BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VC10 PUMP, 115V

    MDR report key: 7153069 · Received December 28, 2017

    Report

    Report Number
    2951238-2017-00791
    Event Type
    Injury
    Date Received
    December 28, 2017
    Date of Event
    December 7, 2017
    Report Date
    August 27, 2018
    Manufacturer
    GYRUS ACMI, INC
    Product Code
    HHI
    PMA / PMN Number
    PK030935
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED TO OLYMPUS FOR EVALUATION. THE EXACT CAUSE OF THE REPORTED EVENT CANNOT BE DETERMINE; HOWEVER, BASED ON THE REPORTED EVENT USER ERROR CANNOT BE RULED OUT AS A CONTRIBUTORY FACTOR. THE INSTRUCTION MANUAL PROVIDES THE USER SEVERAL WARNINGS TO MITIGATE PATIENT INJURY. ¿STUDY THIS MANUAL AND OTHER LABELING THOROUGHLY FOR SAFE HANDLING AND STORAGE. MISUSE OF INSTRUMENTS CAN CAUSE INJURY TO THE PATIENT AND COULD HAVE AN ADVERSE EFFECT ON THE PROCEDURE BEING PERFORMED. THE SLIDING RING ON THE HANDLE MAY BE USED TO CONTROL THE VACUUM. IF THE CANNULA ADHERES TO THE UTERINE WALL OR BECOMES CLOGGED, RELEASE THE SUCTION BY MOVING THE SLIDING RING FROM THE CLOSED POSITION TO THE OPEN POSITION TO DECREASE THE VACUUM PRIOR TO REMOVAL OF THE CANNULA. FOR FOOT PEDAL OPERATION, CONFIRM THAT THE FOOT PEDAL IS PROPERLY ATTACHED. DO NOT APPLY EXCESSIVE FORCE WHILE USING THE CANNULAS AND F-SETS. EXCESSIVE PUSHING, BENDING, OR PULLING COULD RESULT IN INJURY TO THE PATIENT AND/OR BREAKAGE OF THE DEVICE.¿

    Additional Manufacturer Narrative · 1

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE ADDITIONAL INFORMATION FROM THE ORIGINAL EQUIPMENT MANUFACTURER (OEM). THE OEM PERFORMED A REVIEW OF THE DEVICE HISTORY RECORD (DHR) AND FOUND NO ANOMALIES DURING THE MANUFACTURING OF THE SUBJECT DEVICE AND SERIAL NUMBER.

    Description of Event or Problem · 1

    THE USER FACILITY INFORMED OLYMPUS THAT DURING A SUCTION DILATION AND EVACUATION (D&E PROCEDURE, THE END USER RELEASED THE FOOTSWITCH BUT THE VC-10 SUCTION DID NOT STOP AND THE PRESSURE INCREASED RESULTING IN THE PATIENT SUSTAINING BLOOD LOSS. THE PATIENT WAS ADMINISTERED MULTIPLE BLOOD TRANSFUSIONS. THE INTENDED PROCEDURE WAS COMPLETED WITH A SIMILAR DEVICE. THE PATIENT WAS ADMITTED TO THE HOSPITAL. IN ADDITION, THE USER FACILITY¿S TEAM LEAD REPORTED THAT IT IS BELIEVED THAT THE TUBING TO THE SUCTION WAS SET UP IMPROPERLY AND ATTRIBUTED TO THE REPORTED EVENT. THE END USER INSPECTED THE FLUID OVERFLOW PROTECTION/SAFETY TRAP COLLECTION SYSTEM POST PROCEDURE AND FOUND THAT BOTH CANISTERS WERE FULL OF FLUID & TISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    930651 VC10 PUMP, 115V VC10 PUMP HHI GYRUS ACMI, INC VC-10

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R