BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DLP

    MDR report key: 2921436 · Received December 12, 2012

    Report

    Report Number
    2921436
    Event Type
    Malfunction
    Date Received
    December 12, 2012
    Date of Event
    December 3, 2012
    Report Date
    December 6, 2012
    Manufacturer
    MEDTRONIC
    Product Code
    DWF
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    THE PATIENT WAS ON CARDIAC BYPASS WITH 14 AND 18 FRENCH GAUGE (FR) VENOUS CANNULA. THE CENTRAL VENOUS PRESSURE (CVP) WENT FROM 5 TO 28 WHEN THE CAVAL TAPE WAS APPLIED TO THE SUPERIOR VENA CAVA (SVC) CANNULA. THE CANNULA HAD BEEN (APPARENTLY) POSITIONAL AND THE SURGEON DECIDED TO UPSIZE AND CHANGE OUT THE CANNULA. THE CVP WAS ZERO WHEN THE CAVAL TAPE WAS APPLIED TO THE NEW 16 FR SVC CANNULA. THE 14 FR CANNULA WAS FOUND TO HAVE CLOT FORMATION IN THE METAL PORTION. THE LOT OF 14 FR CANNULA MAY BE FROM THE "OLD" PRODUCTION LOT EVEN THOUGH WE SPECIFICALLY REQUESTED A "NEW" LOT LAST WEEK WHICH WAS OVERNIGHTED TO US. MEDTRONIC HAS BEEN MADE AWARE BUT HAS NOT CONFIRMED WHETHER THE LOT WAS NEW OR OLD.REPLY FROM MEDTRONIC: THEY HAVE STATED THAT THE METAL TIP ON THE CANNULA WAS OF THE NEW STYLE. UNFORTUNATELY, UPON INSPECTION THE TIP DID NOT MEET THEIR STANDARDS. THEY HAVE PULLED SAMPLES FROM 80 LOTS AND ARE IN THE PROCESS OF EVALUATING THOSE SAMPLES. ======================MANUFACTURER RESPONSE FOR DLP ANGLED METAL TIP VENOUS CANNULA, MEDTRONIC DLP (PER SITE REPORTER).======================

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DLP CATHETER, CANNULA DWF MEDTRONIC 14 FR 2102090416

    Patients

    Seq Age Sex Outcome Treatment
    1 3 YR