BEUDAMED
    FDA Adverse Event Death Summary report: N

    ABVISER AUTOVALVE VALVE IAP MONITORING DEVIC

    MDR report key: 4343298 · Received December 16, 2014

    Report

    Report Number
    1049092-2014-00622
    Event Type
    Death
    Date Received
    December 16, 2014
    Date of Event
    October 9, 2014
    Report Date
    November 19, 2014
    Manufacturer
    CONVATEC, INC.
    Product Code
    FEN
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    BASED OIN THE AVAILABLE INFORMATION, THIS EVENT IS DEEMED TO BE A DEATH; HOWEVER THERE IS NO ALLEGATION THE DEATH IS DEVICE RELATED. NO FURTHER INFORMATION WAS AVAILABLE AT THE TIME OF THE REPORT. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. REPORTED TO THE FDA ON 12/16/2014.

    Description of Event or Problem · 1

    IT WAS REPORTED THE INTRA-ABDOMINAL PRESSURE MONITORING DEVICE WAS USED ON A NEWBORN PATIENT. THE PATIENT WAS REPORTEDLY SUFFERING FROM "MANY COMPLICATIONS" AND HAD BEEN PREVIOUSLY ADMITTED TO THE HOSPITAL'S INTENSIVE THERAPY UNIT. ON (B)(6) 2014, A NURSE AT THE FACILITY INFUSED SIX MILLILITERS IN THE PRESSURE MONITORING SYSTEM AND NOTED THE AUTOVALVE DID NOT ACTIVATE. THE NURSE THEN UNFUSED AN ADDITIONAL TWO MILLILITERS AND AGAIN THE AUTOVALVE DID NOT ACTIVATE. THE PATIENT REPORTEDLY EXPIRED ON (B)(6) 2014. THE DEVICE HAD BEEN IN USE FOR THIRTY-NINE DAYS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    823926 ABVISER AUTOVALVE VALVE IAP MONITORING DEVIC DEVICE, CYSTOMETRIC, HYDRAULIC FEN CONVATEC, INC. ABV301 130427

    Patients

    Seq Age Sex Outcome Treatment
    1 Death