BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZOLL IVTM SOLEX 7CATHETER

    MDR report key: 6182772 · Received December 16, 2016

    Report

    Report Number
    3010617000-2016-00932
    Event Type
    Malfunction
    Date Received
    December 16, 2016
    Date of Event
    November 25, 2016
    Report Date
    January 24, 2017
    Manufacturer
    ZOLL CIRCULATION
    Product Code
    NCX
    UDI-DI
    00849111075305
    PMA / PMN Number
    K101987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ZOLL HAS NOT YET RECEIVED THE ZOLL CATHETER FOR INVESTIGATION. A SUPPLEMENTAL REPORT WILL BE FILED IF AND WHEN THE PRODUCT IS RETURNED AND INVESTIGATION HAS BEEN COMPLETED. MASS OF BLOOD LIKE SUBSTANCE SURROUNDING THE BALLOON WAS OBSERVED BY RN. THIS MASS COULD REPRESENT A THROMBUS MASS, WHICH DEVELOPED IN THE PATIENT IN A CRITICAL CONDITION WHO WAS ABOUT TO RECEIVE MORGUE CARE. SLOW BLOOD FLOW COULD CONTRIBUTE IN DEVELOPMENT OF SUCH A MASS. HOWEVER, RELEVANT LOCATION AND TIMING MAKE POSSIBLE CONTRIBUTION OF THE DEVICE TO THE EVENT EVEN IN PREDISPOSED PATIENT.

    Additional Manufacturer Narrative · 1

    EVALUATION OF THE RETURNED SOLEX CATHETER (LOT# 64292) CONFIRMED THE CUSTOMER REPORTED ISSUE. AN OUTER SHAFT WAS FOUND TO BE KINKED. THE CATHETER REMAINED IN A BENT POSITION AT THE KINK. PROBABLE CAUSE FOR THE CUSTOMER COMPLAINT OF DIFFICULTY REMOVING THE CATHETER WAS DUE TO EXCESSIVE FORCE CAUSING THE CATHETER TO BEND AND KINK, RESULTING IN THE RESTRICTION OF FLOW THROUGHOUT THE CATHETER. HOWEVER, THE ROOT CAUSE COULD NOT BE IDENTIFIED AS WE WERE UNABLE TO DETERMINE THE EXACT POINT IN TIME THE KINK OCCURRED. DURING MANUFACTURING, ALL SOLEX CATHETERS ARE 100% INSPECTED. ONLY UNITS THAT PASSED ARE MOVED TO THE NEXT PROCESS. EVALUATION OF THE RETURNED CATHETER FOUND THE CATHETER WAS BENT AND KINKED. BLOOD HAD ACCUMULATED /DRIED UP ON THE BALLOONS, SHAFT, LUERED TUBINGS AND INFUSION PORTS. THE CATHETER MET WITH RESISTANCE DURING FLUSHING; THUS CONFIRMING THE REPORTED COMPLAINT. HISTORICAL COMPLAINTS WERE REVIEWED FOR SERVICE INFORMATION RELATED TO THE REPORTED COMPLAINT AND THERE WERE NO PREVIOUS HISTORY OF COMPLAINTS REPORTED FOR SOLEX CATHETER LOT # 64292.

    Description of Event or Problem · 1

    ON (B)(6) 2016, THE SOLEX 7 CATHETER WAS PLACED IN THE PATIENT'S LEFT INTERNAL JUGULAR. THE REPORTING NURSE PRACTITIONER INDICATED THE SOLEX WAS PLACED AT THE 20CM MARK AND "WAS NOT DEEP ENOUGH" ON CHEST XRAY, BUT HAD GOOD FLUSH AND RETURN IN ALL PORTS. THE SOLEX WAS ADVANCED TO THE 26CM MARK AND WAS IN GOOD PLACEMENT HOWEVER WOULD NO LONGER FLUSH OR DRAW FROM THE DISTAL PORT. SOLEX WAS LEFT AT THE 26CM MARK AND DISTAL PORT WAS NOT UTILIZED. ON THE EVENING OF (B)(6) 2016, IT WAS REPORTED THAT THE ATTENDING RN HAD DIFFICULTY REMOVING THE SOLEX 7 CATHETER AFTER THE PATIENT PASSED AWAY AT AN UNSPECIFIED TIME THAT DAY. ACCORDING TO THE RN THE CATHETER WAS PARTIALLY REMOVED AND THEN REMAINED STAGNANT IN THE VESSEL. THE RN WAS UNABLE TO PUSH IN OR PULL THE CATHETER OUT AT THIS TIME. THE RN WAS INSTRUCTED BY THE SITE'S ZOLL CLINICAL FIELD SPECIALIST, TO UTILIZE THE SYRINGE IN THE START-UP KIT TO ASPIRATE ALL SALINE OUT OF THE BALLOONS. DESPITE FOLLOWING THE INSTRUCTIONS, THE RN WAS STILL UNABLE TO PULL OUT THE SOLEX 7 CATHETER. A MORE EXPERIENCE RN ATTEMPTED; HOWEVER, SINCE THE BODY WAS BEING PREPARED FOR MORGUE CARE, THE SOLEX 7 WAS PULLED AGGRESSIVELY OUT OF THE VEIN. THE RN OBSERVED A MASS OF BLOOD LIKE SUBSTANCE SURROUNDING THE BALLOON. PATIENT HAD ALREADY EXPIRED AT THE TIME THE REPORTED ISSUE OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    830980 ZOLL IVTM SOLEX 7CATHETER CENTRAL VENOUS CATHETER NCX ZOLL CIRCULATION SL-2593 UNKNOWN 00849111075305

    Patients

    Seq Age Sex Outcome Treatment
    1