MAUDE Adverse Event Report: TERUMO BCT TRIMA ACCEL; TRIMA ACCEL AUTO RBC AND PLASMA SET

Catalog Number 80520

Device Problems Kinked (1339); Incorrect, Inadequate or Imprecise Result or Readings (1535); Improper or Incorrect Procedure or Method (2017); Insufficient Flow or Under Infusion (2182); Device Displays Incorrect Message (2591)

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

Event Date 11/14/2016

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The customer initially contacted terumo bct's support specialist due to multiple alarms including 'air block' and 'level sensor' alarms during a collection procedure.Post-procedure, they noticed that the plasma collect volume was lower than expected.The plasma collect volume measured 164ml compared to the expected predicted volume of 736ml.Terumo bct's support specialist performed a calculation on the approximate anti-coagulant(ac) infusion rate and determined that an additional 83ml of ac was returned to the donor with product that was diverted back to the donor instead of the collect product bag.The customer stated that the donor did not have any issues related to this procedure.Patient (donor) full identifier: (b)64).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.According to the version 6.0 trima accel system administrator's guide, the tbv is less than the maximum allowed ac infusion rate of 1.2 ml/min/l tbv for a 52 minute procedure, and it is unlikely that an ac over-infusion occurred due to the plasma product being diverted back to the donor due to a potential plasma occlusion or air block.Root cause: a definitive root cause for the low volume and additional anticoagulant to donor could not be determined.Rdf analysis indicates that an occlusion or air block was occurring to cause the low volume.Possible causes for the air block or occlusion include, but are not limited to, a kink, obstruction or misload of the disposable set.

• Brand Name: TRIMA ACCEL
• Type of Device: TRIMA ACCEL AUTO RBC AND PLASMA SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• Manufacturer Contact: steve kern ; 10811 w collins ave; lakewood, CO 80215 ; 3032392246
• MDR Report Key: 6149706
• MDR Text Key: 62156253
• Report Number: 1722028-2016-00635
• 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: 12/06/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2016
• 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: 80520
• Device Lot Number: 09Z2221
• Other Device ID Number: 05020583805200
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/27/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/21/2016
• 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: 47 YR
• Patient Weight: 127