BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADULT CPB CUSTOM PACK

    MDR report key: 4093113 · Received August 21, 2014

    Report

    Report Number
    2248146-2014-00389
    Event Type
    Malfunction
    Date Received
    August 21, 2014
    Date of Event
    November 14, 2012
    Report Date
    November 14, 2012
    Manufacturer
    DATASCOPE CORP
    Product Code
    DWF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT WAS RETURNED, BUT PICTURES WERE PROVIDED FOR EVAL. BASED ON THE COMPLAINT DESCRIPTION AND THE PICTURES SENT, A KINK FORMED IN THE 3/8" TUBING WHERE IT MAKES THE SHARP TURN IN THE PACK COMING OFF THE OXYGENATOR, THE KINK WAS FORMED AS A RESULT OF THE SHARP TURN WITH LARGE TUBING, THE HEAT DURING THE STERILIZATION PROCESS AND A SHIFT IN THE CONTENTS DURING HANDLING PUSHING THE TUBE BACK. THE HOSP WAS STILL ABLE TO USE THIS KIT. THIS TRAY IS USED ON MANY OTHER KITS WITH NO REPORTED COMPLAINTS OF A KINK IN THIS AREA. THE CAUSE OF THE FAILURE WAS MOST LIKELY SHIPPING RELATED. NO ADD'L ACTIONS WILL BE TAKEN AT THIS TIME FOR THIS ISSUE. THIS COMPLAINT WILL BE RECORDED AND USED TO IDENTIFY ANY TRENDS OCCURRING WITH THIS TYPE OF DAMAGE. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTED THREE ISSUES WITH NEW PACK BUILD: PERFUSION ADAPTER SHOULD BE CAPPED, TUBING KINK OBSERVED, SNAKE WRAP END SHOULD BE INSIDE SASH WRAP. CUSTOMER HAS NOT INDICATED (YET) THAT THESE RENDER ANY PACKS UNUSABLE. INCIDENT OCCURRED DURING USE. NO PERSONAL INJURY/DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    506758 ADULT CPB CUSTOM PACK CARIOPULMONARY DEVICE DWF DATASCOPE CORP BO-TOP 42802 14478-02

    Patients

    Seq Age Sex Outcome Treatment
    1