MAUDE Adverse Event Report: TERUMO BCT TRIMA ACCEL; TRIMA REFURBISHED, FINAL ASSEMBLY

Model Number 81002

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Injury (2348)

Event Date 07/15/2020

Event Type  Injury  

Manufacturer Narrative

Investigation: a terumo bct service technician checked out the machine at the customer site.The equipment was checked to rule out failure and another procedure was performed with another donor.Per the service technician the machine worked properly.Investigation is in process.A follow-up report will be provided.

Event Description

The customer reported a venipuncture failure in which there was a patient (donor) injury.Details of the donor injury or if any medical intervention was necessary are not available at this time.Per the customer, possible causes of the venipuncture failure were a very fine vein, the donor moved, or a poorly performed venipuncture.Patient (donor) information is not available at this time.

Manufacturer Narrative

This report is being filed to provide additional information.Investigation: one year of service history was reviewed for this device with no issues related to the reported condition identified.The device serial number history report indicates no further related issues have been reported for this device.The customer stated that another procedure was performed on the trima with another donor and there were no issues.Investigation is in process.A follow up report will be provided.

Manufacturer Narrative

This report is being filed to provide additional information in b.5.Investigation is in process.A follow up report will be provided.

Event Description

The customer did not respond to multiple attempts to obtain the patient information or whether medical intervention was required for this event.

Manufacturer Narrative

This report is being filed to provide additional information in h10.Investigation: according to a three year retrospective study of platelet donations between 2014 and 2017, the incidence of adverse events was 4.2%, of which 91.3% were mild and 8.7% were severe.Vascular injuries, including bleeding, hematomas, pain and discoloration at the insertion site, comprised 65.3% of the total number, are typically mild, and are more likely to be prevalent among donors with lower body mass index (bmi).Vascular adverse events can be attributed to vein conditions, stability of the underlying subcutaneous tissue, or arm muscularity.Vascular injuries can also result from traumatic needle insertion and/or be aggravated by the anticoagulant solution infused into the system.The practitioner's manual dexterity to perform venipuncture may also have a confounding effect.[almutairi h et al.Incidence and severity of adverse events among platelet donors.Medicine (2020) 99:52.] root cause: a definitive root cause could not be determined.Possible causes include but are not limited to: - patient physiology.- poor phlebotomy technique causing the needle to unintentionally enter the tissue surrounding the blood vessel.- dislodgement of the needle from the vein due to arm movement, a poorly secured needle, or an inadequate choice of venous site to puncture.An unidentified disposable set defect at the aps retainer ring leading to undetected high pressure.Debris at the aps sensor or improper physical coupling leading to undetected high pressure.

• Brand Name: TRIMA ACCEL
• Type of Device: TRIMA REFURBISHED, FINAL ASSEMBLY
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• Manufacturer Contact: scot hilden ; 10810 w. collins ave; lakewood, CO 80215 ; 3032314970
• MDR Report Key: 10396277
• MDR Text Key: 202695350
• Report Number: 1722028-2020-00375
• Device Sequence Number: 1
• Product Code: GKT
• UDI-Device Identifier: 05020583810020
• UDI-Public: 05020583810020
• Combination Product (y/n): N
• PMA/PMN Number: BK150321
• Number of Events Reported: 1
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 08/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 81002
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 07/21/2020
• Initial Date FDA Received: 08/12/2020
• Supplement Dates Manufacturer Received: 11/17/2020; 03/22/2021; 11/18/2021
• Supplement Dates FDA Received: 12/02/2020; 03/22/2021; 12/08/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/11/2016
• 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