BEUDAMED
    FDA Adverse Event Other Summary report: N

    CUSTOM PERFUSION PACK

    MDR report key: 2820879 · Received October 30, 2012

    Report

    Report Number
    1718850-2012-01036
    Event Type
    Other
    Date Received
    October 30, 2012
    Date of Event
    August 31, 2012
    Report Date
    October 3, 2012
    Manufacturer
    SORIN GROUP ITALIA
    Product Code
    DTZ
    PMA / PMN Number
    PREAMENDMENT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT IDENTIFIER WAS NOT PROVIDED. SORIN GROUP (B)(4) MANUFACTURES THE D901: LILLIPUT 1 NEW BORN HOLLOW FIBER OXYGENATOR WHICH IS A COMPONENT OF THE CUSTOM PERFUSION PACK C21512. THE 510(K) NUMBER OF THE LILIPUT 1 NEW BORN HOLLOW FIBER OXYGENATOR IS K953835. THE INCIDENT OCCURRED IN (B)(6). THIS MEDWATCH IS BEING FILED ON BEHALF OF SORIN GROUP (B)(4). SORIN RECEIVED A REPORT THAT DURING A PROCEDURE, THERE WAS A BLOOD LEAK FROM THE MEMBRANE OF THE OXYGENATOR AND BLOOD WAS SEEN EXITING FROM THE GAS OUTLET. THE OXYGENATOR WAS CHANGED OUT. PUMP TIME WAS PROLONGED DUE TO THE INCIDENT. BLOOD PRODUCTS WERE ADMINISTERED TO THE PATIENT. THERE WERE NO PATIENT CONSEQUENCES. IT WAS REPORTED BY THE HOSPITAL THAT THE OXYGENATOR IN QUESTION WAS NOT AVAILABLE FOR EVALUATION. WITHOUT THE UNIT AVAILABLE FOR ANALYSIS, THE ISSUE COULD NOT BE CONFIRMED. DURING TESTING OF SIMILAR UNITS AVAILABLE FOR INVESTIGATION, IT WAS POSSIBLE TO REPRODUCE THE DEFECT IN WHICH LEAKS WERE OBSERVED FROM FIBERS ON THE EXTERNAL LAYERS OF THE MEMBRANE BUNDLE. SORIN GROUP (B)(4) STATED THAT THE DEFECTIVE FIBERS WERE DUE TO MECHANICAL ISSUES OCCURRING DURING THE ASSEMBLY PROCESS AND THAT THE THERMAL AND MECHANICAL STRESSES THAT OCCURRED DURING STERILIZATION, TRANSPORT AND USE ENHANCED THE FRAGILITY OF THE FIBER CAUSING A LEAK. A CAPA WAS IMPLEMENTED AND CORRECTIVE ACTIONS HAVE BEEN INTRODUCED TO IMPROVE THE MANUFACTURING PROCESS. THE OXYGENATOR WAS MANUFACTURED BEFORE THE CORRECTIVE ACTIONS WERE INTRODUCED. NO FURTHER ACTION IS DEEMED NECESSARY.

    Description of Event or Problem · 1

    SORIN GROUP RECEIVED A REPORT THAT DURING A PROCEDURE, THERE WAS A BLOOD LEAK FROM THE MEMBRANE OF THE OXYGENATOR AND BLOOD WAS SEEN EXITING FROM THE GAS OUTLET. THE OXYGENATOR WAS CHANGED OUT. PUMP TIME WAS PROLONGED DUE TO THE INCIDENT. BLOOD PRODUCTS WERE ADMINISTERED TO THE PATIENT. THERE WERE NO PATIENT CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CUSTOM PERFUSION PACK PERFUSION TUBING SYSTEM DTZ SORIN GROUP ITALIA NA 1102230026

    Patients

    Seq Age Sex Outcome Treatment
    1 6 MO Required Intervention