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

Catalog Number 80400

Device Problems Air Leak (1008); Improper or Incorrect Procedure or Method (2017); Device Operates Differently Than Expected (2913)

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

Event Date 10/17/2016

Event Type  malfunction  

Manufacturer Narrative

Investigation: the customer stated that the collection set failed during tubing set test.The set was retested and passed the second time.A trima collection set was returned for investigation.Upon visual inspection, it was noted prime fluid had circulated through the inlet coil and inlet pump header tube.No fluid observed in the loop, channel, remainder of cassette, or return reservoir.The following clamps were closed upon receipt of the set: white pinch clamp on sample bag line, white pinch clamp on donor line, blue pinch clamp on donor line.It was also noted that a small deviation in the tubing alignment was observed in the blue pinch clamp on the donor line.The tubing in white pinch clamp going to the sample appeared to be aligned properly.A small amount of air was observed in the sample bag.Visual inspection for kinks, occlusions, 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 that while performing a phlebotomy on the donor for a collection procedure, the operator noted the sample bag had filled with air.Patient's (donor) full identifier: (b)(6).The customer declined to provide patient's weight.

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

Manufacturer Narrative

Root cause: root cause remains undetermined at this time.Possible causes include but are not limited to: failure to close the white clamp on the sample bag line, or the white clamp on the sample bag did not properly occlude the tubing during the initial pressure test.Corrective action: an internal capa has been initiated to evaluate reports of air in sample bag.

Manufacturer Narrative

This report is being filed to provide additional information in describe event or problem, evaluation codes, and additional mfr narrative.Additional investigation: terumo bct technical service reviewed an internal report and confirmed that the 'start draw' button for the procedure was never pressed and there were 3 pressure test errors generated.Updated root cause: root cause remains undetermined at this time.Possible causes include but are not limited to: failure to close the white clamp on the sample bag line, or the white clamp on the sample bag did not properly occlude the tubing during the initial pressure test.

Event Description

During customer follow-up, the customer stated that no donor was connected at the time of the event.The information initially provided by the customer was for the intended donor.

• 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 ; 10811 w. collins ave; lakewood, CO 80215 ; 3032392246
• MDR Report Key: 6092580
• MDR Text Key: 60083545
• Report Number: 1722028-2016-00603
• 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,Followup,Followup
• Report Date: 11/10/2016

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: 09/01/2018
• Device Catalogue Number: 80400
• Device Lot Number: 09Z3209
• Other Device ID Number: 05020583804005
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/20/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/17/2016
• Initial Date FDA Received: 11/10/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 12/02/2016; 12/20/2016; 01/13/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/13/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 69 YR
• Patient Weight: 98