MAUDE Adverse Event Report: TERUMO BCT TRIMA ACCEL; TRIMA ACCEL LRS PLATELET, SAMPLER, MULTIPLASMA RBC SET

Catalog Number 82408

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems No Consequences Or Impact To Patient (2199); No Patient Involvement (2645)

Event Date 06/11/2019

Event Type  malfunction  

Manufacturer Narrative

Investigation: a review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.Corrective action: an internal capa was initiated to evaluate air in the sample bag.Investigation is in process.A follow up report will be provided.

Event Description

The customer reported that during the prime and tubing set test for a collection procedure ona trima device, they received a "pressure test error - access neg not reached" alarm and the sample bag inflated with air.Per the customer the clamps were closed according to protocol, the venipuncture was not completed and the donor was never connected.Donor identifier and age are not available at this time.The collection set is not available for return because it was discarded by the customer.

Manufacturer Narrative

This report is being filed to provide in (b)(6) qc.Cainvestigation: the system prompted the operator to verify that the white clamps on thedonor line were closed and that there was no air in the sample bag.Root cause: based on the information available, a specific root cause could not be determined.Possible causes include but are not limited to:- an operator error, where either the sample bag clamp was not closed at the system prompt orthe clamp was closed but it was skewed on the tubing allowing a portion of the tubing to allow airto pass.- a defective clamp.

Event Description

There was no donor connected for this event, therefore no donor information is reasonablyknown at the time of the event.Correction: patient gender and weight information provided in the initial mdr are no longerrelevent to this report.

Manufacturer Narrative

The report is being filed to provide corrected information in h.6.Correction: conclusion code, previously provided code (19 cause traced to user) is notapplicable for this event.

• Brand Name: TRIMA ACCEL
• Type of Device: TRIMA ACCEL LRS PLATELET, SAMPLER, MULTIPLASMA RBC SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• MDR Report Key: 8771973
• MDR Text Key: 151448357
• Report Number: 1722028-2019-00168
• Device Sequence Number: 1
• Product Code: GKT
• UDI-Device Identifier: 05020583824089
• UDI-Public: 05020583824089
• Combination Product (y/n): N
• PMA/PMN Number: BK180231
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 07/09/2019

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: 03/01/2021
• Device Catalogue Number: 82408
• Device Lot Number: 1903131230
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 06/14/2019
• Initial Date FDA Received: 07/09/2019
• Supplement Dates Manufacturer Received: 09/12/2019; 09/12/2019
• Supplement Dates FDA Received: 09/12/2019; 09/12/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Weight: 83