BEUDAMED
    FDA Adverse Event Injury Summary report: Y

    TRIMA ACCEL

    MDR report key: 10396277 · Received August 12, 2020

    Report

    Report Number
    1722028-2020-00375
    Event Type
    Injury
    Date Received
    August 12, 2020
    Date of Event
    July 15, 2020
    Report Date
    August 12, 2020
    Manufacturer
    TERUMO BCT
    Product Code
    GKT
    UDI-DI
    05020583810020
    PMA / PMN Number
    BK150321
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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.

    Additional Manufacturer Narrative · 0

    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.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING FILED TO PROVIDE ADDITIONAL INFORMATION IN B.5. INVESTIGATION IS IN PROCESS. A FOLLOW UP REPORT WILL BE PROVIDED.

    Description of Event or Problem · 0

    THE CUSTOMER DID NOT RESPOND TO MULTIPLE ATTEMPTS TO OBTAIN THE PATIENT INFORMATION OR WHETHER MEDICAL INTERVENTION WAS REQUIRED FOR THIS EVENT.

    Additional Manufacturer Narrative · 1

    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.

    Description of Event or Problem · 1

    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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    861110 TRIMA ACCEL TRIMA REFURBISHED, FINAL ASSEMBLY GKT TERUMO BCT 81002 05020583810020

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other