BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSION PULSIOCATH THERMODILUTION CATHETERS

    MDR report key: 7432222 · Received April 16, 2018

    Report

    Report Number
    3003263092-2018-00003
    Event Type
    Injury
    Date Received
    April 16, 2018
    Date of Event
    February 6, 2018
    Report Date
    June 7, 2018
    Manufacturer
    PULSION MEDICAL SYSTEMS SE
    Product Code
    KRB
    PMA / PMN Number
    K072364
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    HE PRODUCT WAS DISCARDED BY THE CUSTOMER. FURTHER INFORMATION SURROUNDING THE EVENT HAS BEEN REQUESTED AND INVESTIGATION IS ONGOING. A SUPPLEMENTAL MEDWATCH REPORT WILL BE SENT WHEN THE INVESTIGATION IS COMPLETED. PLEASE NOTE, GETINGE USA SALES, LLC(IMPORTER) IS SUBMITTING THE REPORT ON BEHALF OF PULSION MEDICAL SYSTEMS SE (EXEMPTION NUMBER E2018007). CONTACT: PEDRO CRUZ 45 BARBOUR POND ROAD WAYNE, NEW JERSEY 07470

    Additional Manufacturer Narrative · 0

    THE INVOLVED CATHETER WAS NOT AVAILABLE FOR INVESTIGATION AS IT WAS DISCARDED BY THE USER IN THE HOSPITAL. AN INVESTIGATION OF A RETAIN SAMPLE OF THE SAME BATCH AND A DHR REVIEW COULD NOT BE PERFORMED AS THE BATCH WAS NOT PROVIDED DESPITE SEVERAL REQUEST. A SIMILAR CATHETER WITH GREATER LENGTH WAS TESTED IN JUNE 2016 FOR ITS HAEMOCOMPATIBILITY. THE RESULTS SHOW THAT THE REQUIREMENTS FOR THE INTERACTION OF THE TEST ITEM WITH BLOOD ACCORDING TO ISO 10993-4 ARE FULFILLED. THE ISSUE IS MONITORED ON THE MARKET. THE RATE OF COMPLAINTS ABOUT A THROMBOSIS IN ASSOCIATION WITH A PICCO CATHETER KNOWN TO US IS FAR BELOW THE PUBLISHED AVERAGE OF COMPLICATIONS WITH ARTERIAL CATHETERS. ON THE BASIS OF THE OVERALL CIRCUMSTANCES AND THE INVESTIGATIONS OF SIMILAR COMPLAINTS THE INCIDENT IS SEEN AS A KNOWN COMPLICATION OF ARTERIAL CANNULATION. THE INSTRUCTIONS FOR USE (IFU) HAVE SEVERAL INDICATIONS ABOUT THE RISK OF THROMBOSIS. (B)(4). EXEMPTION #: E2018007. (B)(4).

    Description of Event or Problem · 0

    A PICCO CATHETER (4F16CM) WAS INSERTED IN A PATIENT, PATIENT UNDERWENT A DEBULKING LAPAROTOMY WITH HIPEC. POST-OPERATIVE A THROMBOSIS OF THE ARTERIA POPLITEA (CATHETER INSERTION SITE) WAS DETECTED. A FASCIOTOMY (SURGICAL INTERVENTION) WAS REQUIRED. (B)(4).

    Description of Event or Problem · 0

    MANUFACTURER REFERENCE #: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    275411 PULSION PULSIOCATH THERMODILUTION CATHETERS PROBE, THERMODILUTION KRB PULSION MEDICAL SYSTEMS SE

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention