BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSION PULSIOCATH THERMODILUTION CATHETERS

    MDR report key: 4994840 · Received July 31, 2015

    Report

    Report Number
    3003263092-2015-00025
    Event Type
    Injury
    Date Received
    July 31, 2015
    Date of Event
    February 9, 2015
    Report Date
    February 9, 2015
    Manufacturer
    PULSION MEDICAL SYSTEMS SE
    Product Code
    KRB
    PMA / PMN Number
    K072364
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    1

    Narratives

    Additional Manufacturer Narrative · 1

    ACCORDING TO REC'D INFORMATION THE PICCO CATHETER WAS DISCARDED. THROMBOSIS IS CONSIDERED AS A KNOWN COMPLICATION OF ARTERIAL CANNULATION BUT SINCE THE REPORTED CATHETER WAS NOT RETURNED FOR INVESTIGATION IT IS NOT POSSIBLE TO CONFIRM IF THERE WAS A MALFUNCTION OR ANY DEVIATION FROM THE SPEC. PLEASE NOTE, THIS EVENT IS BEING FILED AS A RETROSPECTIVE MDR AS A RESULT OF A REVIEW OF OUR COMPLAINT DATABASE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PICCO CATHETER WAS PLACED IN THE BRACHIAL ARTERY OF A PATIENT BEFORE HIPEC (HYPERTHERMIC INTRAPERITONEAL CHEMOTHERAPY) PROCEDURE. THE CATHETER PLACEMENT WAS NORMAL WITHOUT ANY PROBLEMS AND NO SIGNS OF BAD PERFUSION WERE NOTICED AFTER THE OPERATION. AFTER 3 HOURS IN ICU THE PATIENT STARTED TO COMPLAIN ABOUT PAIN IN THE LEFT ARM AND HAND. THE PICCO CATHETER WAS REMOVED. AFTER INITIAL IMPROVEMENT THE SITUATION DETERIORATED ON THE NEXT DAY AND A THROMBECTOMY WAS NEEDED. MFR REFERENCE #: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    502218 PULSION PULSIOCATH THERMODILUTION CATHETERS KRB PULSION MEDICAL SYSTEMS SE

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Required Intervention