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

Catalog Number 80440

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/22/2017

Event Type  malfunction  

Manufacturer Narrative

Investigation: during customer follow-up, the rn stated that she contacted their medical director.The medical director stated that this incident is low risk and there was not a donor safety issue.Investigation is in process.A follow-up report will be provided.

Event Description

The customer reported that the operator did not follow the prompts in connecting the donorfor a collection procedure.The operator performed a venipuncture on the donor and clamped the donor line prior to the start of ac prime.The procedure was ended after processing 56mlof blood.Per the customer, the donor appeared to be 'okay' when he left the customer's site.The donor is reported in healthy condition.The collection set is not available for return because it was discarded by the customer.

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.The run data file (rdf) was analyzed for this event.Upon review of the rdf, no air was returned to the donor.Root cause: based on the statement provided by the customer, the operator connected the donor prior to ac prime, which suggest operator error.

• Brand Name: TRIMA ACCEL
• Type of Device: TRIMA ACCEL ENHANCED 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: 6572475
• MDR Text Key: 75521191
• Report Number: 1722028-2017-00186
• Device Sequence Number: 1
• Product Code: GKT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K162365
• 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: 05/17/2017

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: 03/01/2019
• Device Catalogue Number: 80440
• Device Lot Number: 1703231231
• Other Device ID Number: 05020583804401
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/22/2017
• Initial Date FDA Received: 05/17/2017
• Supplement Dates Manufacturer Received: 08/09/2017
• Supplement Dates FDA Received: 08/11/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/27/2017
• 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: 48 YR
• Patient Weight: 83