BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSION PULSIOCATH THERMODILUTION CATHETERS

    MDR report key: 8503823 · Received April 11, 2019

    Report

    Report Number
    3003263092-2019-00004
    Event Type
    Malfunction
    Date Received
    April 11, 2019
    Date of Event
    January 9, 2019
    Report Date
    June 12, 2019
    Manufacturer
    PULSION MEDICAL SYSTEMS SE
    Product Code
    KRB
    PMA / PMN Number
    K171620
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE CONCERNED PRODUCT WAS DISCARDED BY THE USER. A RETAIN SAMPLE OF THE SAME BATCH WAS INVESTIGATED BUT NO NON-CONFORMITIES COULD BE DETECTED DURING VISUAL AND FUNCTIONAL TESTING. A REVIEW OF THE DHR DID NOT REVEAL ANY NON-CONFORMITIES RELEVANT TO THE REPORTED ISSUE. NO FURTHER COMPLAINTS WERE REPORTED FOR THIS BATCH. SINCE NO PRODUCT HAS BEEN RETURNED, THE CONCERNED PRODUCT COULD NOT BE INVESTIGATED. BUT ON THE BASIS OF THE ISSUE DESCRIPTION, EXPERIENCE AND INVESTIGATION RESULTS OF SIMILAR COMPLAINTS IT IS CONSIDERED AS VERY LIKELY THAT AN USER ERROR OCCURRED BY APPLYING EXCESSIVE FORCE DURING REMOVAL OF THE GUIDE WIRE FROM THE PATIENT. AS THE IFU STATES: ¿USE OF EXCESSIVE FORCE MAY TEAR OFF THE GUIDE WIRE. THEREFORE, GUIDE WIRE AND CATHETER ARE TO BE REMOVED SIMULTANEOUSLY.¿ PLEASE NOTE, GETINGE USA SALES, LLC(IMPORTER) IS SUBMITTING THE REPORT ON BEHALF OF PULSION MEDICAL SYSTEMS SE (EXEMPTION NUMBER E2018007). CONTACT: (B)(6), 45 BARBOUR POND ROAD, WAYNE, NEW JERSEY 07470.

    Additional Manufacturer Narrative · 0

    ADDED COMPLAINT #: (B)(4) WHICH WAS MISTAKENLY NOT POPULATED IN SECTION B5 OF THE INITIAL REPORT. PLEASE NOTE, GETINGE USA SALES, LLC(IMPORTER) IS SUBMITTING THE REPORT ON BEHALF OF PULSION MEDICAL SYSTEMS SE (EXEMPTION NUMBER E2018007). CONTACT: (B)(6), 45 BARBOUR POND ROAD WAYNE, NEW JERSEY 07470.

    Additional Manufacturer Narrative · 0

    FURTHER INFORMATION HAS BEEN REQUESTED AND INVESTIGATION IS ONGOING. A SUPPLEMENTAL MEDWATCH REPORT WILL BE SENT WHEN THE INVESTIGATION IS COMPLETED. EXEMPTION NUMBER E2018007 (B)(4).

    Description of Event or Problem · 0

    MANUFACTURER REFERENCE#: (B)(4).

    Description of Event or Problem · 0

    MANUFACTURER REFERENCE#: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AFTER CATHETER INSERTION, RESISTANCE WAS MET WHEN INTENDING TO REMOVE THE GUIDEWIRE. A PORTION OF GUIDEWIRE WAS FOUND BROKEN INSIDE THE CATHETER AFTER REMOVING THE GUIDEWIRE ALONG WITH THE CATHETER. NO PARTS REMAINED IN PATIENT; NO HARM OR CLINICAL CONSEQUENCES OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    298425 PULSION PULSIOCATH THERMODILUTION CATHETERS PROBE, THERMODILUTION KRB PULSION MEDICAL SYSTEMS SE 619506

    Patients

    Seq Age Sex Outcome Treatment
    1