BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CUSTOM PACK - SMALL PATIENT

    MDR report key: 3980181 · Received June 5, 2014

    Report

    Report Number
    2248146-2014-00087
    Event Type
    Malfunction
    Date Received
    June 5, 2014
    Date of Event
    May 9, 2014
    Report Date
    May 9, 2014
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DTZ
    PMA / PMN Number
    K080592
    Removal / Correction Number
    Z-1689-2015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT STATED THAT THE MCP TUBING PACK LEAKED PRIMING FLUID FROM DE-AIRING PORT DURING PRIMING. THE COMPLAINT WAS INVESTIGATED AND THE FAILURE WAS ASSOCIATED WITH Z-1689-2015. AN INTERNAL INVESTIGATION HAS BEEN OPENED AND CORRECTIVE ACTIONS HAVE BEEN TAKEN. THE COMPLAINT HAS BEEN CONFIRMED. COMPLAINT TRENDS WILL CONTINUE TO BE MONITORED FOR THIS ISSUE. A DEVICE AND LOT HISTORY RECORD 16352-05 REVIEW WAS COMPLETED FOR THE REPORTED PRODUCT. NO NONCONFORMANCES WERE FOUND THAT ARE CONSIDERED TO BE RELATED TO THE EVENT. (B)(4).

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. WHEN THE INVESTIGATION IS COMPLETE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED WITH THE RESULTS. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE QUADROX ID OXYGENATOR IN THE PACK LEAKED PRIMING FLUID FROM THE DE-AIRING PORT DURING PRIMING. NO PATIENT WAS INVOLVED IN THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    330475 CUSTOM PACK - SMALL PATIENT CARDIOPULMONARY DEVICE DTZ DATASCOPE CORP. BEQ-TOP 31204

    Patients

    Seq Age Sex Outcome Treatment
    1