BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MITEK FMS DUO PUMP +

    MDR report key: 3584096 · Received January 21, 2014

    Report

    Report Number
    1221934-2014-00030
    Event Type
    Injury
    Date Received
    January 21, 2014
    Report Date
    January 15, 2014
    Manufacturer
    DEPUY MITEK
    Product Code
    HRX
    PMA / PMN Number
    K954465
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    OUR PATIENT SAFETY DEPARTMENT DISCOVERED THIS PUBLISHED WHITE PAPER DETAILING A HISTORICAL EVENT IN WHICH SOME MITEK DEVICES WERE IMPLICATED. WE CANNOT CONFIRM THAT THIS ISSUE HAD BEEN PREVIOUSLY REPORTED TO MITEK, SO WE ARE FILING AN ADVERSE EVENT REPORT TO DOCUMENT THE EXPERIENCE DESCRIBED IN THE ARTICLE. AT THIS POINT IN TIME, NO FURTHER ACTION IS WARRANTED. HOWEVER, THIS FILE WILL REMAIN RECEPTIVE TO ANY POTENTIAL FORTHCOMING INFORMATION RECEIVED THAT IS PERTINENT AND GERMANE TO THIS ISSUE. ALSO, MITEK WILL CONTINUE TO TRACK ANY RELATED COMPLAINTS WITHIN THIS DEVICE FAMILY AS A MEANS OF MONITORING THE EXTENT WITH WHICH THIS COMPLAINT IS OBSERVED IN THE FIELD.

    Description of Event or Problem · 1

    THE FOLLOWING ISSUE WAS DISCOVERED VIA A PUBLISHED INDIVIDUAL CASE REPORT BY THE MITEK SAFETY OFFICER: INDIVIDUAL CASE REPORTS (COMPLICATIONS). AUTHOR: CAVAIGNAC (2013) FRANCE. REFERENCE: CAVAIGNAC E, PAILHÉ R, REINA N, CHIRON P, AND LAFFOSSE JM. MASSIVE PROXIMAL EXTRAVASATION AS A COMPLICATION DURING ARTHROSCOPIC ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION. KNEE SURG RELAT RES 2013;25(2):84-87. ADDRESS: ETIENNE CAVAIGNAC, MD. INSTITUT LOCOMOTEUR - SERVICE DE CHIRURGIE ORTHOPÉDIQUE ET TRAUMATOLOGIQUE, CHU RANGUEIL, 1, AVENUE JEAN POULHÈS TSA 50032, 31059 TOULOUSE CEDEX 9, FRANCE. TEL: +33-6007342595, FAX: +33-561322232. E-MAIL: [email protected]. PATIENTS GROUP: N/A. PATIENT CHARACTERISTICS: AGE: (B)(6). GENDER: MALE. INDEX OPERATION: ACL REPAIR (OLD ACL TEAR + POSTERIOR HORN AND MEDIAL MENISCUS TEAR > FEMORAL SHAFT FRACTURE). DEVICES: FMS DUO+ TIME OF COMPLICATION: DURING OPERATION (OPERATION ENDED AFTER 105 MIN. AND 15 LITERS OF IRRIGATION FLUID.) TYPE OF COMPLICATION: EXTRAVASATION (THIGH, RIGHT ILIAC FOSSA, PERINEUM, AND SCROTUM). - - JOINT: KNEE. DEVICE: FMS DUO+ (PRESSURE VALUE ERROR). SUTURE: -- OTHER DEVICES: - SIGNS AND SYMPTOMS: SWELLING OF THE THIGH, RIGHT ILIAC FOSSA, PERINEUM AND SCOTUM. TISSUE DAMAGE: NO COMPARTMENT SYNDROME, PULSES WERE NORMAL, NO SENSORY OR MOTOR DISTURBANCES, BLOOD PRESSURE NORMAL, NO SIGN OF BLOOD LOSS. IMAGING STUDIES: ABDOMINAL AND PELVIC ULTRASOUND: EFFUSION OF THE SUBPERITONEAL SPACE AND SCROTUM. REOPERATION (RELATED/UNRELATED): ACL REPAIR USING THE TUNNELS FROM THE FIRST SURGERY (RELATED). MEDICAL TREATMENT: FUROSEMIDE. F/U TIME: 5 YRS. IMAGING STUDIES: - OBJECTIVE OUTCOMES: NO SEQUELAE. FUNCTIONAL OUTCOMES: - SUBJECTIVE OUTCOMES:

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    50402 MITEK FMS DUO PUMP + FLUID MANAGEMENT SYSTEM HRX DEPUY MITEK NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Required Intervention