BEUDAMED
    FDA Adverse Event Other Summary report: N

    APEX HP M ADULT HOLLOW FIBER MEMBRANE OXYGENATOR

    MDR report key: 2497885 · Received March 6, 2012

    Report

    Report Number
    1718850-2012-00017
    Event Type
    Other
    Date Received
    March 6, 2012
    Date of Event
    January 23, 2012
    Report Date
    February 7, 2012
    Manufacturer
    SORIN GROUP ITALIA
    Product Code
    DTZ
    PMA / PMN Number
    K092895
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    SORIN GROUP (B)(4) MANUFACTURES THE APEX HP M ADULT HOLLOW FIBER MEMBRANE OXYGENATOR. THE INCIDENT OCCURRED IN (B)(6). THIS MEDWATCH IS BEING FILED ON BEHALF OF SORIN GROUP (B)(4). SORIN GROUP RECEIVED A REPORT OF A DROP IN FLOW DURING A PROCEDURE. IT WAS REPORTED THAT THE FLOW WAS NORMAL AT THE START OF THE PROCEDURE BUT BEGAN TO DROP AFTER COOLING. THE PUMP AND THE PUMP CONSOLE WERE CHANGED OUT BUT THIS DID NOT RESOLVE THE ISSUE. THE OXYGENATOR WAS THEN CHANGED OUT AND THE CASE WAS COMPLETED WITHOUT INJURY TO THE PATIENT. THE PERFUSIONIST STATED THAT A SORIN GROUP FIELD SERVICE REPRESENTATIVE WENT TO THE FACILITY TO EVALUATE THE HEART LUNG MACHINE THE FOLLOWING DAY AND NO PROBLEMS WERE FOUND. SORIN GROUP ALSO RECEIVED USER MEDWATCH #(B)(4) WHICH STATED IT WAS LATER DETERMINED BY THE HOSPITAL STAFF THAT THE OXYGENATOR MAY HAVE CAUSED THE DECREASE IN FLOW. THE OXYGENATOR AND TUBING CIRCUIT WERE RETURNED TO SORIN GROUP FOR EVALUATION. UPON OPENING THE BOX, BLOODY FLUID WAS FOUND THROUGHOUT THE PACKAGE INCLUDING ON THE OUTSIDE OF THE OUTER BOX. INSPECTION OF THE CONTENTS FOUND THAT THE PRODUCT WAS NOT DRAINED PRIOR TO SHIPMENT, AND HAD NOT BEEN PACKAGED IN A WAY THAT COULD CONTAIN LIQUIDS WHICH LED TO THE CONTAMINATION OF THE ENTIRE PACKAGE. NO DEFECTS COULD BE SEEN DURING VISUAL INSPECTION SO THE RETURNED PRODUCTS WERE RINSED AND DRIED IN PREPARATION FOR PERFORMANCE TESTING. THE DAY FOLLOWING THE RECEIPT OF THE RETURNED PRODUCT, AN E-MAIL WAS RECEIVED FROM THE FACILITY INDICATING THAT THIS WAS A (B)(6) PATIENT. NO FURTHER TESTING WAS CONDUCTED ON THE CONTAMINATED PRODUCT DUE TO RISK OF INFECTION AND COMPANY POLICY. THE SORIN GROUP HEART LUNG PERFUSION PACK INSTRUCTION FOR USE STATE, "IF THE PRODUCT HAS BEEN IN CONTACT WITH BLOOD OR BODY FLUIDS, IT MUST BE THROUGHLY CLEANED AND DISINFECTED BEFORE PACKAGING", AND "IT IS THE RESPONSIBILITY OF THE HEALTH CARE INSTITUTION TO ADEQUATELY PREPARE AND IDENTIFY PRODUCT FOR RETURN SHIPMENT. DO NOT RETURN PRODUCTS THAT HAVE BEEN EXPOSED TO (B)(6)."

    Description of Event or Problem · 1

    SORIN GROUP RECEIVED A REPORT OF A DROP IN FLOW DURING A PROCEDURE. IT WAS REPORTED THAT THE FLOW WAS NORMAL AT THE START OF THE PROCEDURE BUT BEGAN TO DROP AFTER COOLING. THE PUMP AND THE PUMP CONSOLE WERE CHANGED OUT BUT THIS DID NOT RESOLVE THE ISSUE. THE OXYGENATOR WAS THEN CHANGED OUT AND THE CASE WAS COMPLETED WITHOUT INJURY TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 APEX HP M ADULT HOLLOW FIBER MEMBRANE OXYGENATOR OXYGENATOR, CARDIOPULMONARY BYPASS DTZ SORIN GROUP ITALIA NA 1111150022

    Patients

    Seq Age Sex Outcome Treatment
    1 NP