 minutes into the procedure, it was noticed the saline solution bag had been spiked instead of the acda bag.The collection was stopped immediately and no rinseback was given.The donor was kept at the collection site and the medical director was contacted.The medical director gave instructions to the donor on what signs and symptoms the donor should look for, and to call 911 if any occurred.The donor was given fluids and snacks at the collection site.The customer stated the donor is fine and no medical intervention was required for this event.During a follow-up with the donor from the customer later that day, the donor stated he felt well.The disposable set is not available for return, because it was discarded by the customer.

Manufacturer Narrative

Investigation: the disposable set was unavailable for return.A review of the procedure confirms that the run duration was 42 minutes and was not ended prior to first return cycle.A review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.Root cause: based on the customer's report, the root cause for the incident is that the user spiked saline instead of acda.Correction: terumo bct has followed up with this customer to provide feedback on the reported condition.

• 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: 5890274
• MDR Text Key: 53669232
• Report Number: 1722028-2016-00464
• 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: 08/19/2016

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: 80400
• Device Lot Number: 06Z3120
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/28/2016
• Initial Date FDA Received: 08/19/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 09/13/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/21/2016
• 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 Age: 41 YR
• Patient Weight: 86