BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CHILDRENS MERCY KS CTY MO1

    MDR report key: 1172015 · Received September 18, 2008

    Report

    Report Number
    1718850-2008-00025
    Event Type
    Malfunction
    Date Received
    September 18, 2008
    Date of Event
    August 12, 2008
    Report Date
    August 19, 2008
    Manufacturer
    SORIN GROUP USA, INC.
    Product Code
    DTZ
    PMA / PMN Number
    PREAMENDMENT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT WAS RETURNED FOR EVALUATION. THEREFORE, ONE REPRESENTATIVE PACK WAS PULLED FROM INVENTORY. THREE TUBING SEGMENTS FROM THE PACK WERE PLACED INTO ROLLER PUMP RACEWAYS AND TESTED TO FAILURE. ALL THREE EXCEEDED THE RATED TIME OF USER PRIOR TO FAILING. TUBING DIMENSIONS (INNER DIAMETER, OUTER DIAMETER AND WALL THICKNESS) WERE ALSO MEASURED AND WERE WITHIN SPECIFICATIONS. UNFORTUNATELY, THE CAUSE FOR THE SPLIT TUBING FAILURE COULD NOT BE DETERMINED. THE TUBING USED IN THE RACEWAY BY THE PERFUSIONIST WAS PVC 1/4" ID X 1/16" WALL THICKNESS. THE ATTACHED HEART/LUNG INSTRUCTIONS FOR USE WARN THAT 1/16" TUBING WALL THICKNESS SHOULD NOT BE USED FOR AN ARTERIAL BLOOD PUMP HEAD APPLICATIONS AS IT IS SUSCEPTIBLE TO PREMATURE FAILURE. THE PERFUSIONIST HAS SINCE CHANGED TO 1/4" ID X 3/32" WALL, A THICKER, MORE DURABLE TUBING. NO OTHER ACTIONS ARE DEEMED NECESSARY.

    Description of Event or Problem · 1

    THE PERFUSIONIST REPORTED A TUBING SPLIT IN THE ARTERIAL ROLLER PUMP RACEWAY DURING PRIME. THE EVENT OCCURRED DURING PRIME. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CHILDRENS MERCY KS CTY MO1 CUSTOMER PERFUSION PACK DTZ SORIN GROUP USA, INC. NA 0818300017

    Patients

    Seq Age Sex Outcome Treatment
    1 NA